Taiwan Implements GMP/GDP for API Manufacturers
Taiwan FDA has announced that API manufacturers must 1) from 27 July 2020, API manufacturers (including those only for export) …
Thailand Issues Notices for Medical Devices Requiring Registration
Thailand Ministry of Public Health has issued a new notification on 16 July 2020 stating the classification of medical devices, …
Taiwan Publishes a Separate Standards of Review Fees for the Registration of Western Medicines
Standards or Review Fees for the Registration of Western Medicines Considering the increase in complexity and novelty of the western …
New Zealand Reclassifies All Codeine-Containing Medicines as Prescription Medicines
Medsafe will gazette this change on 5 November 2020. On this date, codeine, and codeine-containing combination products will only be …
Australia Accepts Recommendations from Review of the Reforms to the Therapeutic Goods Advertising Framework
In 2018, the Hon Greg Hunt MP, Minister for Health, committed to a review of the impact of the new …
Australia TGA Updates the Guidelines for Applications for New Substances in Listed Medicines
TGA has issued an updated version 2.0 Australian regulatory guidelines for Applications for New Substances in Listed Medicines in August …
China Publishes Policy paper on Five-Year Plan to Strengthen Adverse Event Monitoring System
Effective from 30 July 2020 onward, the National Medical Products Administration(NMPA) of China released a policy paper on its five-year …
China CDE Releases a Guideline on Non-Inferiority Clinical Trials for Drugs
Effective from 24 July 2020 onward, the Center for Drug Evaluation(CDE) of China releases a guideline on Non-Inferiority Clinical Trials …
Hong Kong Continues Trial Scheme for Expedited Approval of Class II/III/IV Medical Devices
The Medical Device Division (MDD) will continue the trial scheme to streamline the application and approval process of Class II/III/IV …