Understanding China Pharmaceutical Regulations Webinar Series
China's pharmaceutical industry is experiencing rapid development these years. The growth can't be achieved without the incentive policies introduced by the Chinese government. The government has been working to improve the pharmaceutical regulatory environment and ensure that medicines are easily accessible for Chinese patients.
Given the growing concern of the Chinese people for health and the huge consumption potential of the Chinese pharmaceutical market, more and more international pharmaceutical companies are targeting this market.
To help relevant industry enterprises and individuals understand the current pharmaceutical regulations and the future trend in China, the BaiPharm team under ChemLinked plans to launch this webinar series in the upcoming months of 2021.
There will be at least 10 topics, covering China's drug regulatory authorities, major laws & regulations, DMF system, MAH rules, drug registration classifications, new drugs, generic drugs, clinical requirements, change management, pharmacovigilance, etc. Topics could be revised or added based on the needs of all members. Welcome to drop your feedback to email@example.com.
Session 2: Chinese Drug Legislative Framework
China joined the ICH (International Council for Harmonisation Technical Requirements for Pharmaceuticals for Human Use) in 2017. Since then, the country has been reforming its pharmaceutical regulatory system, including establishing the MAH (marketing authorization holder) system to implement ICH's standards and guidelines. These changes significantly impact on the domestic and foreign pharmaceutical companies' registration strategy and approach to the NMPA. In the second session of the webinar series, our guest speaker Mrs. Xia will introduce China's drug legislative framework and elaborate on specific regulations.