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
Regulatory News
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
read more...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 general medical device listing applications with established support on proven
read more...Taiwan Guideline for Basic Considerations for Real World Evidence for Drug Development
The use of Real-world Data (RWD) to produce appropriate Real-world Evidence (RWE) as a basis or supplement for drug efficacy or safety data is in the ascendant.
The Food and Drug
read more...Malaysia Implements Evaluation of Bioequivalence (BE) Examination Requirements
On 2 July 2020, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has agreed to the implementation evaluation of bioequivalence (BE) study screening requirements as per instruction letter : NPRA.600-1
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