The guidance published by the Therapeutic Goods Administration (TGA) on August 2020, gives direction about setting up the summary page for Consumer Medicine Data (CMI) documents. The document is aimed
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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) who are new, relocated, or resuming, shall apply for and
read more...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, and the medical devices that manufacturers and importers are required
read more...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 medicine drug review, a relatively high technical and professional review is
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 able to be supplied in accordance with a prescription.
Regulations (5) and
read more...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 therapeutic goods advertising measures within two years from the commencement
read more...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 2020. This guidance replaces archived ARGCM V8.0 Part C: Evaluation
read more...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 plan in strengthening adverse event monitoring system for medical devices
read more...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 for Drugs to promote the correct understanding, implementation, and evaluation
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