Throughout these years, while the Chinese authorities are striving to reduce people’s medical costs, they are also providing favorable policies to stimulate innovation in the pharmaceutical industry. On March 31, 2023, the Center for Drug Evaluation (“CDE”) under the PRC National Medical Products Administration (“NMPA”) issued the Work Specification for Accelerating the Review of Innovative Drug Marketing Authorization Applications (Trial) (“Work Specification”) with immediate effect on the same day. The Work Specification is designed to expedite the review workflow of qualified innovative drug marketing applications through early involvement, research and review coupling, rolling submission, and prior inspection and testing.
Applicable Scope of the Work Specification
The Work Specification automatically applies to type 1 innovative drugs (including both chemical drugs and biologicals) already included in the breakthrough therapy designation procedure,1 and will be applicable to type 1 innovative drugs for pediatrics, and rare disease therapies upon separate application.
The applicant, following the exploratory clinical trials, is able to conduct subsequent front-end communication, and review and approval in accordance with the Work Specification. With respect to the innovative drugs intended for the conditional approval procedure, the Work Specification is also applicable before the completion of the exploratory clinical trials.
Continuous Optimization of the Review Workflow
The Work Specification specifies the workflow and some of the timelines to enhance the efficiency of review and approval. The workflow covers the spectrum of early involvement, acceptance and task allocation, inspection and verification, professional review, comprehensive review, audit and issuance, and the production of documents delivered to the NMPA. Key aspects are summarized below:
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Early involvement: innovative drugs included in the Work Specification are entitled to communications with the CDE at each R&D stage, and if determined, the communications will be held within 30 days. CDE will also help with a preliminary review of the marketing authorization application materials for the applicants. In particular, the applicant is required to submit a preliminary communication application before the marketing authorization application to discuss whether the existing research materials are satisfactory, so as to avoid the shortcomings among different professions that may affect the marketing application. More importantly, before the marketing authorization application, the applicant can negotiate and reach a consensus with the CDE over the plan for further submission of documents (e.g., updating long-term efficacy and safety data) according to the R&D status of the drug. In this way, the applicant is able to submit relevant documents on a rolling basis as agreed upon by both parties throughout the substantial review process.
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Acceptance and task allocation: according to the Work Specification, the CDE will get involved even prior to the application process, so as to address issues as early as possible. It is said that drugs included in the Work Specification will be specially marked in the review system, so that smoothness of relevant procedures can be guaranteed.
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Inspection and verification: generally speaking, the inspection for the innovative drugs included in the Work Specification shall be prioritized pursuant to the priority review procedure and the Work Procedures for Initiating Drug Registration and Inspection (Trial) which came into effect on January 1, 2022.
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Professional review: as discussed above, application materials for technical review can be submitted and accepted on a rolling basis. Moreover, during the technical review process, the Work Specification provides that an expert session can be held in priority within 10 days wherever necessary.
According to the Work Specification, at the same time of the marketing authorization application, applications shall also apply for the priority review procedure, in which the time limit for the review will be reduced from 200 days to 130 days.
Next steps
The release of the Work Specification implies a significant acceleration in the progress toward the approval and marketing of innovative drugs for pediatrics, rare diseases, and those incorporated into the breakthrough therapy drug program. Indeed, over recent years, the CDE has issued successive policies on the optimization of review and approval, including for example, the Opinions on Reforming Review and Approval Process for Drugs and Medical Devices concerning registration applications and the Announcement for Adjusting the Review and Approval of Drug Clinical Trials on clinical trial reviews. Given the robust policy support, China's new drug review and approval have been speeding up and the launch of innovative drug products has been expedited recently. Though the official data for 2022 has not been released yet, according to the CDE report, in 2021, the NMPA reviewed and approved 47 innovative drugs, hitting a record high.2 In the future, it is signaled that more and more favorable procedures will be released to stimulate the drug marketing, and it is advisable to have a closer monitor on the regulatory progress.
Authored by Lu Zhou, Jessie Xie, and Olivia Xie.
References
1 Breakthrough therapy designation procedure is one of the four fast-track registration regimes for the application for marketing authorization of drugs. The others are conditional approval procedure, priority review and approval procedure, and special review and approval procedure.
