Asia – Asia-Pacific Roundup: India okays a handful of FDCs as long saga continues

India’s Central Drugs Standard Control Organization (CDSCO) has deemed 31 fixed-dose combinations (FDCs) as rational some 14 years after India ordered the withdrawal of 294 FDCs...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – Pharmaceutical supply disruptions predicted in India

The pharmaceutical industry in Tamil Nadu foresees the months ahead in 2021 will be critical for the production and supply of pharmaceuticals because the...
TGA Updates Guidance on the Testing of Biological Medicines

Australia – TGA international engagement strategy 2021-2025

The Therapeutic Goods Administration (TGA), as part of the Australian Department of Health, supports the Department's strategic priorities for an affordable, accessible, efficient and...

Asia – Asia-Pacific Roundup: Malaysia publishes guidance on manufacturing cell and gene therapies

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has released guidance about cell and gene therapy manufacturing facilities. The guidance describes the process for setting up...
Home-grown colorectal cancer drug approved in China

China – China announces new guidelines for oncology drugmakers

The US has long been the leader in research and development in oncology, but homegrown Chinese drugmakers have jumped one hurdle after another in...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

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 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...

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