Medical network - on February 27, recently, total bureau of national food and drug supervision and administration of the drug approval center "drug review symposium", listen to experts in the field of medicine, enterprises and research and development institutions on behalf of the views and Suggestions. Reporter has learned that at the meeting, in 2016, the administration of human medicinal center to carry out the deployment, has realized the basic digest inventory backlog, 3779 host parent review task, send bureau review task 12068, completed a review of enterprise complement data varieties 943, basically achieved 44 files and administration of the party group of the state council determine the solve the backlog of work target for 2016. 

 

In addition, human medicinal center for some 2016 has significant clinical value of innovative medicine, patent expired medicine, domestic first copy, etc to speed up the priority review, published throughout the year 12 group of a total of 193 varieties of priority review directory. First innovative Chinese medicine treatment of influenza, such as golden flower clear sense of particles, the original import from oral drug interferon cure hepatitis c dara he wei, the first copy anti-aids drugs tenofovir fumaric acid two pyrazole cefuroxime ester pieces and passed the review are preferred. In particular, the original import type treatment of systemic juvenile idiopathic arthritis drugs approved quickly, solves our country children's long-term clinical problem of no cure idiopathic arthritis. 

 

Mr Sun, vice minister of the state food and drug supervision and management of the administration, points out that so far, our country has experienced three times in the history of drug registration backlog of peak, and the reform of our goal is to further promote drug approval for examination and approval, and ensure the public safety, promote healthy development of the pharmaceutical industry. In order to ensure the work smoothly, administration carried out the reform of the drug registration classification, drug marketing authorisation holder system pilot consistency and the quality of generic drugs and curative effect evaluation and so on a series of work, achieved positive results. Human medicinal center adhere to the backlog, build system, severely, effectively promote the reform. 

 

"2017 will strengthen overall drug approval for examination and approval work, deepen the reform of the mechanism of drug approval system." Mr Sun, one is to maintain, to ensure an all-round victory in the 2017 solve the backlog Armageddon, review of implementation according to the time limit; Ready to play simple clinical and BE put on record of generic drugs clinical approval after the production, after the completion of clinical verification withdraw reapply listed varieties of batch production, the quality of generic drugs and curative effect evaluation and process consistency for the record of the supplement after preparation; Second, focus on reform, around the "pipes" pushing the reconstruction for examination and approval of drug approval system, the implementation of the "standard guide in the former, the communication in the review of decisions in the" review of ideas, actively promote the establishment of the review of drug approval for examination and approval of technical system, implementation based on the review, on-site inspection and product inspection for the technical support for examination and approval of the review mechanism, optimize processes, improve efficiency; 3 it is to accelerate the quality of generic drugs and curative effect evaluation of consistency, expand the clinical resources, build system of China's "Orange Book"; Four is ready to process check, establish archives work such as drug varieties, sum up experience, improve the policies; Five is to establish drug electronic universal technical documentation (eCTD) system. 

 

Administration of state food and drug supervision and administration of drug approval, director of the center for Xu Jiaji also said that in 2017 human medicinal center to strengthen communication and close cooperation with medicine, provide more powerful research and development for the enterprise production guidance and services, to speed up the enhance the level of drug quality and safety, starting from the overall situation, the overall situation of reform of supervision, adhere to the concept of innovation and development, supervision, review in service, earnestly to do a good job of drug approval. 

 

Experts, industry representatives attending the meeting agreed that drug approval for examination and approval system reform is a reasonably good thing, a series of policies and measures of the reform is gradually to the ground, the review speed and obviously improve quality, innovative drugs and drugs for urgent clinical needs priority review, open the channels of communication, the communication system the industry environment tend to be more reasonable, fair and specification, to comprehensively enhance the level of China's pharmaceutical and drug quality, and better meet the public safety is of great significance to effectively. We suggest, to further deepen the reform, perfecting the evaluation standards and guiding principles, to strengthen the construction of the review team and the ability to review and optimize simplify the review process, to create a stable policy environment.