Guidelines

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.

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.

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.

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

On 7 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of bevacizumab copy biologicals.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].

On 1 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of adalimumab copy biologicals.

The American Medical Association (AMA) has issued guidelines on naming using United States Adopted Names (USAN), which are unique non-proprietary names assigned to pharmaceuticals sold in the US.

On 23 March 2020, insulin products in the US transitioned to a new regulatory pathway which will allow biosimilars to be developed. The change should make insulin products more affordable for American citizens.