101 results found

Mexico, along with the United States and Canada, was one of the first countries to sign data protection provisions in a free trade agreement.

The frst time that biologics were ofcially recognised in the applicable legislation, the General Health Law, was in June 2009, with the inclusion of article 222-bis defning a ‘biologic/biotechnological product...

El pasado 27 de marzo de 2025, la Comisión Federal para la Protección contra Riesgos Sanitarios ("COFEPRIS") publicó en el Diario Oficial de la Federación (el "DOF") el Acuerdo por el que se establecen acciones de simplificación para trámites que se realizan ante la COFEPRIS.

What are the legal conditions to obtain a patent and which legislation applies? Which products, substances and processes can be protected by patents and what types cannot be patent protected?

En lo que va del 2014 y con base en los derechos fundamentales a la salud y el interés superior de la niñez...

A continuación algunas actualizaciones relevantes respecto de las disposiciones legales e iniciativas en el tema del uso de la Cannabis

Over 20 years ago, derived from the innumerable and uncontainable violations of pharmaceutical patents and for publicity purposes of the patents that protect allopathic medicines...

On May 4, 2026, the White House Office of National Drug Control Policy released the National Drug Control Strategy 20261 (“NDCS 2026”), a document that sets forth the U.S. government’s comprehensive strategy to, among other things, address the synthetic drug crisis (particularly fentanyl and methamphetamine) through a national security approach involving diplomatic, military, financial, and intelligence tools.

In 2021, Maine became the first U.S. state to enact a law imposing reporting requirements and material restrictions on all products containing intentionally added perfluoroalkyl and polyfluoroalkyl substances (PFAS).

In April 2026, Mexico implemented a significant reform of its intellectual property legislation, with the objective to modernise the system, accelerate procedures and provide greater legal certainty to innovators.

Please briefly summarize your country's legislative framework for medicinal products (including biologicals), medical devices, food, and food supplements

The Code of Ethics and Transparency of the Pharmaceutical Industry (Code of Ethics & Transparency).

The primary legislation for the advertising of medicinal products is the General Health Law (Ley General de Salud) (HL), and its Regulations (Reglamento de la LGS en materia de Publicidad) (HLR).

El 7 de junio de 2022 se publicó en el Diario Oficial de la Federación por la Secretaría de Economía (SE) el "DECRETO por el que se expide la Ley de los Impuestos Generales de Importación y de Exportación",...

What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?

The Pharma Legal Handbook answers essential questions about the environment for pharmaceuticals in Mexico. It is a must have for any company operating in the country or looking to enter the market.

Are there any notable trends or recent legal developments in your jurisdiction's pharmaceutical industry? It is expected that the North American Free Trade Agreement will be soon reviewed, renegotiated or terminated.

This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in Mexico.