Guidelines

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.

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 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’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.

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On 7 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of bevacizumab copy biologicals.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

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On 1 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of adalimumab copy biologicals.

Guidelines released on USAN naming

Home/Guidelines | Posted 10/04/2020

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.

FDA opens pathway to biosimilar insulin products

Home/Guidelines | Posted 03/04/2020

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.