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- 2025 NMPA Approvals: China Clears Record Number of New Drugs
With the tremendous development of China’s innovative drug industry as backdrop, 2025 saw the number of new drugs approved by the National Medical Products Administration (NMPA)—the country’s regulatory authority—reach triple digits for the first time, an increase that was driven primarily by therapies developed domestically
- Appendix: New drugs approved by the NMPA in 2025
Comprehensive list of new drugs approved by China’s NMPA in 2025, including chemical and biologic therapies, targets, disease indications, and approval dates
- NMPA Plans to Start PIC S Accession Procedure in 2023
PIC S and NMPA are reported to be in close contact for further steps For the formal accession, it is most important that the NMPA’s inspection criteria are equivalent with PIC S’s The PIC S GMP regulatory compliance programme checklist is based on 11 components and 38 subcomponents comprising a total of 78 indicators
- China Focusing Innovation Through ICH Global Regulatory Vision
By translating and implementing ICH guidelines in the four years between June 2017 and DIA China 2021, NMPA has helped lead overall positive change to China’s drug regulatory system and thus to innovation in China’s drug review reform, promotion of China’s local drug development innovation, and enhancement of Chinese patients’ access to urgently needed drugs marketed abroad During the
- China’s NMPA Takes Action to Participate in PIC S
Since initiating the process of pre-admission to the Pharmaceutical Inspection Co-operation Scheme (PIC S) in September 2021, the National Medical Products Administration (NMPA) has been actively taking part in PIC S-related activities in preparation to become a PIC S participating authority
- NMPA Moves ICH E2 Forward in China - DIA Global Forum
Over the past two years, the Chinese National Medical Products Administration (NMPA) has aggressively implemented a series of ICH E2 guidances
- China’s Evolving Role: From Harmonization to Source of Innovative . . .
This integration has not only boosted international confidence in Chinese drug quality but also strengthened China’s voice in global rule-making through participation in 45 ICH working groups, and accelerated overseas expansion of China-originated drugs: Zanubrutinib and benvitimod obtained rapid back-to-back approvals from the NMPA and US
- New Drug Approvals in China in 2021 - DIA Global Forum
The number of new drug approvals in China set a new record high in 2021 A total of 61 new drugs were approved by the National Medical Products Administration (NMPA), up from 46 in 2020 “New drug” is defined in this article as new chemical drugs or new biological products approved for the first time in China, excluding any new indications, new dosage forms, or new combination of approved
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