On February 18, 2020, China's National Center for Food Safety Risk Assessment (CFSA) published a notice soliciting public comments on 10...

The China Food and Drug Administration (CFDA) published its proposed amendment of the Drug Administration Law (DAL) and the Drug Registration Rules (DRR) for public comments. This Alert summarizes the key changes.

Patent linkage refers to the relationship between the market approval for a generic drug and the patent status of its branded equivalent.

In order to encourage the development of innovative pharmaceutical companies in China, patent term extension (PTE) is introduced for the first time to the amended Chinese Patent Law...

中国国家知識産権局の復審・無効審理部が上海市で医薬品特許紛争の早期解決制度における行政裁決について調査を実施し、関連企業や関係者

China will launch further reforms in the pharmaceutical sector as part of the healthcare reform initiatives announced by the State Council in its February 9, 2017 Circular on Several Opinions Concerning Further Reforms of the Policies Governing Drug Production, Circulation and Usage (the "Circular No.13").

The applicants shall ensure the completeness of clinical trial data.

China's Government will launch several incentives to enhance accessibility of innovative drugs, especially imported oncology drugs.

The China Food and Drug Administration (CFDA) has published its proposed amendment of the Medical Device Regulations (MDR), previously known as the State Council Order # 650, for public comments.

Cultured meat is meat produced by in vitro cell culture of animal cells, instead of from slaughtered animals.

China has become the world’s largest market for generic pharmaceuticals. Generics account for more than 90% of China’s total pharmaceutical market.

On 8 January 2013, SFDA released a report concerning the results of its continuing investigations into online pharmaceutical trading activities conducted pursuant to their notice issued by them on 24 February 2012.

A discussion on the investigations relating to the ever-increasing online sale of pharmaceuticals in China.

When determining whether the replacement between two groups in a pharmaceutical compound is common knowledge in the art, bioisosterism may generally be considered.

The new Chinese Patent Law is confirmed to take effect on June 1, 2021.

In the US, the Orange Book is a publication from the US FDA that identifies drug products with marketing approval from the FDA and related patent and exclusivity information.

This is the October 2021 version of this guide, as there have been many developments shortly after my first July version was finished on 19 July 2021.

Geographical indications (GIs) may not receive the most fanfare among different forms of Intellectual Property, but they are crucial to discerning consumers. People pay a premium for Cuban cigars

China's recent drug regulatory reform has emphasized that clinical trial data must be authentic and reliable.

On May 19, 2015, the China Food and Drug Administration ("CFDA") unveiled the Technical Guideline Governing Medical Device Clinical Evaluation ("Guideline").