What’s New for Drug Registration in China? Class I or Class V.
Co-organized by Tigermed and Swiss Chinese Chamber of Commerce (SCCC)
To support the implementation of the Drug Registration Regulation and to facilitate the successful drug registration in China, we are very happy to share and discuss the great improvement it brings to the industry.
On March 30, 2020, the revised Drug Registration Regulation was issued by the State Administration for Marketing Regulation and will be put into effect from July 1, 2020. The revised regulation is focused on the acceleration of clinical trial approval, implementing a risk-based approach in clinical development, protecting trial subjects’ rights, and overall enhancing the in-process administration, from filing, review, and risk-based site inspections till suspension and even termination of clinical trials. Also, we will touch on the liabilities throughout drug lifecycle.
Encouragingly, the revised Drug Registration Regulation has optimized the overall review and approval framework, systems, principles, and procedures. It becomes another important milestone to foster the fast growth of the pharmaceutical industry and to further satisfy the unmet medical needs of the public in China.
Date & Time
July 2, 2020 (Thursday) / 11:00 – 12:00am Europe Time. / 5:00 – 6:00pm China Time
Maggie Chang, Vice President of Drug Regulatory Policy, Tigermed.
Maggie joined Tigermed in 2013, after she worked with RDPAC (R&D-based Pharmaceutical Association Committee) for 5 years as director，devoted in the drug regulatory policy advocacy area. She also had 15 year experience in dept. of drug registration and clinical trial in China subsidiaries of multinational pharmaceutical companies, e.g. Schering AG, SmithKline Beecham and Schering-Plough.
- Drug Administration Law was made the 2nd revision since 2001 and put into force since December 2019, the remarkable achievements of the drug review and registration reform are now legislated in encourage drug R&D.
- Following the current version of Drug Registration Regulation valid since 2007, the revision with fundamental improvement will become valid from the 1st of July 2020.
- Expedited approval with four procedures will shorten the drug lag, they are breakthrough therapy designation, conditional approval, priority review and approval, and special approval, in which the scope of application, procedure, support policy and other requirements for each procedure are specified.
- More than 50 working documents and guidelines are on the way to come to support the enforcement of the Drug Administration Law and the Drug Registration Regulations.
- The implementation of the Marketing Authorization Holder system sets the new criteria to exam the NDA applicant for becoming the MAH.
- It is a big decision to make to file as Category I or Category V for the innovative drugs from oversea.