Asia – Asia-Pacific Roundup

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is going ahead with its planned changes to good manufacturing practices (GMPs) after receiving...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – Covishield or Covaxin: Mutant strains in some West Bengal patients raise concerns...

The detection of double mutant Covid strain in some Bengal patients has left experts and those waiting to get vaccinated worried about the efficacy...

China – Chinese company approved for inhaled COVID-19 vaccine trial

China’s CanSino Biologics Inc (CanSinoBIO) said on Tuesday it won approval for a clinical trial in the country to develop a COVID-19 vaccine for...

Australia – Medicine packaging definitions for sponsors

Packaging terms are important to know to ensure sponsors and manufacturers are following the rules when labelling their medicines. Therapeutic goods legislation, GS1 General...
Australian regulatory action on breast implants and breast tissue expanders

Australia – Standard for serialisation and data matrix codes on medicines

This guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes. It describes the requirements in...

Australia – Melbourne-made COVID-19 vaccine now available

The Melbourne-manufactured AstraZeneca vaccine is now available for Australians, with the Therapeutic Goods Administration (TGA) this evening approving the release of the first four...

Australia – Medicine labels: Guidance on TGO 91 and TGO 92

This guidance is to help sponsors and manufacturers of medicines meet the Australian labelling requirements described in the new labelling Orders. There are different risks...
Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan – Third Japanese company begins COVID-19 vaccine trials

Japan’s KM Biologics Co said on Monday it had started a human trial for its COVID-19 vaccine, becoming the country’s third candidate to advance...
Australian regulatory action on breast implants and breast tissue expanders

Australia – New legislation to support medicine substitutions

New legislation has been passed to allow pharmacists to substitute a different medicine when a patient's usual medicine has been declared to be in...

Australia – TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines...

TGA has adopted guidance developed by the Access Consortium - a coalition of regulatory authorities from Australia, Canada, Singapore, Switzerland and the United Kingdom. The guidance lays...

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