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...
Stem cell-based Parkinson's therapy tested in Japan

Japan – Stem cell-based Parkinson’s therapy tested in Japan

Japanese researchers said on Friday (Nov 9) they have transplanted stem cells into the brain of a patient in the first stage of an...
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,...
New Zealand Seeks Feedback on Safety-Focused Changes to Paracetamol Labels

New Zealand – New Zealand Pushes Ahead With Paracetamol Reclassification Despite Objections

Regulators in New Zealand have reaffirmed their intention to reclassify modified-release paracetamol as a restricted medicine. Officials proposed strengthening the restrictions on the medicine...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – COVID-19 vaccine guidelines in India

India’s Central Drugs Standard Control Organization (CDSCO) has published draft guidelines about the development of COVID-19 vaccines, falling in line other regulatory agencies by...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – India Advances Plan to Create Mobile Drug Testing Laboratories

ndia’s Drugs Consultative Committee (DCC) has backed plans to create mobile laboratories to test drugs around the country. The plans call for one mobile...
Australian regulatory action on breast implants and breast tissue expanders

Australia – COVID-19 vaccines undergoing evaluation

Before any COVID-19 vaccine is approved for use in Australia, it will be subject to the well-established and rigorous assessment and approval processes of...
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...

International – Asia-Pacific Roundup

Australia's Therapeutic Goods Administration (TGA) and its international collaborators in the Access Consortium have posted their approach to the regulatory evidence requirements for COVID-19...
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...

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