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 …
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 …
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 …
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 …
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 …
Taiwan Issues Guidance on In-Vitro Companion Diagnostic Devices (CDx)
The Taiwan FDA issues on 16 July 2020 the guidance on in-vitro companion diagnostic devices (CDx), which are aimed to …