The governing laws for  medicinal products, medical devices, food, and food supplements are Republic Act No. 3720 enacted in  1963 which is the Food, Drug and Cosmetic Act, and created the Bureau of Food and Drugs (BFAD),  and was later amended by Executive Order No. 175 in 1987. It was responsible for regulating food, drugs, cosmetics, and medical devices to ensure safety, efficacy, and quality, under the Department of Health (DOH) which was the primary regulatory authority over health products in the Philippines, responsible to protect public health by establishing standards, safety measures, and quality control for food, drugs, cosmetics and devices. RA 3720 was, however, amended by RA 9711 which renamed the BFAD to the Food and Drug Administration (FDA) which remains under the DOH, and strengthened its regulatory capacity and expanded its expanded its scope and enforcement powers to ensure that all Filipinos through the regulation of health products including vapor products and heated tobacco products. Specialized centers were established under this Act which are tasked to regulate the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship, use and testing of health products. These centers are:

• Center for Drug Regulation and Research
• Center for Food Regulation and Research
• Center for Cosmetics Regulation and Research
• Center for Device Regulation, Radiation Health, and Research

The FDA was granted expanded powers and functions which include the power to issue cease and desist orders motu proprio or upon verified complaint for health products and the power to order the ban, recall and withdrawal of any health product found to have caused the death, serious illness or serious injury, or is found to be imminently injurious, unsafe or grossly deceptive, and impose administrative sanctions, e.g., the payment of fines, cancellation of any authorization granted by the FDA, destruction or appropriate disposal of the subject health product, closure of the establishment, and file the appropriate criminal and administrative actions.  The Implementing Rules and Regulations (IRR) of said laws form part of the same.

A. Medicinal Products (Pharmaceuticals) – regulatory process involves the following:

1) Clinical Trials

• Clinical trials for investigational medicines require prior FDA approval and ethics committee approval in line with Good Clinical Practice.
• Specific procedural guidelines are found in FDA Circulars such as FDA Circular 2023-004 — Guidelines on Regulatory Reliance on the Conduct of Clinical Trials, which sets out provisions for clinical trial oversight.

2) Product Registration & Market Authorization

• Certificate of Product Registration (CPR) is required before a medicine, vaccine, biologic or therapeutic product can be sold or distributed.
• Requirements include technical documentation on safety, efficacy, quality, and labeling per FDA technical guidances and standards.

3) Post-Marketing Obligations

• Marketing authorization holders must file periodic safety updates and report adverse drug reactions. Pharmacovigilance is mandatory under Philippine FDA rules and is aligned with international best practice.

B. Medical Devices – regulatory process involves the following:

1) Classification & ASEAN Alignment: The Philippines has been aligning its device regulation with the ASEAN Medical Device Directive (AMDD):

• Administrative Order No. 2018-0002 — “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”
– This AO implements the AMDD requirements, including classification (Class A, B, C, D) and technical dossier requirements based on the ASEAN Common Submission Dossier Template (CSDT).

2) Relevant FDA Circulars for Medical Devices

2.1. FDA Circular No. 2021-002 and Addenda

• FDA Circular No. 2021-002 fully implemented AO 2018-0002 guidelines for device authorization, outlining procedures for filing Certificate of Medical Device Notification (CMDN) and Certificate of Medical Device Registration (CMDR).
• FDA Circular No. 2021-002-A / 2021-002-B (and later extensions) provided transition arrangements and regulatory flexibility during implementation of AMDD requirements.

2.2. FDA Circular No. 2022-008

• Provides Guidelines for Abridged Processing of medical device registration applications if the device is already approved by another ASEAN regulatory authority under AMDD-CSDT.
• It streamlines device entry leveraging ASEAN mutual reliance principles.

2.3. FDA Circular No. 2025-007

• Establishes procedures for initial CMDN application and monitoring via FDA eServices Portal for digital submissions.
• Reflects the FDA’s modernization of device notification systems.

ASEAN Harmonization Frameworks

3) ASEAN Medical Device Directive (AMDD)

• AMDD is the core framework for harmonizing device regulation across ASEAN. It includes risk classification, conformity assessment requirements, and dossier standards (CSDT).
• Philippine implementation through AO 2018-0002 adopts AMDD principles to align local requirements with ASEAN.

4) ASEAN Consultative Committee on Standards and Quality (ACCSQ)

• The ACCSQ and its Medical Devices Product Working Group (MDPWG) support harmonization of technical requirements, mutual recognition arrangements and conformity assessment practices across ASEAN states.
• This regional cooperation assists in regulatory predictability and cross-border acceptance of products.

Food Supplements – Food supplements are regulated by the FDA’s Center for Food Regulation and Research. The process involves the following:

1) All food/dietary supplements, whether local or imported shall be registered with FDA prior to manufacture, importation, exportation, marketing, advertising, selling or distribution, and shall adhere to the mandatory labelling requirements and to indicate on the principal display panel the phrase “Food/Dietary Supplements” and “NO APPROVED THERAPEUTIC CLAIMS”. Food/dietary supplements are subject to FDA monitoring and post-marketing surveillance which includes product recall and product verification. In general, even if a product is labelled as a food/dietary supplement, a product intended to treat, prevent, cure, or alleviate the symptoms of a disease is a drug, and subject to all requirements that apply to drugs;

2) Any FBO (Food Business Operator) found to be in violation of any provision of the FDA issuances shall be a ground for disapproval of application and suspension or cancellation of the CPR or Authorization, plus penalties and sanctions.

Ongoing Obligations After Authorization

A. Medicinal Products

• Maintain GMP compliance and product quality
• Report spontaneous adverse drug reactions
• Submit variations or amendments for changes in formulation, labeling, manufacturing site
• Cooperate in FDA inspections and post-approval monitoring

B. Medical Devices

• Maintain Quality Management Systems and post-market surveillance plans (e.g., Post-Market Alert System as per AMDD Annex 5)
• Record complaint handling, adverse event reporting, field safety corrective actions (FSCA)
• Renew or update CMDN/CMDR and inform FDA of significant changes

C. Food Supplements

• Market monitoring and adverse event reporting
• Compliance with labeling standards and legal provisions governing claims

a. The FDA is the primary authority under the DOH and is mandated to ensure the safety, efficacy or quality of health products which include food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, radiation-emitting devices or equipment, and household/urban hazardous substances, including pesticides and toys, or consumer products that may have an effect on health which require regulations as determined by the FDA.

b. The FDA is also responsible for enforcing the provisions of the following laws:

• RA 9502, or The Universally Accessible Cheaper and Quality Medicine Act of 2008
• RA 6675, or The Generics Act Of 1988,
• RA 10918, or The Pharmacy Law,
• RA 9211, or The Tobacco Regulation Act of 2003
• RA 7394, or The Consumer Act of the Philippines
• RA 7581/10623, or The Price Act
• RA 10611, or The Food Safety Act of 2013
• RA  8172, or The ASIN Law,
• RA 8203, or The Special Law on Counterfeit Drug
• RA 8976, or The Food Fortification Law
• RA 9165, or The Comprehensive Dangerous Drugs Act
• RA 9257, or The Expanded Senior Citizens Act of 2003
• PD No. 881, or The Household Hazardous Act
• EO No. 51, or The Milk Code of the Philippines
• RA 10354, or The Responsible Parenthood and Reproductive Health Bill of 2012
• PD 856, or The Code of Sanitation of the Philippines

c. The FDA has the following specific functions:

• To establish safety or efficacy standards and quality measures for foods, drugs and devices and cosmetics and other health product;
• To undertake appropriate health manpower development and research, responsive to the country’s health needs and problems;
• To assume primary jurisdiction in the collection of samples of health products;
• To analyze and inspect health products;
• To establish analytical data to serve as basis for the preparation of health products standards, and to recommend standards of identity, purity, safety, efficacy, quality and fill of container;
• To issue certificates of compliance with technical requirements to serve as basis for the issuance of appropriate authorization and spot-check for compliance with regulations regarding operation of manufacturers, importers, exporters, distributors, wholesalers, drug outlets, and other establishments and facilities of health products, as determined by the FDA;
• To conduct appropriate tests on all applicable health products prior to the issuance of appropriate authorizations to ensure safety, efficacy, purity, and quality;
• To require all manufacturers, traders, distributors, importers, exporters, wholesalers, retailers, consumers, and non-consumer users of health products to report to the FDA any incident that reasonably indicates that said product has caused or contributed to the death, serious illness or serious injury to a consumer, a patient, or any person;
• To issue cease and desist orders motu propio or upon verified complaint for health products, whether or not registered with the FDA Provided, That for registered health products, the cease and desist order is valid for thirty (30) days and may be extended for sixty (60) days only after due process has been observed;
• To order the ban, recall, and/or withdrawal of any health product, after due process, found to have caused the death, serious illness or serious injury to a consumer or patient, or is found to be imminently injurious, unsafe, dangerous, or grossly deceptive, and to require all concerned to implement the risk management plan which is a requirement for the issuance of the appropriate authorization;
• To strengthen the post market surveillance system in monitoring health products as defined in this Act and incidents of adverse events involving such products;
• To develop and issue standards and appropriate authorizations that would cover establishments, facilities and health products;
• To conduct, supervise, monitor and audit research studies on health and safety issues of health products undertaken by entities duly approved by the FDA;
• To prescribe standards, guidelines, and regulations with respect to information, advertisements and other marketing instruments and promotion, sponsorship, and other marketing activities about the health products;
• To maintain bonded warehouses and/or establish the same, whenever necessary or appropriate, as determined by the director-general for confiscated goods in strategic areas of the country especially at major ports of entry; and
• To exercise such other powers and perform such other functions as may be necessary to carry out its duties and responsibilities.

An applicant whose application for a Certificate of Product Registration (“CPR”) in relation to the registration of pharmaceutical products intended for human use is denied by the FDA may submit a one-time request for reconsideration or a reapplication.

The applicant may opt to request for administrative reconsideration of the disapproval of the application by filing a formal request with the Director General of the FDA within fifteen (15) days from the receipt of the copy of the disapproval of the application. The FDA has sixty (60) working days from receipt of the request to resolve the same.

An appeal from the adverse decision may be taken by filing a Notice of Appeal with the FDA and posting the corresponding appeal bond.

Alternatively, the applicant may opt to re-apply by submitting a requesting for re-application together with additional supporting documents, within forty (40) days from receipt of the denial and by paying the requires re-application fees.

For applications in relation to medical devices, if the applicant fails to comply with the requirements, he or she will be given a chance to re-apply, with a corresponding fee, and to complete the requirement witn sixty (60) days. Failure to comply in this instance is a ground for disapproval of the application.

The applicant may file a Motion for Reconsideration or Appeal to challenge the disapproval of the application in accordance with Republic Act No. 9711 and its Implementing Rules and Regulations.

The legal framework for clinical trials in the Philippines is governed by RA 9711 and further streamlined by Administrative Order (AO) No. 2020-0010.

Application Process

A clinical trial requires authorization from the FDA through a specific approval process. The process involves the filing or submission by a sponsor or a Contract Research Organization (“CRO”) to the FDA, followed by a pre-evaluation of the same for completeness. The application will thereafter undergo regulatory review and afterwards an ethics review by a committee. Clinical trials shall only commence upon approval from both the FDA and the ethics committee.

Requirements

Establishments conducting clinical trials must first secure a License-to-Operate (“LTO”) from the FDA as a clinical trial sponsor. Key documentary requirements include the submission of forms such as the application form, cover letter, information consent forms, pharmaceutical data, and evidence of Good Manufacturing Practice (“GMP”) compliance. The clinical trial protocols must follow the International Council of Harmonization – Good Clinical Practice (“ICH-GCP”) format.

Decision

The FDA has the final decision to approve or deny a regulatory application. This decision shall be provided within 60 calendar days from filing the application. The FDA may disapprove the application due to the applicant’s incomplete response to the FDA’s clarifications on the application. Another ground for denial of the application is the applicant’s falsification or misrepresentation of materials facts or documents in relation to his or her application.

The Philippine Health Research Registry (“PHRR”) is a publicly accessible database on health researches and clinical trials being conducted in the country allowing researchers to input and update data entries. It aims to track on-going and newly-approved researches, avoid duplication of researches, and ensure equal access opportunity for prospective clinical trial participants. The registry is compliant with the World Health Organization (“WHO”) standard for clinical trials registry.

FDA Circular 2012-007 mandates that all clinical trials approved from July 15, 2012 onwards be registered within 30 days after the application to conduct the clinical trials has been granted.

The Data Privacy Act of 2012 applies to the use of data from clinical trials. It is designed to strike a balance between protecting a participant’s right to privacy and promoting the free flow of information for scientific innovation and public health. Pursuant to this act, the data must be used only for the declared purposes in relation to the study and not for other unrelated studies without the participant’s consent. The personal data must be held under strict confidentiality and shall be used only for the declared purpose of the study. Moreover, the participant is given the right to withdraw his or her consent at any time, and to stop the processing of his or her data. Researchers and institutions must implement physical, organizational, and technical security measures such as data encryption to secure data.

Moreover, Administrative Order No. 2020-0010 which provides for the regulation for the conduct of clinical trials, mandates the adherence to the ICH-GCP standards to ensure data integrity and protection of the participants.

One of the objectives of Administrative Order No. 2020-0010, which provides for the regulation of the conduct of clinical trials in the country, is to adopt and implement ICH-GCP standards. Its most recent revision is the ICH E6(R3) Guideline, which final version was adopted on January 6, 2025. This guideline recognizes the use of electronic health records, electronic informed consent forms, electronic signatures, and other digital technologies to aid in keeping conduct of clinical trials in line with technological developments. The Philippines however has not formally adopted this guideline into its local regulatory framework.

The application process for clinical trials in the Philippines is undergoing digitalization. In FDA Circular No. 2023-004 which refers to the Guidelines on Regulatory Reliance on the Conduct of Clinical Trials, the application process begins by submission of the applicant clinical trial application to the FDA electronically through email at [email protected]. The applicant will receive electronic notifications from the FDA regarding his or her application through email.

In the Philippines, manufacturing plants for medicinal products, medical devices, food, and food supplements must obtain a License to Operate (“LTO”) and the applicable product market authorizations from the FDA before beginning operations. A LTO is an authorization issued by the FDA to an establishment to grant permission to undertake a trade or carry out a business activity, such as manufacturing of food products, medicines and medical devices. In relation to this, Administrative Order No. 2020-0017 provides for the revised guidelines on the unified licensing requirements and procedures of the FDA.

For manufacturers applying for LTO, a Risk Management Plan and a Site Master File shall be required for medium and large food manufacturers, drug manufacturers, and medical device manufacturers. Manufacturing plants or facilities are also required to pass a pre-licensing inspection of their facilities before an LTO may be issued.Applications for LTO may be submitted online through the FDA E-service Portal System.

The Philippines follows the WHO’s guidelines on good storage and distribution practices which sets out the steps required by different stakeholders in the supply chain in fulfilling their responsibilities to avoid introduction of substandard and falsified products into the market. This guideline refers to Annex 7 of the WHO’s Technical Report Series 1025 – Annex 7: Good storage and distribution practices for medical products. The guidelines cover various aspects of the supply chain, from manufacturing premises to the entity dispensing the product to a patient.

A documented quality system incorporating Good Storage Practices (“GSP”), Good Distribution Practices (“GDP”), and quality risk management principles is mandatory, with clear responsibilities assigned to senior management and personnel. All activities, including receipt, storage, and dispatch, must follow written procedures. Accurate, legible, and traceable records are necessary for all transactions. Keeping an accurate record of batch numbers as well as expiry dates ensure product traceability and facilitate recalls when necessary.  Products must be transported in suitable, appropriate vehicles that maintain specified storage conditions such as temperature control.

Enacted in 2008, Republic Act No. 9502, or the “Universally Accessible Cheaper and Quality Medicines Act,” authorizes the Philippine President to set maximum retail prices (“MRP”) on drugs and medicines based on recommendations from the Secretary of the Department of Health (“DOH”). Furthermore, the DOH Secretary is empowered to include additional drugs in this regulated price list whenever it serves the public interest. The MRP applies to all public and private retailers, including hospital pharmacies, drugstores, health maintenance organizations, supermarkets, and convenience stores.

Advertising of pharmaceutical products and medical devices is generally governed by the provisions under the Implementing Rules and Regulations of the Food and Drug Administration Act of 2009 (“FDA IRR”) and other regulations issued by the FDA. The FDA is empowered to regulate the promotion and advertisement of health products in the country which include food, drugs, devices and other products that may have an effect on health.

The FDA mandates that all advertisements, promotions, sponsorship, and other marketing activities about the health product must adhere to its standards, guidelines, and regulations. These advertisements, promotions, sponsorship, and other marketing activities on health products refer to those that are addressed to the general public in any form of media.

The Intellectual Property Code of the Philippines (“IP Code”) or RA 8293 is the governing law that applies to patents and trademarks for medicinal products, medical devices and food supplements. It was signed into law on June 6, 1997 and took effect on January 1, 1998. It was enacted  to simplify the registration of patents, trademarks, and copyrights, ease technology transfer regulations, and strengthen the enforcement of intellectual property rights nationwide.

The Universally Accessible Cheaper and Quality Medicines Act of 2008 is a law that amended the IP Code. This amendment allows parallel importation of genuine patented medicines from abroad to promote competition, reduce prices and increase the public’s access to medicines. It also introduced other amendments to certain provisions in the IP Code in relation to patents for drugs and medicines in line with its purpose to promote and ensure access to affordable quality medicines for all.

In the Philippines, the making, using, offering for sale, selling, or importing a patented product or product obtained directly or indirectly from a patented process, or the use of a patented process without the authorization of the owner of the patent is considered as patent infringement. Patent infringement is actionable by administrative action before the IPOPHL, or the specially designated commercial Regional Trial Court (RTC).  A criminal action is only available on the second offense for patent infringement.

Possible defenses against patent infringement include:

• prescription of the action for infringement – must be brought within 4 years from the time the cause of action accrued;
• the invalidity of the patent on grounds such as lack of novelty, insufficient disclosure, or that the patent is contrary to public order or morality;
• exhaustion of national or international rights, particularly for pharmaceuticals;
• private non-commercial acts with no injury to the patent holder;
• acts exclusively for experimental use of the invention for scientific purposes or educational purposes and other activities directly related to such scientific or educational experimental use;
• where the act consists of preparation for individual cases of a medicine in accordance with a medical prescription in a pharmacy or by a medical professional,
• in the case of drugs and medicines, where the act includes testing, using, making or selling the invention, including any data related to it, solely for purposes reasonably related to the development and submission of information and issue of approvals by government regulatory agencies required under any law of the Philippines or of another country that regulates the manufacture, construction, use or sale of any product;
• where the invention is used in any ship, vessel, aircraft, or land vehicle of any other country entering the territory of the Philippines temporarily or accidentally: provided that such invention is used exclusively for the needs of the ship, vessel, aircraft, or land vehicle and not used for manufacturing of anything to be sold within the Philippines.

The FDA  requires all health products to have a valid Certificate of Product Registration (CPR) or Certificate of Cosmetic Notification (CCN) and a License to Operate (LTO) for manufacturers/importers. Brands must comply with strict labeling, including ingredient lists, manufacturer details, and truthful, evidence-based claims. Labels must contain the product name, net content, ingredient list, manufacturer/packer name and address, country of origin, and lot code.  Under Administrative Order No. 2005-0016, no brand name that are obscene, offensive, scandalous or otherwise contrary to public morals. Administrative Order No. 2014-0030, the use of the brand name or trademark shall be subject to restrictions such as:

• The brand name or trademark must not be misleading, deceptive, confusing, or is likely to create erroneous impression regarding its character or nature in any respect.
• No brand name shall be allowed that is identical to those already registered with the FDA in the same product classification or those that are obscene, offensive, scandalous or otherwise contrary to public morals.
• An identical brand name may be allowed provided that it is authorized by the same brand owner.

The Consumer Act of the Philippines (Republic Act No. 7394) enacted in 1992, serves as the legal framework for product liability, particularly regarding food, drugs, cosmetics, and devices. It establishes strict standards for safety, quality, as well as for appropriate labelling, and creates the manner by which a consumer can obtain redress against injuries caused by defective medical products and devices. Pursuant to this Act, entities whether Filipino or foreign that are involved in the production or importation of goods are subject to strict liability, or liability regardless of fault, for damages caused to a consumer arising from any phase of product creation, that is, from design and assembly to packaging, as well as for failure to provide adequate safety warnings and usage instructions. Penalties for violation of the provisions of the Consumer Act include the payment of fines as well as imprisonment.

The DOH is the agency concerned with the enforcement of the State’s policy to ensure safe and good quality of food, drugs, and devices. It is tasked to regulate the production, sale and distribution of food, medicinal drugs and medical devices to ensure their quality, efficacy and safety. Hence, it has the authority to ban, recall or withdraw from the market drugs and medical devices that are unregistered, unsafe, inefficacious or of doubtful therapeutic value.

The DOH is tasked with establishing the safety and quality standards for foods, drugs, and medical devices. It is empowered to, among others, conduct inspection and analysis of such products to determine their conformity with established standards, monitor the market for the presence of hazardous or non-certified products, and facilitate the licensing of manufacturers, importers, and distributors, as well as the registration of their medical products and devices.

Violations of the relevant provisions of the Consumer Act of the Philippines as well as the FDA Act entail criminal, civil, and administrative liabilities. Engaging in prohibited activities such as the manufacture, sale, or distribution of adulterated, mislabelled, or unregistered food, drugs, and devices is strictly punishable under this law. Upon conviction, the offender may suffer the penalty of imprisonment together with the payment of a fine.

Administrative sanctions for violation of the provisions of the Consumer Act include the payment of fines, as well as those stated under Letter of Instructions No. 1223 which are the seizure or condemnation of food, drugs or devices that are adulterated, counterfeited or misbranded, and the closure or any food, and drug establishment for violation of the provisions of the Consumer Act.

Under the Consumer Act, manufacturers and processors are responsible for the quality and safety of their products. If a consumer suffers injury, illness, or death due to a defective, unsafe, or substandard product, a civil liability for damages arises. If it is not possible to identify the manufacturer or the processor, or the supplied product does not clearly identify the manufacturer, producer or importer, the tradesman or the seller can be held liable for damages.

While there is no specific legislative and regulatory framework for digital health applications in the Philippines, there exists a guideline for the adoption and implementation of telemedicine, namely, Joint Administrative Order No. 2021-0001. The term “telemedicine” refers to the delivery of health care services, where distance is a critical factor, by health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries. Said guidelines were created due to recent events such as the coronavirus pandemic where digital health technology is needed to ensure access to and delivery of continuous health services to patients in view of the lockdown.

Under the guidelines, the practice of telemedicine shall only be allowed to licensed physicians and shall be governed by the following principles:

• Telemedicine consultation should not be anonymous. Both patient and licensed physician should be able to know, verify, and confirm each other’s identity
• Proper informed consent must be obtained from the patient before any collection of personal data for every consultation. Consent may be in writing, electronic, or recorded means, and shall contain all the necessary information regarding the features of the telemedicine consultation that shall be fully discussed with the patient
• the patient-physician relationship shall be based on full knowledge of the patient’s medical history and a virtual physical examination. Only the type and extent of patient information required to render a medical diagnosis and give treatment shall be gathered.
• the patient-physician relationship shall respect both patient and physician autonomy. At any step, the licensed physician can refer or request for face-to-face consultation. The patient has the right to discontinue the telemedicine consultation at any stage.
• the right to privacy of health information shall be protected at all time. All licensed physicians providing telemedicine services shall uphold the data privacy rights of patient.
• the principle of privileged communication between the licensed physician and the patient shall be observed at all times.
• All telemedicine consultations by licensed physicians shall have proper documentation.
• All licensed physicians shall be authorized to issue electronic consultation documents such as electronic clinical abstract, consultation summary, prescription, and the like.

The Universally Accessible Cheaper and Quality Medicines Act of 2008 is a law that aims to promote and ensure access to affordable quality drugs and medicines for all. To attain this goal, the State recognizes that an effective competition policy in the supply and demand of quality affordable medicines is needed. The law amended the IP Code to allow parallel importation of drugs with existing active patents if the same is sourced from the same manufacturer or its licensee abroad. Moreover, the law expanded the grounds for compulsory licensing, which is defined as a license granted by the Director General of the Intellectual Property Office to exploit a patented invention without the permission of the patented holder either by manufacture or by parallel importation.

Furthermore, the Cheaper Medicines Act has provisions aimed at ensuring adequate supply of medicines such as the following:

• No manufacturer, importer, trader, distributor, or wholesaler shall withhold from sale or refuse to sell any drug or medicine without sufficient reason.
• Any manufacturer, importer, trader, distributor, wholesaler, retailer, or any person engaged in the distribution of drugs and medicines who commits any act of illegal price manipulation such as hoarding, profiteering, or forming a cartel shall suffer the penalty of imprisonment or a fine.
• Drug manufacturing companies operating in the Philippines are required to produce, distribute and make widely available to the general public an unbranded generic counterpart of their branded product.

There is also a pending legislation that would allow the stockpiling of essential and critical drugs and other medical devices to address public health emergencies. This is House Bill 9456, also known as the Health Procurement Stockpiling Act, a bill that is approved already by the House or Representatives. The bill creates the Health Procurement and Stockpiling Bureau which will carry out this mandate such as undertaking the procurement process. It is currently pending in the Senate.

The marketing of medicinal products and medical devices is regulated by the FDA thru  Administrative Order No. 2015-0053. The following standards include:

• Information provided by manufacturers and distributors to health professionals shall be restricted to evidence-based scientific data;
• Promotional materials provided by industry to health care providers must comply with existing FDA regulations, substantiate claims with timely scientific evidence, and lay down the risks and the benefits;
• One-sided information, superlatives or exaggerations without supporting data, unsupported comments about competitors, unreferenced claims about side effects, safety and efficacy, are prohibited;
• The word “new”, shall not be used unless the product or indication has been available and generally promoted for less than 12 months.
• Medical representatives shall not directly communicate to patients or their families in the promotion of prescription products
• No company shall employ or contact any health care provider or health worker to promote, advertise or endorse any pharmaceutical product or medical device in mass media, print, audio visual display or social media

a. Magsasaka at Siyentipiko Para sa Pag-Unlad ng Agrikultura, et al. v. Secretary of the Department of Agriculture, et. al. (CA-G.R. SP No. 00038, April 17, 2024)

This case involves two genetically-modified organisms (“GMOs”): Golden Rice and Bacillus thuringiensis eggplant or Bt Eggplant. Golden Rice was developed through recombinant DNA techniques to express levels of pro-vitamin A (as beta-carotene) in the rice endosperm, which is converted eventually in the body as Vitamin A. This was developed in order to mitigate Vitamin A deficiency by supplying consumers whose diet is primarily rice-based with Vitamin A. The Philippine Rice Research Institute, in partnership with the International Rice Research Institute (IRRI), is the lead agency the develops Golden Rice in the country. Magsasaka at Siyentipiko Para sa Pag-Unlad ng Agrikultura (“MASIPAG”) and other environmental groups opposed the commercialization of Golden Rice due to the alleged harmful and adverse effects of GMOs on public health and environment and called for the stoppage of its field trials. Bt Eggplant, on the other hand was developed using genetic engineering methods to provide resistance against the eggplant fruit and shoot borer (“EFSB”) pests. It is owned by University of the Philippines Los Banos (“UPLB”).

MASIPAG and Greenpeace, together with other environmental groups, filed a Petition for the writ of Kalikasan before the Supreme Court alleging that the field trials concerning the GMOs violated their constitutional right to a healthful and balanced ecology. The Supreme Court thereafter referred the case to the Court of Appeals for hearing and  reception of evidence.  Both parties presented their own expert witnesses.

The opinion of the expert witnesses for all parties suggest that no consensus can be reached regarding the safety or harmful effects of Golden Rice and Bt Eggplant on humans and the environment.

The Court applied the precautionary principle and issued the writ of Kalikasan. This writ is an extraordinary remedy covering environmental damage of such magnitude that will prejudice the life, health or property of inhabitants in two or more provinces or cities.  The precautionary principle states that when the risks of harm are uncertain, when there is a possibility of irreversible harm, and there is a possibility that that the harm may be of a serious nature, the case for the precautionary principle is strongest. When in doubt, the courts must resolve in favor of the constitutional right to a balanced and healthful ecology. Accordingly, the Court granted the privilege of the writ of Kalikasan, directed the UPLB to cease and desist from commercially propagating Bt Eggplant, ordered the PRRI to cease and desist propagating and conducting activities relating to Golden Rice, ordered the concerned agencies to submit to the Court concrete mechanisms to monitor the research and commercialization activities conducted in relation to the GMOs and to strengthen the risk assessment procedure in conduct of the same.

b. Princess Sherisse Abines, et.al. v. Francisco T. Duque III (in his capacity as the Secretary of Health), et al.( G.R. NO. 235891, September 20, 2022)

This case involves a Petition for a Writ of Continuing Mandamus filed before the Supreme Court by the petitioners for alleged violations to their right to health. The petition was filed by 74 children, represented by their parents (collectively, petitioners), who were inoculated with Dengvaxia, the dengue vaccine developed by Sanofi Pasteur. The petition was filed directly with the Supreme Court and sought the issuance of a writ of continuing mandamus against DOH Secretary Francisco Duque III, and other government officials who implemented the Dengvaxia vaccination program. The petitioners allege that the respondents failed to protect the right to health of those who were subjected to the vaccination program. Further, the petitioners claim that they were used a “guinea pigs” in an experiment conducted by Sanofi Pasteur and the government. The petitioner-children alleged that their health and lives were put at risk due to Dengvaxia.  The Supreme Court, however, dismissed the petition on technicalities, to wit:  (i) there was a violation of the doctrine of hierarchy of courts. This doctrine demands that parties seek recourse first from lower courts sharing concurrent jurisdiction with a higher court. Direct invocation of the Court’s original jurisdiction is allowed only for exceptional reasons which are not present in this case, (ii)  Mandamus cannot lie against the respondents because the reliefs involve the performance of purely discretionary functions, which the Court cannot interfere with. Neither the petitioners nor the Court can dictate the respondents on how to conduct the immunization program, (iii) the concept of continuing mandamus applies only to environmental cases, hence, the Court cannot grant the issuance of a writ of continuing mandamus because the dispute does not involve the violation of an environmental law or right.  And further, the reliefs sought have been satisfied by the DOH which had submitted the necessary reports to the Congress while the FDA has been studying the safety and efficacy of Dengvaxia. The DOH has been monitoring the inoculated children and offered free medical services to them.

c. Department of Health v. Philippine Tobacco Institute (G.R. No. 200431, July 13, 2021)

Does the FDA have regulatory powers over tobacco products? The controversy arose when the Philippine Tobacco Institute (“PTI”) alleged that the Inter-Agency Committee Tobacco (“IAC-Tobacco”) had exclusive jurisdiction over tobacco products, including its health aspect, under RA 9211,  and that the FDA has no regulatory power over the same. The Supreme Court held that RA 9711 was enacted to strengthen the State’s regulatory capacity and enforcement compliance with regulations over all health products which include tobacco products. Tobacco use, as well as exposure to second hand smoking, pose health hazards and thus affect health. Further, the FDA IRR is aligned with the  Philippines’ international commitment under the World Health Organization Framework Convention on Tobacco Control (“WHO FCTC”) to give priority to the right to protect public health by allowing the FDA to implement tobacco control measures to substantially reduce the prevalence of tobacco use and exposure to tobacco smoke.  Thus,  the Supreme Court  ruled that tobacco products, being undoubtedly health products, aptly falls under the regulatory authority of the FDA.

d. Venus Commercial Co., Inc. v. DOH-FDA (G.R. No. 240764, November 18, 2021)

This case concerns the FDA’s power of enforcement. The case arose when the FDA received information regarding an alleged high lead content of Artex Fine Water Colors manufactured by Venus Commercial Co., Inc. (“Venus”). Acting on such information, the FDA purchased samples of their water colors and subjected them to laboratory analysis. The results showed that the amount of lead present in each sample exceeded the maximum limits set by the FDA.

As a consequence, the FDA Acting Director-General issued an order to conduct inspection, seizure of the subject water colors, and/or padlocking of the establishment. The FDA agents went to Venus’ premises to implement the order but was hindered by security guards. The FDA promised to return to implement the order. On the other hand, Venus filed an action to restrain the FDA from enforcing the order on the grounds that the search and seizure was illegal and violated its rights, and that the same must be in the form of a judicial warrant or court order. It further claimed that there was violation of its right to due process and its right against self-incrimination.

The Supreme Court ruled that the search and seizure conducted by the FDA was a valid warrantless search and seizure because such search is incident to inspection, supervision, and regulation, sanctioned by the State in the exercise of its police power. This type of search is known as administrative search and is a valid type of warrantless search.

In the Philippines, House Bill 3115 or the Act Establishing the Philippine Electronic Heath or eHealth System aims to provide the public with effective telehealth services, and to ensure that healthcare can reach remote communities in the country where hospitals and specialists are scarce. With a telehealth system, consultations, diagnostics and follow-ups may be done without need for travel, which can save time and money.

With regards to the use of artificial intelligence, the FDA released last year a draft circular on the Regulation of Medical Device Software (“MDSW”) which serves as a guide that will provide a framework for accurate classification and establish clear benchmarks for effective regulatory practices. The FDA recognizes that MDSW is unique among medical devices as it plays a crucial role in clinical decision-making as it can offer patient-specific solutions based on data inputs. Integrating with artificial intelligence (AI) and other digital health technologies enhances its capabilities even further. The rapid evolution of MDSW, particularly with diagnostics driven by artificial intelligence, presents regulatory challenges in risk classification, patient safety and data privacy; hence the need for a clear regulatory framework for classifying medical devices and its updates.

Five key developments with regards to the life sciences sector:

a. Creation of pharma ecozones. Under the Philippine Development Plan for the years 2023-2028, the Philippine Economic Zone Authority (“PEZA”) is tasked to implement the ecozone transformation roadmap by creating different ecozone types which includes pharmaceutical companies. These pharmaceutical zones shall host companies engaged in all aspects of medical and drug-related manufacturing activities including research and development as well as clinical trials. Talks with Filipino pharmaceutical companies for the establishment of a modern pharmaceutical park in the Philippines are ongoing.

b. Modernization of the FDA online system. The FDA recently launched its new and improved website. The FDA website has long been criticized for its outdated online services, making it hard for stakeholders to avail of the FDA’s online services. Recognizing these challenges, the FDA took steps to upgrade its technology platforms to improve digital access and create a user-friendly system that can better support the public. The FDA is upgrading its regulatory systems, with the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) already offering enhanced, reliable data for the public to access. Similar improvements are coming to the Center for Drug Regulation and Research (CDRR), aiming to boost accuracy of drug verification, continuing the agency’s modernization across all centers.

c. Artificial Intelligence Driven Healthcare. Through its Digital and Frontier Technologies for Health (DFTF) Program, the Department of Science and Technology-Philippine Council for Health Research and Development (“DOST-PCHRD”) is promoting Artificial Intelligence (“AI”)-driven healthcare in the Philippines. By supporting research that integrate intelligent systems into diagnostics and health surveillance, the council aids in connecting hospital-based care with community-level monitoring. Among the projects supported include the CHERISH project which uses AI to analyze chest X-rays and detect pneumonia, as well as determine its cause – whether bacterial or viral. The model demonstrated 100% sensitivity and 99% specificity. These results which are obtained through AI can provide insights to health care professionals who can incorporate the same into their clinical evaluations.

d. Designation of the Virology and Vaccine Institute of the Philippines (VIP) as the country’s premier national institute for virology research and vaccine development. President Ferdinand Marcos, Jr. signed into law the VIP act on September 12, 2025. The DOST led this initiative which aims to strengthen the public’s health resiliency and preparedness for future outbreaks. Viral diseases common to the country include Influenza, Chicken pox, Dengue, Hepatitis and Measles. Viruses are fast evolving threats to human, animal and plant health, hence the need for a dedicated institution to focus on the research and development of diagnostics and vaccines to combat viral diseases. To address plant diseases, the VIP is already developing an early detection system for the Tomato Leaf Curl Virus which affects solanaceous crops. The VIP performs a number of critical functions such as undertaking discovery programs in virology, and development of diagnostics and therapeutics aimed DOST of Science and Technology will work closely with the DOH, the Department of Agriculture, and other relevant agencies to implement the program.

e. Opening of a new gene-based Cancer Treatment Facilities. The University of the Philippines-Philippine General Hospital (“UP-PGH”) Cancer Institute opened two new facilities aimed at providing “precision medicine” which is described as providing the right drug at the right dose for the right person. This method heavily depends on the patient’s genetic makeup to determine the proper diagnosis and treatment, hence the need for gene-based facilities. The launch of these gene-based facilities is a milestone in the Institute’s mission to offer world-class cancer care in the Philippines.

Such development is of particular significance given that neoplasms which are masses of tissue formed by abnormal cell growth were the second leading cause of death in the country, based on a study released by the Philippine Statistics Authority on March 2025. Another report in 2022 also revealed that a significant number of Filipinos or approximately 466,000 Filipinos were living with cancer.

The Center for Precision Medicine is located behind UP-PGH’s Ward 12. The UP-PGH Cancer Institute also has a sequencing unit that is situated within its Molecular Pathology and Genomics Laboratory.