TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

Australia – Transition to new GMP requirements for medicinal products

The TGA will adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-14 (PIC/S Guide to GMP), excluding Annexes 4,...

China – Sinovac reveals positive preliminary data for COVID-19 vaccine

Sinovac’s candidate – dubbed CoronaVac – induced a positive immune response against COVID-19, according to a statement released by the Chinese biotech company. The early-stage trials...
Indian drugmaker receives warning letter from FDA

India – 14 vaccine candidates from India look promising

At the global level, there are at least 90 candidates in the fray. Efforts are on with 30 vaccine potentials by industry and academicians...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – India lifts export restrictions on paracetamol API

India has ended restrictions on export of active pharmaceutical ingredients (API) of common pain reliever paracetamol, the Directorate General Of Foreign Trade (DGFT) said...
Hong Kong regulator will continue to recognize South Korean approvals

China – New Drug Approvals in China in 2019

The NMPA defines Category 1 innovative drugs as drugs not approved anywhere in world. In 2019, 12 of the 53 new drug approvals were...
TGA Updates Guidance on the Testing of Biological Medicines

Australia – Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines

The Australian regulatory guidelines for listed medicines and registered complementary medicines (published May 2020) replaces ARGCM V8.0. The new version reflects recent reforms to the regulatory...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – India to test four drugs as part of WHO trial

India will start clinical trials for four drugs as part of the World Health Organization’s Solidarity trial that’s aimed at finding a quick cure...

Australia – Study tests ivermectin in lab-grown COVID-19 cells

An anti-parasitic drug that is available around the world stops SARS-CoV-2 coronavirus from replicating in cells within a couple of days, according to findings...
Indian drugmaker receives warning letter from FDA

India – India withdraws export ban on antimalarial drug

India has lifted its near-total ban on the export of hydroxychloroquine — a anti-malarial drug touted as a potential coronavirus prevention and cure —...

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...

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