Regulation makes drug registration more efficient

The backlog of drug registration applications in China has gone through several times, which is one of the main problems in drug registration evaluation in China In this regard, Chen Guiliang, director of Shanghai drug review and verification center, gave a wonderful speech on April 14 at the 2017 (second) pharmaceutical industry innovation forum hosted by China Pharmaceutical Industry Research Institute and hosted by China Pharmaceutical Industry Information Center from the perspective of improving the standardization and pertinence of application materials Optimizing the format of application materials and implementing the CTD format, a large number of low-level drug registration applications in China every year take up a lot of review resources and form a serious backlog of registration, which also makes the State Food and Drug Administration (CFDA) feel the pressure and some high-level and standardized pharmaceutical enterprises complain Since 2015, CFDA has issued a number of policies, such as self inspection and verification of drug clinical trial data, generic drug consistency evaluation, etc., to solve the problem of registration backlog, speed up the review and improve the quality of review According to the data shown in the 2016 annual drug review report (hereinafter referred to as the report) released by the drug review center (CDE) of the State Food and drug administration, the number of registration applications that have completed the review has increased by 26% compared with that in 2015, and the number of registration applications waiting in line for review has also decreased from the peak of 22000 in September 2015 to nearly 8200, basically eliminating the registration backlog At the same time, the report also published the main problems in various registration applications Due to the research project design and implementation can not support the safety, effectiveness, quality controllability and other situations of the applied drugs, a total of 2139 cases were concluded as not approved; due to the research defects in various registration applications, the first round of review concluded 1654 cases as supplementary information Chen Guiliang pointed out that in the application of generic drugs, due to the large defects in quality standards and other research, and insufficient preliminary research, the gap with the evaluation requirements is particularly prominent In addition to the problems of the research design itself, the increasingly complex structure of the application data is the main reason for the difficulty in passing the review The English full name of CTD is common technical docu ment, which is a general technical document written by the International Coordinating Committee for the technical requirements of human drug registration (ICH), and also the internationally recognized format of drug registration document "The implementation of the CTD format is conducive to standardizing the application data format, improving the evaluation efficiency and the management level of registration application, and reducing the regulatory cost of the industry," Chen said In China, CTD format is gradually advancing In the CMC part of chemicals, CTD format has been used, but in other parts, the progress of the format is still slow CFDA attaches great importance to this, will further promote the application of CTD format in drug registration and declaration in China, and plans to use the ectd format by the end of 2017 "Take API as an example, analyze the key points of quality control Chen Guiliang also gave a vivid answer to the questions that pharmaceutical enterprises are concerned about how to carry out quality research according to the existing technical guidelines, and what are the concerns of CDE reviewers in the review process He pointed out that "some of China's technical guidelines are not sound, and for the part of China that has no relevant technical guidelines to refer to, quality research can be carried out according to the technical guidelines issued by ICH." In the technical review of APIs, Chen found that in terms of the integrity of quality control items, the properties and inspection items are often ignored or omitted; in terms of the pertinence and sufficiency of quality control items, CDE reviewers will pay attention to the identification of API isomers, out of limit impurities, stability tests, etc The CDE reviewers will veto the application for incomplete project information, which should be paid attention to in the research and development of pharmaceutical enterprises In the establishment of quality standards, Chen stressed the difference between quality research and quality standard drafting He pointed out that "quality research is a characterization research on all aspects affecting drug quality, among which the key quality attributes affecting drug quality, the key to drug standard formulation, and the important parameters for drug standard formulation research In the quality research, we need to think about and pay attention to which indicators should be selected to enter the quality standard of drugs, which detection methods should be used for these indicators, and what limits should be determined when using these methods! " Standardize the format of drug registration documents, clearly understand the technical guidelines, conduct more reasonable research, and make drug registration more efficient!