The Essential List of Regulatory Authorities in Asia

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...
India Gives Device Manufacturers Another Year to Meet Drug Regulations

India – Food or drug? Government to take a call soon

Is a multivitamin preparation a drug or just plain old food? And what about pick-me-ups like Revital or supplements like Ferradol? Given the confusing...
Australian TGA publishes Uniform Recall Procedure update

Australia – Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)

The Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG) provides information to advertisers about: advertising compliantly under the regulatory framework the requirements for advertising different types...
FDA can't regulate contrast agent as drug, judge rules

South Korea – Samsung executives found guilty of destroying evidence in fraud case

Samsung BioLogics has fought accusations that it inflated the value of its Biogen biosimilar joint venture Samsung Bioepis, breaking accounting rules in the process. Counter...
Pakistan’s DRAP Creates Guidelines on Conducting Clinical Trials

Pakistan – Pakistan’s DRAP Creates Guidelines on Conducting Clinical Trials

The Drug Regulatory Authority of Pakistan (DRAP) has published guidelines on the conduct of clinical trials. DRAP’s guideline covers many topics specific to the...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

TGA has published advertising guidance for providers of stem cells and other human cell and tissue (HCT) products. The agency created the guidance after...
New Zealand Seeks Feedback on Safety-Focused Changes to Paracetamol Labels

New Zealand – New Zealand Seeks Feedback on Safety-Focused Changes to Paracetamol Labels

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is seeking feedback on planned changes to the warning and advisory statements for paracetamol....
Australian TGA publishes Uniform Recall Procedure update

Australia – TGA Creates Guidance on Difference Between Disease Education and Drug Promotion

TGA has published guidance for providers of disease education activities. The guidance is intended to help such organizations to continue raising awareness of diseases...
Pakistan’s DRAP Creates Guidelines on Conducting Clinical Trials

Pakistan – Pakistan Posts Draft Accelerated Approval Guidelines in Flurry of Activity

The Drug Regulatory Authority of Pakistan (DRAP) has published draft guidance on its priority review and accelerated approval processes. DRAP released the guidelines alongside...

NOS PROCHAINES FORMATIONS