Guidelines
FDA new and revised guidances for complex generics
The US Food and Drug Administration (FDA) has announced new and revised product-specific guidances to support the development and approval of safe and effective complex generic drug products.
UK releases post-Brexit biosimilar guidelines
The UK has left the European Union (EU) and the exit transition period ends in January 2021. At this point, the regulation of medicines and devices will be transferred to the UK's Medicines and Healthcare products Regulatory Agency (MHRA). This move away from EU regulation will involve some significant changes.
FDA’s new MAPP explains route for changing ownership of generic drug applications
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
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
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
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.
FDA issues guidance on hydroxychloroquine, chloroquine
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 denosumab copy biologicals
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’s drug agency proposes changes to patent law
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.
China publishes draft guideline for trastuzumab copy biologicals
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.
