The China “Provisions for Drug Registration” (Decree No. 27, short for “Provisions” afterwards) have been issued by the State Administration for Market Regulation (SAMR) and will be implemented on July 1, 2020. The new Provisions (link in Chinese) are the first revision in 13 years since October 2007.
The new Provisions update the previous drug registration regulations in China, and stay up-to-date with relevant international regulations in many aspects. They also cover issues that exist in practice but were not addressed by previous regulations.
Following the release of the new Provisions, accompanying standards and technical guidelines will be issued accordingly. Drug registration practices should follow the new Provisions when there are clear instructions; otherwise, existing regulations and requirements should prevail.
Below we at Acurit Medical Communications summarise the information from credible sources in Chinese to analyse this milestone and its impact on the sector. We especially highlight changes and trends compared to the old Provisions in 2007.
The main revisions of the new Provisions include:
Fully implement the Market Authorisation Holder system.
An applicant of a drug registration shall be a company or a medical research institution that can bear corresponding responsibilities. A regulatory framework of medicine quality assurance should be established to ensure safety, quality and efficacy of the medicines on the marketplace. A MAH shall manage a medicine throughout its life cycle, as well as conduct post-marketing studies.
Optimise assessment and approval processes.
The National Medical Products Administration (NMPA) manages drug registration in China. After receiving an application, the NMPA will carry out the assessment, inspection and verification at the same time, rather than one by one as were done previously. Four fast track approval pathways will be implemented. They are approval for breakthrough medicines, conditional approval, priority review and special approval. These pathways aim to improve the efficiency and timeliness of the registration process.
Several types of medicines are included in the fast track approval pathways. They are clinically and urgently needed drugs in short supply, paediatric medicines, medicines for rare diseases, medicines for major infectious diseases, urgently needed vaccines in disease prevention and control and innovative vaccines. Also, based on risk management, the NMPA will manage drug registration changes according to different classes.
Regulate medicines throughout their life cycles.
The NMPA will strengthen supervision of medicines’ research and development, registration and post-market surveillance. It will also increase the monitoring of clinical and non-clinical research organisations and set requirements on drug safety files. The Provisions stress streamline processes between drug registration and manufacturing authorisation to ensure good manufacturing practice (GMP). The Provisions will make transparent evaluation processes and decisions after inspection outcomes. Public surveillance and feedbacks are welcome.
Reinforce roles and responsibilities.
The Provisions require fine-tune of the roles and responsibilities of sponsors and regulators. Data fraudulence and plagiarism shall be punished to support the pharmaceutical industry and encourage innovation.
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Acurit Medical Communications Pty Ltd provides bilingual Chinese medical writing services for the pharmaceutical and health industries. We esp. focus on English Chinese literature reviews on nutrition and pharmaceuticals to support marketing claims, regulatory and R&D.
About the author:
Jing Jiang is a NAATI certified English-Mandarin interpreter and translator based in Melbourne, Australia. She commits to localizing and adapting the translated language for your target audience to ensure effective communication.