Australia Preps for Medicine Ingredient Name Changes

Australia – Australia Preps for Medicine Ingredient Name Changes

As part of a push to align the names of Australia’s medicinal ingredients with names used internationally, Australia’s Therapeutics Goods Administration (TGA) has been...
TGA’s UDI Proposal Gets Broad Industry Support

Australia – Therapeutic goods advertising: Ensuring ‘natural’ claims are not misleading

Introduction The use of the term 'natural' (and related terms such as 'naturally derived', 'sourced from nature', 'all natural') in therapeutic goods advertising is regulated...
Chinese NMPA publishes UDI system rules for medical device registrants

China – How trade war with China could hit US pharmaceutical makers

The United States’ heavy reliance on China for prescription drugs is becoming a national security concern. The concern is that China could weaponize its...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – CDSCO Creates Process for Companies That Lack Data Supporting Their FDCs

India’s Central Drugs Standard Control Organization (CDSCO) has established an authorization process for fixed-dose combinations (FDCs) that came to market despite lacking the required...
Seegene's COVID-19 test authorized for emergency use in Korea

South Korea – EU regulators approve export of active ingredients from S. Korea

European regulators have given their South Korean counterparts the stamp of approval, recognizing that Korea’s regulatory framework for active ingredients align with the EU’s...
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...
Chinese NMPA publishes UDI system rules for medical device registrants

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

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...

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