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 …

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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 …

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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 …

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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 …

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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 …

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NPRA Malaysia Announces Implementation of Pilot Project for Pharmaceutical Track and Trace for Vaccines

The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has announced their plan to develop a Pharmaceutical Track & Trace system that …

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Hong Kong Drug Office Updates Frequently Asked Questions’ Page

Hong Kong Drug Office has provided the latest set of frequently asked questions (FAQs) on their official website at the …

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Australia TGA Publishes Guidance on Standards for Biologicals for Labelling Requirements

The Therapeutic Goods Administration (TGA) Australia has published a new guidance on Therapeutic Goods Orders (TGO) 107 to provide a …

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Australia TGA Publishes Guidance on Standards for Biologicals

he Therapeutic Goods Administration (TGA) Australia has published a new guidance on Therapeutic Goods Orders (TGO) 109 to provide a …

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