On Feb. 23, 2020, China's Center for Drug Evaluation (CDE) issued the Work Rules for the Disclosure of New Drugs' Technical Reports (Trial) 1. The document says, from Jun. 1, 2021, CDE will release the technical review reports and package inserts of all new drugs approved since Sept. 1, 2016. Innovative new drugs, improved new drugs, and imported original or improved drugs with overseas marketing authorization are the major types covered.
The document also indicates the template for technical review reports of marketing approval applications, including major points as listed below.
Table 1: Main Content of Report on Technical Reviews for Drug’s Marketing Approval Application
The rules say CDE will first send the technical review report to the applicant after granting marketing authorization. If the report involves business confidential information, the applicant shall replace the relevant information with "Business Confidential," highlight it in black, explain the reason, and send the feedback to CDE within 40 days of receiving the report. If the applicant is unable to give feedback in time for some reason, he/she may apply for an extension of the feedback time not exceeding 20 days. CDE will not disclose the relevant information if it verifies that the applicant's feedback is indeed related to the business confidential information. Otherwise, CDE will decide what information to disclose according to relevant business confidential protection regulations. Anyway, CDE shall reveal the new drug's technical review report within six months after marketing approval.
China's efforts to improve transparency in drug review and approval can trace back to Aug. 2015, when the State Council listed information transparency as one of the goals for reforming the review and approval system for drugs and medical devices2. The trial rules released this time made more specific requirements on sharing the information. They are expected to promote the standardization of drug evaluation work, guide applicants to develop and apply in an orderly manner, and urge pharmaceutical enterprises to ensure the quality control, safety, and efficacy of drugs.
Additionally, BaiPharm noticed that the policy only targeted technical reviews for new drugs, but CDE has mentioned it would extend the disclosure to other categories of medicines like generic drugs. The procedure is predicted to have a more extensive influence since the number of drugs requiring technical reviews continued to rise from 2016 to 2019, according to the 2019 China Center for Drug Evaluation Annual Report 3. The report shows that a total of 6,199 drug applications required technical reviews in 2019, accounting for 76.7% of all the applications.
