Pharmaceutical enterprises enthusiastically put forward amendments to the measures for the administration of drug registration

2013-11-22 source: consultation draft of the amendment (Draft) to the measures for the administration of drug registration issued by CFDA by the editor of pharmaceutical economic news, which has attracted wide attention and hot discussion in the industry From the beginning of this issue, we will invite people from the government, associations, societies and business circles to discuss this issue, and collect and analyze relevant suggestions for reference by all parties concerned Please pay attention to them Recently, the State Food and Drug Administration (CFDA) issued a draft for comments on the amendment (Draft) to the measures for the administration of drug registration (hereinafter referred to as the draft for comments), which preliminarily amended the relevant provisions of the measures for the administration of drug registration According to the reporter's observation, this revision mainly added the provisions to adapt to and encourage drug innovation, emphasized the connection with patent law, improved the relevant provisions of the monitoring period management, and adjusted the requirements for the on-site inspection procedures for the registration and production of generic drugs From the interview, the draft has attracted great attention in the industry In general, entrepreneurs and relevant scientific research experts generally agree with the contents of the draft, and believe that on the one hand, CFDA The regulatory work has been continuously connected with the international regulatory concept and system, which is more open and scientific, such as the revision notes issued together with the draft for comments, as well as the adoption of some reasonable voice of the enterprise; on the other hand, the incentive policies for drug innovation have been more substantially adjusted However, there are still fierce discussions among enterprises and industries on the "one report, two batches" of generic drugs and the adjustment of on-site inspection procedures for generic drugs Encourage innovation and speed up "the scientific research community is very concerned about the draft Generally speaking, I feel that the regulatory authorities are closely following the overall situation of the country's political and economic development On the basis of adhering to scientific supervision, they are constantly optimizing regulatory methods I think the draft has more positive impact on the whole." Fan Xiaohui, deputy director of the Institute of pharmaceutical information of Zhejiang University who once worked for FDA, said in an interview with this newspaper Yu Chunna, director of registration department of green leaf Pharmaceutical Group, a leading R & D company in China, said that in general, the draft has not changed significantly Green leaf is most concerned about the newly added provisions on adapting to and encouraging new drug innovation, as well as the fact that the actual review time of drug review center is quite different from that of the draft The revised Drug Registration How to solve the problem of review overtime The reporter learned that there are three aspects to encourage innovation: first, the draft stressed the connection with the patent law, deleted the relevant provisions that the imitation of drugs that have not been applied for patent in the past must be declared within two years before the patent expires; second, revised and improved the relevant provisions of the new drug monitoring period, and stressed that during the new drug monitoring period, the State Administration will no longer Accept the registration application of the same variety, dosage form change, imported drugs, etc., but for those who have accepted the registration application of other applicants, they can continue to handle the application in accordance with the drug registration application and approval procedures; third, add new clauses allowing the change of applicants and technology during the clinical period, etc "The revision of these provisions will play an important role in speeding up the development and marketing of generic drugs in China and enhancing the accessibility of drugs To some extent, it will continue to gradually expand the international vision of Chinese new drug innovation and the global strategic vision of enterprises." This is the analysis of the R & D personnel of a pharmaceutical enterprise in Guangdong For the revision of the monitoring period, the person analyzed that according to the current drug research and development situation, it is normal for multiple enterprises to declare a product at the same time If the new provisions are implemented, it means that the pressure of enterprise competition will be more prominent, but it is good for full competition and improving drug quality Enterprises actively put forward the relevant contents of drug registration management, which is a major issue related to the innovation of Chinese medicine and the improvement of drug R & D capability and achievements of enterprises Therefore, the draft for comments has also attracted great attention of the enterprise community, and actively put forward the revision opinions and suggestions As far as the reporter's interview is concerned, the revision of the relevant provisions of the approval of generic drugs is a hot topic in the current industry discussion: first, the draft will adjust the on-site inspection of generic drugs production to the completion of clinical trials and technical review, before the listing license; second, the way of "one report and two batches" will be used in the application of generic drugs In the aspect of on-site inspection, CFDA emphasizes that after the link adjustment, it is more effective to ensure the quality of generic drugs, reduce the resource investment of generic drug approval enterprises, and improve the efficiency and quality of on-site inspection, but enterprises generally worry that the application will be more complex; the terms of "one report and two batches" are generally lower than the industry's expectation Green leaf group has completed the written materials of relevant opinions in the draft for comments and is ready to submit them to relevant departments In terms of specific contents, the company proposes to clarify the rapid approval process of generic drugs and the list of generic drugs entering the rapid approval channel regularly published by the state in the draft for comments; to include special preparations such as liposomes, microspheres, microemulsion, etc into the innovative drug process, make detailed regulations and shorten the review time limit of special preparations; and to clearly declare the non processing of generic drugs respectively The procedures of prescription drugs, prescription drugs conversion to over-the-counter drugs, prescription drugs conversion to double cross varieties, application and imitation of double cross varieties; the fourth is to increase the penalties for the failure of drug supervision and administration departments to complete the acceptance, review, approval and other work within the prescribed time limit (Yang Junjian, Ma Fei)