India – A coronavirus vaccine in 18 months? Experts urge reality check

As a young researcher in the late 1980s, Michael Kinch wanted to solve the biggest medical puzzle of the day: how to design an...
Médicaments : une évaluation rigoureuse et scientifique par la HAS

India – Intas to provide 2 million hydroxychloroquine tablets for WHO study on COVID-19

Intas Pharmaceuticals Ltd. has said it will provide up to two million tablets of hydroxychloroquine to World Health Organisation-endorsed study into the prevention of...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

With the supply of certain APIs limited by the spread of the virus, Indian government orders restrictions on the export of ingredients and formulations...
International scientific guidelines adopted in Australia

Australia – International scientific guidelines adopted in Australia

The TGA closely aligns its regulatory approaches to therapeutic products with those of comparable international regulatory counterparts wherever possible. Technical data requirements for applications to...
Hong Kong regulator will continue to recognize South Korean approvals

China – La Chine vend un médicament contre le coronavirus

L’OMS a averti qu’ils pourraient avoir un vaccin contre le coronavirus de Wuhan dans un peu plus d’un an et demi, tandis que le...
Asia Regulatory Roundup

Asia – Asia Regulatory Roundup

China’s National Medical Products Administration (NMPA) is fast tracking the processing of requests to manufacture and sell face masks and other pieces of medical...
TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – Microbiological quality of medicinal cannabis products

This guidance will assist sponsors and manufacturers of medicinal cannabis products to comply with Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018, referred to...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – India’s CDSCO Publishes List of Drugs Covered by Bioequivalence Study Rules

India’s Central Drugs Standard Control Organization (CDSCO) has published a list of drugs covered by its rules on molecules in category II and IV...
The Essential List of Regulatory Authorities in Europe

Asia – The Essential List of Regulatory Authorities in Asia

To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s...
Indian drugmaker receives warning letter from FDA

India – Indian drugmaker receives warning letter from FDA

The US health regulator has red flagged drug firm GPT Pharmaceuticals for significant violations of good manufacturing norms at its Hyderabad plant. In a...