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....
TGA Creates Guidance on Difference Between Disease Education and Drug Promotion

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The Drug Regulatory Authority of Pakistan (DRAP) has published draft guidance on its priority review and accelerated approval processes.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...
TGA Creates Guidance on Difference Between Disease Education and Drug Promotion

Australia – Advertising guidance for businesses involved with medicinal cannabis products

This guidance aims to assist providers of medicinal cannabis products and therapies (including sponsors, manufacturers, importers, pharmacists, health professionals and marketers) to comply with...
Dialogue with Chinese authorities on medicine regulation

China – Dialogue with Chinese authorities on medicine regulation

The Deputy Commissioner of the Chinese National Medical Product Administration (NMPA), Dr Chen Shifei, visited EMA on 25 October together with a delegation.  The visit took...
Malaysia’s MDA Posts Draft Guidance on Importing Devices for Re-Export

Malaysia – Malaysia Provides Guidance on Regulatory Control of Atypical APIs

The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has shared guidance on atypical active pharmaceutical ingredients (APIs). NPRA expects companies to show batches of atypical...
Dialogue with Chinese authorities on medicine regulation

China – Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies

Hong Kong has proposed legislation to create a regulatory framework for advanced therapy products (ATPs), such as interventions based on cells, genes and tissues....
New Zealand Seeks Feedback on Safety-Focused Changes to Paracetamol Labels

New Zealand – Medsafe Clarifies Process for Extending the Shelf Life of Reference Standards

Medsafe has updated its guideline on obtaining approval for new and changed medicines. The latest text features a new section setting out the process...

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