CDE of China Issues Guidelines for Drug Information Changes

The Center for Drug Evaluation (CDE) released the “Marketed Chemicals Pharmaceutical Changes Study Technical Guidelines (Trial)”, “Marketed Chemicals and Biological …

read more...

China Revises the Provisions for Lot Release of Biological Products

Pursuant to the new Vaccine Administration Law and the revised Drug Administration Law, the Provisions for Lot Release of Biological …

read more...

China’s NMPA Signs MoU on Regulatory Cooperation with Italian Medicines Agency

China’s NMPA signs MoU on regulatory cooperation of medicines, medical devices, cosmetics with Italian Ministry of Health, Italian Medicines Agency. …

read more...

China CDE Revised Procedures for Drug R&D and Technical Review Communication and Discussion with Applicant

China CDE has issued an updated version of “Administrative Measures for Drug R&D and Technical Review Communication and Discussion ” …

read more...

Q&A on Implementation of Chinese Pharmacopeia 2020

The Chinese Pharmacopoeia Commission has published a Q&A on the Implementation of 2020 Chinese Pharmacopeia on 30 September 2020. The …

read more...

NMPA issues a Circular on the Registration of Medical Devices for Urgent Clinical Needs

This circular, dated 29 October 2020, specifies measures related to the review and approval of medical devices for urgent clinical …

read more...

China NMPA rolls out Drug Information Traceability System for key drug products

On October 10, 2020, NMPA made an announcement in relation for Drug Information Traceability System for key drug products (Circular …

read more...

China Releases Technical Guidance for Using Real-World Evidence(RWE) to Support R&D and Regulatory Review of Pediatric Drugs (Interim)

The CDE has issued this guidance to assist researchers in understanding the application of real-world evidence in the R&D and …

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 …

read more...

More News