India – India lowers bar for approval of COVID-19 vaccines already authorized overseas
India’s Central Drugs Standard Control Organization (CDSCO) has relaxed the requirements for the restricted-use emergency authorization of COVID-19 vaccines that are already on the...
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...
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...
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’...
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...
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...