FDA PH Issues Guidelines on the Publishing of Package Insert and Patient Information Leaflet of Registered Drug Products in the Food and Drug Administration (FDA) Verification Portal System
Guidelines: A. Approved PI and PIL of all registered drug products shall be published by the FDA in the Verification …
Vietnam MoH Issues Circular 41/2023/TT-BTC on Payment in Field of Pharmaceuticals and Cosmetics
On June 12, 2023, the Minister of Finance issued Circular 41/2023/TT-BTC on the rate, collection, payment, management and use in …
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 …
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 …
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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