European Commission Confirms Quality of South Korean Active Substances

South Korea – European Commission Confirms Quality of South Korean Active Substances

The European Commission this week confirmed that the quality of active substances produced in the Republic of Korea are in line with EU standards. South...
CDE Shares Chinese Medicine Clinical Research Guidelines for Consultation

China – CDE Shares Chinese Medicine Clinical Research Guidelines for Consultation

China’s Center for Drug Evaluation (CDE) has published six draft technical guidelines about the clinical development of traditional medicines. The guidelines cover the development...
India Posts Guide to Revised Rules on New Drugs and Clinical Trials

India – India Posts Guide to Revised Rules on New Drugs and Clinical Trials

India’s Central Drugs Standard Control Organization (CDSCO) has posted a guide to its new drugs and clinical trials rules. The document addresses common questions...
New pharmaceutical company launches in Asia

Asia – New pharmaceutical company launches in Asia

Roivant Sciences has partnered with one of its 15 spinout companies or “vants” to launch the 16th—a biopharma that immediately inked a potentially $1...
Generic breast cancer drug coming to India

India – Generic breast cancer drug coming to India

Pune-based Emcure Pharma on Wednesday said it is launching the generic version of Eisai Pharma’s breast cancer medicine Eribulin, which will be 40% cheaper...
TGA Overhauls Guidance on Risk Management Plans for Medicines and Biologicals

Australia – TGA Overhauls Guidance on Risk Management Plans for Medicines and Biologicals

Australia’s Therapeutic Goods Administration (TGA) has overhauled its guidance on risk management plans (RMPs) for medicines and biologicals. The guidance features significant changes to...
Guidance for TGO 101

Australia – Guidance for TGO 101

This guidance is to help sponsors and manufacturers of medicines understand the role of the Therapeutic Goods Order No. 101 - Standard for tablets, capsules...
Indian regulators waive clinical trials for drugs approved elsewhere

India – Indian regulators waive clinical trials for drugs approved elsewhere

New drugs approved for use in EU, UK, Australia, Japan and US will be automatically allowed in India, provided clinical trials included Indian...
TGA Overhauls Guidance on Risk Management Plans for Medicines and Biologicals

Australia – Australian manufacturing licences and overseas GMP certification

This step-by-step guide is for: Australian manufacturers of therapeutic goods (medicines, active pharmaceutical ingredients (APIs) and biologicals, human blood and blood components and haematopoietic...
TGA Overhauls Guidance on Risk Management Plans for Medicines and Biologicals

Australia – Updated GMP licence application e-forms

The revised fees and charges model for domestic medicine manufacturers commenced on 1 July 2018. To fully support these changes the TGA needed to update our...

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