中文

News & Events

Drug Registration Environment in China and dMed / Clinipace Regulatory Affairs & Strategy Services
2021-07-26Return>>

The drug regulatory environment and regulatory supporting measures (including laws, regulations, rules, and guidance, etc.) in China have undergone historic changes in the past decade. Since 2015, the China health authority (HA) has initiated reforms to drug review and approval system. With the implementation of the new edition of Drug Administration Law and Vaccine Administration Law on December 1, 2019, and then the new edition of Drug Registration Regulations (DRR) on July 1, 2020, China HA continues to promote the modernization of the review system and review capacity, promote scientific review, improve review quality and efficiency, and accelerate the pace for new drug R&D and marketing.

Innovation is the source of power to promote the high-quality development of drugs. The Drug Registration Regulations (DRR), based on domestic clinical needs and referring to international experience, has established four accelerated marketing procedures: Special Review and Approval, Breakthrough Therapy Drugs, Conditional Approval and Priority Review and Approval, so as to accelerate the marketing of drugs that are urgently needed in clinical practice, with outstanding clinical value or are urgently needed in public health. Center for Drug Evaluation (CDE) also strengthens the communication and exchanges with applicants. CDE communication meetings can be applied at the key stages of drug development (before IND, EOP2, etc.), or for major safety issues encountered during clinical trials, etc. In addition, NMPA has been improving the drug administration system in line with international standards. In 2017, China HA joined ICH and was elected as a member of ICH Management Committee in 2018, accelerates the construction of guideline system and actively pushes for transformation and implementation of ICH guidelines.

Based on data from CDE 2020 Review Report, in 2020, CDE reviewed and approved 1435 IND applications, showing an increase of 54.97% compared with 2019; reviewed and approved 208 NDA applications, showing an increase of 26.83% compared with 2019; CDE completed 1136 applications for quality and efficacy consistency evaluation of generic drugs (a campaign to improve the quality of generic drugs), showing an increase of 103.22% compared with 2019. In 2020, 94.48% of the total registration applications completed the review and approval within the officially specified time limit; especially, for those overseas new drugs that are urgently needed, the review and approval were completed 100% within the specified time limit.

Our Regulatory Affairs & Strategy team is comprised of experienced RA members, most of whom have many years’ RA experience with globalized pharmaceutical companies, are very familiar with China registration regulations, guideline and guidance of CMC, non-clinical and clinical requirements, and are excellent at communications with both domestic and oversea clients. Our RA team are especially experienced in Pre-IND/IND, Pre-NDA/NDA applications for innovative new drugs (both chemical and biological). For example, on average, we have 3 interactions (consultation meeting or IND submissions) each month with CDE. We can support clients to establish the optimal development plan, registration strategy to accelerate their marketing process.


China:
298 Xiangke Road, 3/F, 301-305, Pudong New District, Shanghai 201210
Tel: +86 21 5090 0085 Fax: +86 21 6875 5515

United States:
3800 Paramount Pkwy, Suite 100 Morrisville, NC 27560
Tel: +1 919-224-8800

沪ICP备16041651号 Copyright © 2016-2021 dMed All Rights Reserved
沪公网安备 31011502005403号