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...Regulatory News
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
read more...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 provide a reference on device efficacy and safety for manufacturers
read more...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 has published interim regulatory decisions pertaining to drug conditional and
read more...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) inspections for non pharmaceutical category (health supplements, traditional medicines and
read more...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 Standards (Pilot)” (No. 5 in 2020). The guidance document which
read more...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 Update Report” (No. 7 of 2020).
The rules were established to
read more...