Hong Kong regulator will continue to recognize South Korean approvals

China – Experts suggest new method for assessing imported generic drugs in China

According to researchers, a newly developed strategy could improve the quality of generic drugs by assessing process control and process risk. In addition to...
Principe des 3R : avancées de la Commission européenne de Pharmacopée ces dix dernières années

China – Clinical evaluation authority, plus guidelines for animal testing studies

The National Medical Products Administration (NMPA), China’s medical device market regulator, has revealed plans to set up a technical division focused on clinical evaluation...

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...

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