Registration of Biologics in Mexico : Frequently asked Questions
GRP Blog breaks down frequently asked regulatory questions pertaining to biologic registration in Mexico with Health Authority COFEPRIS
China’s CDE publishes draft for a list of Drugs exempt from BE Studies
China’s CDE publishes draft listing 117 drugs that will be exempt from BE studies.
FDA publishes guidance on conducting clinical trials during COVID-19 Pandemic.
On March 18, 2020, FDA made widely available a new Guidance Document on managing clinical trials during the COVID-19 pandemic.
ONE-TIME IMPORT OF BIOLOGICAL PRODUCTS FOR CLINICAL TRIALS IN CHINA
CDE releases No. 94 of 2018 stating that certain biological products maybe imported for a one- time for clinical trial purposes.
Antimicrobial Drugs Clinical Study Regulations Harmonization
The FDA, EMA and PMDA aim at bringing harmonization in regulations related to clinical studies conducted for novel antimicrobial drugs (antibacterial and antifungal) across USA, Europe and Japan.