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 …
China Releases Working Procedures for Breakthrough Therapy Drugs, Conditional Approval and Priority Review
In order to support the implementation of the new Regulations of Drug Registrations, The National Medical Products Administration(NMPA) of China …
Malaysia Issues Document for GMP Inspections on Traditional Medicines, Health Supplements and Cosmetics Manufacturers
On 01 July 2020, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia released a guidance document for good manufacturing practice(GMP) …
China’s CDE Issues Guideline for Risk Management of Clinical Trials
Center for Drug Evaluation (CDE) of China published a guideline document pertaining to “Clinical Trial Safety Information Evaluation and Management …
NMPA Issues Rules for Development Safety Update Reports(DSUR)
On 01 July 2020, China’s NMPA’s Center for Drug Evaluation(CDE) has issued administrative rules titled “Management Guidance/Standard for Development Safety …