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
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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
read more...MFDS of Korea Changes the Re-examination System To One Based on Product Life Cycle
MFDS Press Release on 16 July 2020 :
To improve the safety management system of post-approval marketed drugs, the current Post-Marketing Safety System based on the ‘Re-Examination System’ (every 4 –
read more...China Adopts ICH E2C (R2): Periodic Benefit-Risk Evaluation Report (PBRER)
In order to strengthen the management of the life cycle of drugs and promote the international integration of drug regulatory technical standards, the National Medical Products Administration (NMPA) has announced
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