CDE (Center for Drug Evaluation, CFDA) issued 2016 Drug Review Annual Report on March 17, 2017. The introduction of this report was very interesting itself: CDE had issued a review report one week earlier, but emergently withdrew it as some parts involved leaking of the commercial interests of some applicants. The present review report formally issued is a document the pharmaceutical product R&D, registration and production personnel are very concerned about. CDE does not only introduce the data and trend analysis of review of various pharmaceutical products in 2016, but also generally introduce the work to do in 2017 in the last part. The original text is as follows: firstly, further solve the pharmaceutical product review backlog to make sure the solution of the registration application backlog in the year, and achieve review according to the specified deadline in 2018; secondly, center on improving review quality, encouraging innovation, increasing review transparency, and continuing to deepen, refine and achieve priority review, communication, project management, indication team, expert consulting, information disclosure, and filing review system, etc.; thirdly, accelerate the establishment and improvement of the review quality control system, technical guideline system, and compliance management system; fourthly, accelerate the pharmaceutical product production process registration and checking, establish the process registration platform, introduce the process change guidelines, and regulate the process change management; fifthly, create pharmaceutical product variety files, and establish and improve databases containing pharmaceutical product processes, prescriptions, packaging materials of raw materials and excipients, quality standards, package inserts, safety information after marketing, and production process changes, etc.; sixthly, establish the pharmaceutical product Electronic Common Technical Document (eCTD) system and strive to receive chemical generic applications and conduct review according to eCTD requirements by the year end; seventhly, further optimize the internal organizations, improve the scientific management level, be strict with the review personnel management, strengthen confidential system construction and supervision and management, and optimize the career development system of reviewers.
The above closing remarks can be said to be highly summarized and refined, but they raise clear requirements for the pharmaceutical product registration and production management in 2017 and even the future work in the next years. Here I take the liberty of analyzing and interpreting the above policy signals based on my own perception to present the followings to the readers.
Firstly, further solve the pharmaceutical product review backlog to make sure the solution of the registration application backlog in the year, and achieve review according to the specified deadline in 2018.
Policy analysis: The main reason why the CDE has been much criticized by the pharmaceutical industry is the long-term backlog of the pharmaceutical product registration applications. This work has gained significant attention and progress improvement since the pharmaceutical product review system reform. If the solution of the review backlog issue in 2018 mentioned in the review report refers to solution by the end of 2018, this will mean that CDE should complete the review of the varieties having been applied and those newly applied in 2 years, meaning that CDE will continue to increase the recruitment and construction of the review force. The pharmaceutical industry needs to pay more attention to the strong personnel in own R&D and registration departments to avoid them from poaching by CDE, resulting in passiveness in own work.
Secondly, center on improving review quality, encouraging innovation, increasing review transparency, and continuing to deepen, refine and achieve priority review, communication, project management, indication team, expert consulting, information disclosure, and filing review system, etc.
Policy analysis: All the above work has been in progress, seen from the work progress of CDE in last year. Pharmaceutical enterprises shall do the following work in response to the a...
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