Guidelines

China’s drug agency proposes changes to patent law

Home/Guidelines | Posted 02/10/2020

China’s National Medical Products Administration (NMPA) has published proposed regulation on patent linkage, which would be similar to the Hatch-Waxman Act in the US.

FDA’s new MAPP explains route for changing ownership of generic drug applications

Home/Guidelines | Posted 25/09/2020

The US Food and Drug Administration (FDA) recently issued a new Manual of Policies and Procedures (MAPP) which outlines how the Office of Generic Drugs (OGD) will process requests to transfer ownership of generic drug applications, and how it will update the Orange Book to reflect those changes.

Center for Biologics Evaluation and Research to regulate biological master files

Home/Guidelines | Posted 04/09/2020

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is now responsible for administering master files for biological drugs, which could create some challenges for biological manufacturers.

Generics reform in Korea

Home/Guidelines | Posted 31/07/2020

The Korean Ministry of Food and Drug Safety (MFDS) has taken action to improve the quality of generic drug products and ensure an efficient and competitive generics market.

EMA and HMA release joint network strategy to 2025

Home/Guidelines | Posted 17/07/2020

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have released a draft joint network strategy for the coming five years. A public consultation on the strategy will be open for two months.

China publishes draft guideline for denosumab copy biologicals

Home/Guidelines | Posted 22/05/2020

Another specific guidance for makers of copy biologicals has been published by China’s Center for Drug Evaluation (CDE). This time the guidance covers denosumab.

China publishes draft guideline for trastuzumab copy biologicals

Home/Guidelines | Posted 15/05/2020

China’s Center for Drug Evaluation (CDE) has published yet more specific guidance for makers of copy biologicals in the country, this time for trastuzumab.

China publishes draft guideline for bevacizumab copy biologicals

Home/Guidelines | Posted 08/05/2020

On 7 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of bevacizumab copy biologicals. This guidance is the second specific guideline released by the CDE in April. The agency also released guidance on adalimumab on 1 April 2020 [1].

FDA issues guidance on hydroxychloroquine, chloroquine

Home/Guidelines | Posted 04/05/2020

The US Food and Drug Administration (FDA) has released new guidance on hydroxychloroquine and chloroquine, which have been raised by President Trump as treatments for coronavirus, despite limited evidence.

China publishes draft guideline for adalimumab copy biologicals

Home/Guidelines | Posted 24/04/2020

On 1 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of adalimumab copy biologicals.