China Revises the Provisions for Lot Release of Biological Products
Pursuant to the new Vaccine Administration Law and the revised Drug Administration Law, the Provisions for Lot Release of Biological …
South Korea MFDS issues 3 Q&As relating to GMP, Official Communication Channel , Drug Approvals and other topics
South Korea Ministry of Food and Drug Safety (MFDS) has issued 3 Q&As in late-November/early-December 2020 relating to GMP, Official …
USA, FDA’s launch of purple book, an online database for biologics
The US Food and Drug Administration launched the first version of the Purple Book, which is a searchable online database …
World Health Organization first bio-similar pre-qualification
WHO (World Health Organization), pre qualified their first bio-similar. This newly pre qualified medicine is Samsung Bioepis’ Ontruzant which is …
More News
Australia
Biologicals
Biologics/Biosimilars
Canada
China
Clinical Trials
Cosmetics
eCTD
EU
Global
Health Supplements
Herbal/Traditional Medicines
Hong Kong
India
Indonesia
Japan
Korea
Malaysia
Medical Devices
New Zealand
Pharmaceutica Drugs
Pharmaceutical Drugs
Philippines
Singapore
Sri Lanka
switzerland
Taiwan
Thailand
United Kingdom
United States
Vietnam