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- China’s New Drug Approvals Again Hit Record High in 2024
During 2024, local regulator the National Medical Products Administration (NMPA) green-lit 83 new drugs (excluding Traditional Chinese Medicines), up 12% from 2023 and significantly more than the 50 novel medicines approved in the US in this same timeframe Source: PharmCube’s PharmaGO® database
- 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
- 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
- New Drug Approvals in China Reached Record High in 2023
n 2023, the first full year after the COVID-19 pandemic, the National Medical Products Administration (NMPA) set a new record by approving the highest number of new drugs in China in a single year
- China GVP: Lifecycle Pharmacovigilance and Patient Safety
In May 2021, the National Medical Products Administration (NMPA) in China issued an announcement about Good Pharmacovigilance Practice (NMPA Decree No 65 2021), hereafter referred to as GVP, the first pharmacovigilance guideline issued in accordance with China new Drug Administration Law of the People’s Republic of China
- 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
- Global Pharmaceutical Regulation Evolving and Modernizing to Protect . . .
A series of important policies enacted in the past five years by the NMPA is a particularly prominent model for reforming pharmaceutical regulations On May 10, 2021, the NMPA outlined their opinions on comprehensively consolidating China’s capabilities in regulations, with special emphasis on accelerating efforts to establish and improve a scientific and efficient system for pharmaceutical
- Evolving Policies and Use of RWE in Regulatory Decisions in China
The NMPA RWE Research Project is an important part of China’s strategy to promote innovation in the pharmaceutical industry, reduce the time and cost of drug research and development, and improve patient outcomes
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