Singapore HSA revises guidance and technical documents

Singapore – Singapore approves new storage condition for Pfizer COVID-19 vaccine

The Health Sciences Authority (HSA) in Singapore has approved the new storage condition for the Pfizer-BioNTech COVID-19 vaccine to be stored at refrigerator temperature...

Asia – Asia-Pacific Roundup

PMDA sets out plan for accelerating medical devices access Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published details on how it plans to accelerate...
TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – Guidance on the management of GMP compliance signals for domestic and overseas...

The guidance outlines the Good Manufacturing Practice (GMP) compliance requirements (according to the Manufacturing Principles(link is external)) for manufacturing biologicals and medicines intended for supply in Australia and...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – India’s COVID-19 crisis could lead to global drug shortages

A terrifying and record-breaking wave of Covid-19 in India threatens to stall the country's economic recovery and send shockwaves through several important global industries. Asia's third...

China – China’s Sinopharm given WHO emergency use listing for COVID-19 vaccine

The WHO has announced that it had listed the Sinopharm COVID-19 vaccine for emergency use, saying in a statement that the decision gives the ‘green light’...
Chinese NMPA publishes UDI system rules for medical device registrants

China – Company in China developing inhaled COVID-19 vaccine

China’s CanSino Biologics will start clinical trials for a Covid-19 vaccine administered through inhalation next week, the company’s co-founder and Chief Executive Xuefeng...

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...

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