China NMPA Extends Drug Submission Time for Supplementing Materials
On October 14th, China’s National Medical Products Administration (NMPA) announced an extra 80 to 160 days extension for the submission …
China NMPA Implements Drug eCTD Submission
On 30 September 2021, China NMPA issued an announcement No. 119 of 2021 regarding implementation of drug eCTD submission. From December 29, 2021, applications for …
China Issues New Pharmacovigilance Quality Management Practice/Standards
On 7th May 2021, China’s National Medical Products Administration issued a new Pharmacovigilance Quality Management Practice/Standards (ie. China GvP) to …
China NMPA Establishes Patent Linkage Registration Platform
On May 18, 2021, China’s Center for Drug Evaluation of National Medical Products Administration (NMPA) issued the “Notice on the public testing …
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 …
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 …
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. …
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 ” …
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 …
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