Singapore HSA Shares Statistic on HSA’s Mean Screening Time and Applicant’s Mean Screening Response Time For New Application and Major variation Applications
HSA strives to complete the screening of the new and major variation applications in the shortest possible time. For the …
Access Generic Medicines Work-Sharing Initiative
The Therapeutic Goods Administration (TGA) Australia has released further information on the Generic Medicines Work-Sharing Initiative. It is an innovative …
China NMPA Extends Drug Submission Time for Supplementing Materials
On October 14th, China’s National Medical Products Administration (NMPA) announced an extra 80 to 160 days extension for the submission …
Hong Kong DOH Updates the List of Refence Countries for Registration of Pharmaceutical Products
Hong Kong’s Pharmacy and Poisons Board reviewed the requirements of the list of reference countries for the registration of pharmaceutical …
Thailand FDA Implements GMP Clearance Temporary Process During COVID-19 Pandemic
The State Drug Regulatory Authorities overseas, responsible for the assessment of manufacturing standards according to GMP principle, have postponed the …
Vietnam Ministry of Health Updates Guidance Report of Bioavailability/Bioequivalence for Drug Registration
This Circular is issued on 5 Sept 2022, effective on 1 Nov 2022, and replaced the current guideline Circular 08-2010/TT-BYT …
Vietnam Ministry of Health Updates Guideline on Registration of Drug and Medicinal Materials
Circular 08/2022/TT-BYT (Circular stipulating the registration of DRUG, Medicinal materials) was issued on 5th September 2022 and will be implemented …
Singapore HSA Updates Guidance on Therapeutic Product Registration
The Health Sciences Authority (HSA) Singapore has published the updated guidance document on the regulatory processes and requirements for therapeutic …
Hong Kong Drug Office Publishes Frequently Asked Questions on Bioavailability and Bioequivalence Studies for Pharmaceutical Drugs
Hong Kong Drug Office has published a set of frequently asked questions on Phase 2 requirements of bioavailability (BA) and …
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