REPORT

China Drug Evaluation Report 2020-Reform of Drug Review & Approval System

by Heng Du
Aug 27, 2021

On June 21, 2021, the National Medical Products Administration (NMPA), to which the Center for Drug Evaluation (CDE) is affiliated, issued the China Drug Evaluation Report 2020.1 

This article collects key information from the report to inform global pharmaceutical companies of the drug approvals in China last year and the approval tendency in the past few years.

Part 1China Drug Evaluation Report 2020-Critical Numbers

Part 2China Drug Evaluation Report 2020-Disapproval Reasons

The following passage is Part 3 of the article.

6. Advancing the Reform of Drug Review & Approval System

6.1 Expediting the Review of Overseas New Drugs in Urgent Clinical Needs

Based on the comments from the expert team and the public, CDE has selected a total of 74 overseas new drugs urgently needed in China's clinical settings. The drugs will enjoy China's policy support, such as expedited programs for marketing authorization.

You can access to the English information of the overseas drugs urgently needed in China in BaiPharm Database.


6.2 Accelerating Consistency Evaluation of Generic Drugs

Firstly, while making progress in the consistency evaluation for oral solid dosage forms, CDE vigorously promotes the work for injections. The regulator launched the consistency evaluation work for 620 injections in last May and finished the reviews for these products in less than 5 months.

Secondly, CDE will continue to standardize the selection process of Referenced Listed Drugs (RLDs). CDE started selecting RLDs in Aug. 2017 and has published 44 batches of these drugs. ChemLinked will soon upload the English translations of the RLD lists to BaiPharm Database.

Thirdly, CDE will enhance information transparency and training for the industry and the public. In July 2020, CDE held a webinar on the technical details of consistency evaluation of generic injections. CDE will hold more public seminars to inform the industry of technical requirements for consistency evaluation and requisite documents for drugs applying to become RLDs.  

Fourthly, CDE will step up the work of putting the bioequivalence tests on file. In 2020, the filing platform for chemical drugs bioequivalence test has collected 627 records and the filing platform for RLD bioequivalence test has collected 292.


6.3 Pursuing Risk Management During Clinical Trial

Facing the COVID-19 pandemic, CDE established a mechanism for applicants to report the clinical trial progress, and standardized the relevant work procedure and technical requirements.

Thanks to the special review procedure, the clinical trial applications (CTA) for 15 vaccines, 16 biological products, 6 chemical drugs and 2 TCMs were approved in 2020. Besides, CDE completed 195 reports on the emergency review of COVID-19 vaccines, the progress of the clinical trials for anti-coronavirus drugs, and security check.

 

6.4 Enhancing the Foundation of Drug Review Mechanism

Develop the quality management system

According to the Administrative Measures for Drug Registration, CDE has built a stronger connection between the review work and quality management of drugs.

Facing the severe pandemic, CDE staff members have been working to tackle risks from COVID-19 immediately, and carry out its annual survey to collect advice and comments from drug applicants.

Strengthen the digitalization of review and approval

CDE (website: www.cde.org.cn) has served 10,674 companies, with services covering drugs, drug substances (APIs), excipients and packaging materials. The online platform aims to ensure efficient communication with drug applicants.


If you need more information on China drug registration & approval, welcome to send an email to contact@chemlinked.com. The ChemLinked BaiPharm Team will answer you with expertise and pleasure.

Heng Du
ChemLinked Regulatory Analyst
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