Three arrows in a row to reform drug regulation

The drug administration law, which was deliberated and adopted at the 12th session of the 13th National People's Congress in August this year, will come into force on December 1 In order to establish a scientific and strict drug supervision and management system and ensure the effective implementation of the drug administration law, on September 30, the State Food and Drug Administration issued three copies of management measures for consultation: Measures for the administration of drug registration (Revised Draft for consultation), measures for the administration of drug production supervision (Revised Draft for consultation), measures for the administration of drug trade supervision (Draft for consultation) 》, ask for opinions from the society According to the opinions and suggestions of all parties, the State Food and Drug Administration revised and improved the three regulations, and again solicited opinions from the public through the legal information network of the Chinese government on October 15 According to the industry, the three drafts of the State Food and Drug Administration (SFDA) concerning the whole process supervision of drugs are milestone documents to promote the supply side structural reform of the pharmaceutical industry and realize the transformation of China from a big pharmaceutical country to a powerful pharmaceutical country After these three documents are issued, the survival and integration of the industry will be accelerated, so as to realize the transformation of China from a big pharmaceutical country to a powerful pharmaceutical country Medical Observer: Article 5 (drug registration category) of the administrative measures for drug registration (Revised Draft for comments) stipulates that the drug registration category shall be classified according to traditional Chinese medicine, chemical drugs and biological products The State Food and Drug Administration will organize to formulate and issue detailed classification and corresponding application data requirements for various drugs as required Excuse me, what are the reasons for the subdivision of drug registration categories? What is the impact of drug classification on drug registration? Yang Hua: the reasons for the refinement of drug registration categories are as follows: first, the original registration classification cannot be clearly defined in the actual application; second, the original registration classification does not clearly define the innovation degree of innovative drugs, especially the classification of traditional Chinese medicine In terms of clinical application value, the innovation degree of traditional Chinese medicine categories 1 to 6 is not necessarily significantly different Once the new drug classification is implemented, the judgment basis of each category will be clear, so that the applicant can make clear judgment, carry out research work and prepare application materials in accordance with the new requirements, and further encourage the enterprise to establish and develop innovative products Wang Heng: in the past, China was classified according to traditional Chinese medicine and chemical medicine Sometimes the boundary between traditional Chinese medicine and chemical medicine is not clear Now it is very beneficial to separate traditional Chinese medicine, chemical medicine and biological products, whether for registration, production specification or supervision In addition, it is a good thing for pharmaceutical enterprises to stipulate all kinds of declaration materials needed for various drugs, which is more convenient for auditing and standardizing production, and more conducive to future production and operation supervision Dai Wenjie: registration is the pre management for market access Refinement itself is the basic requirement of the standard process classification management It is certain that the more detailed it is, the higher the refinement efficiency and the lower the efficiency and cost As for the impact on drug registration once implemented, for domestic innovative drugs and imported innovative drugs, the requirements and processes of registration data can basically be carried out simultaneously, with higher efficiency Xu Yuanhu: the reason why the drug registration categories are detailed is that the registration categories can be updated in time according to the product characteristics, innovation level and evaluation management needs of the registered drugs, rather than entangled in several registration categories, so as to reduce the loopholes caused by registration categories in market access, bidding and other fields Once drug classification is implemented, it will be more convenient to distinguish and manage drug registration Medical Observer: a chapter of "accelerating the registration of drugs on the market" is added to the administrative measures for drug registration (Revised Draft for comments), which clarifies the four acceleration channels of rolling review guidance, conditional approval, priority review and approval, and special approval, as well as the requirements of the scope, procedures, support policies and so on What is the positive significance of setting up four acceleration channels? Can the current situation of "congestion" be alleviated? Liu Mingrui: the gratifying change of this draft of measures for the administration of drug registration is that it actively supports the registration of innovative drugs and clearly defines four types of priority review sequences: breakthrough treatment drug procedure, conditional approval procedure, priority review and approval procedure and special review and approval procedure On the one hand, these priorities are to keep in line with the international drug registration system; on the other hand, they are to enable innovative drugs with real clinical value to be registered and listed as soon as possible through the rapid approval channel, which can greatly alleviate the "congestion" of approval Huang Bing: This is conducive to promoting the development of China's pharmaceutical industry, timely meeting the needs of the public for drug use, accelerating the implementation of new laws such as the law of traditional Chinese medicine, the law of vaccine management and the law of drug management, which can alleviate the effects of these specific directions to a certain extent, accelerate the registration specifications and the guidance of new drug research and development, and also accelerate the progress of drug approval , which is conducive to accelerating the registration of drugs on the market Xu Yuanhu: it's a great advantage for innovative enterprises, and it's a kind of exercise for enterprise's R & D ability, project mastering ability and RA personnel's ability It can further alleviate the current situation of "congestion", but it is also necessary to prevent "accelerating the registration on the market" from becoming a "regular option" for new drug registration, otherwise it will cause new "congestion" Yang Hua: setting up four acceleration channels to encourage drug innovation oriented by clinical value, and giving priority to drug evaluation that needs to be accelerated according to law will promote the project development of related drugs such as children's drug use, rare disease drug use and clinical shortage drug use, and accelerate the process of listing these drugs However, this policy is highly targeted and may have limited effect on easing the "congestion" of approval There are still problems in the "two in one" examination Pharmaceutical Observer: the measures for the supervision and administration of pharmaceutical production (Revised Draft for comments) covers inspection responsibilities, inspector system, cross provincial inspection responsibilities, inspection contents and forms, etc in the future, GMP certification will be changed to supervision So, how to do a good job in supervision and management, in order to reduce the burden of enterprises, at the same time, effectively crack down on bad enterprises, to ensure the safety of drug use? Liu Mingrui: as for how to ensure the quality and safety of drugs after the GMP certification is cancelled, the state started to deploy relevant measures as early as five years ago First, on December 25, 2015, the drug regulatory information system was delivered online, and seven subsystems, including drug dosage supervision (pilot), GLP supervision (pilot), GCP supervision (pilot), GMP supervision (pilot), drug regulatory analysis, data synchronization, drug safety assessment, were built based on the monitoring and analysis platform, covering drug research and development, production, circulation and other aspects, to ensure drug research Safety of development, production and circulation Second, in the aspect of GMP certification, we choose the drug manufacturing enterprises with good informatization foundation in Zhejiang Province and Jilin Province to conduct irregular off-site supervision of drug production without GMP certification Third, establish a team of full-time inspectors and increase the intensity of flight inspection Therefore, even if the GMP certification is changed to supervision in the future, pharmaceutical enterprises still dare not take it lightly in the face of strong supervision, so as to ensure the drug safety to a large extent Dai Wenjie: personally, I feel that the measures for the supervision and administration of drug production (Revised Draft for comments) are constantly rationalized On the one hand, it is conducive to the supervision and supervision of state institutions, improving the quality of drugs, and on the other hand, it strengthens the main responsibility of drug manufacturers As a supervisory organ, the state organs should first strengthen the strength of flight inspection In terms of frequency, different types of products have different requirements They should use multiple inspection methods to carry out cross inspection without any dead space But the frequency of inspection is too intensive and it is easy to cause time waste in production Therefore, it's better to monitor in the form of data, with system, process and whole chain, including the use process of APIs, excipients, drugs after they are listed, and the data of adverse reactions in the sales process of enterprises, so as to ensure the drug safety of patients to a greater extent Xu Yuanhu: relevant departments should vigorously build food and drug regulatory infrastructure, pay attention to improving the administrative law enforcement; strengthen the construction of regulatory team, improve the system construction, ensure that the regulatory work is truly implemented, and be the umbrella of people's life safety Pharmaceutical Observer: Measures for the supervision and administration of pharmaceutical production (Revised Draft for comments) stipulates that through the combination of registration inspection and GMP inspection, the joint work of different technical institutions at the central and local levels shall be coordinated, so as to solve the problem of multiple licenses in one pre listing inspection and further improve the speed of product listing Can this solve the problems of mutual dependence and unreasonable procedures in registration and regulatory licensing over the years? What are the challenges? Liu Mingrui: according to the regulations issued by the CFDA in 2015, "the on-site inspection of drug registration and production can be combined with the GMP inspection" During the registration process of new drugs and drugs declared according to the new drug procedures, enterprises can apply for the GMP certification at the same time when applying for the on-site inspection of registered production If the general administration is responsible for organizing and implementing the GMP certification, the drug inspection center of the General Administration shall carry out the combined inspection If the provincial administration is responsible for organizing and implementing the GMP certification, the drug certification administration center of the General Administration shall organize the provincial administration to jointly carry out the combined inspection This coordinated the joint work of different technical institutions at the central and local levels, helped to find and solve the unreasonable problems in various registration and supervision procedures, further improved the registration and approval procedures for drug listing, and improved the speed of product listing Previously, the state only provided "two in one" inspection for new drugs or drugs declared according to new drug procedures Since 2015, the industry has generally reflected the following problems: 1 The application for "two in one" inspection is difficult to be approved, and the more approved applications are sterile and biological preparations, as well as drugs with significant clinical value; 2 The time for "two in one" inspection GMP certification is relatively long; 3 Different audits The requirements of the approvers are different The combination registration inspection and GMP inspection will undoubtedly help to improve the speed of product listing If we can sort out the relevant work process and standardize the relevant approval standards according to the existing problems in the past, we will certainly improve the efficiency of enterprise registration Huang Bing: optimizing the examination and approval inspection process and improving the efficiency are undoubtedly the major highlights of this reform For example, different inspection and inspection modes are implemented according to the drug application varieties, innovation degree and risks, and the requirements for the connection between the start and end of the pre inspection of drug registration and inspection are clarified, the laws of drug research and development are respected, and the requirements and procedures for the change during the clinical trial are improved Clear line, etc But there are still some small problems in this process, such as the connection between the central and local work, the clear responsibilities of each department, the connection between the acceptance, examination and inspection, which also involves some specific work Pharmaceutical Observer: for the certification of GSP, which is concerned by the industry, the measures for the supervision and administration of pharmaceutical trade (Draft for comments) cancelled the preparation approval and GSP certification of pharmaceutical trading enterprises In the past, the examination and approval of retail drugstores focused on the GSP specification Now, will the "integration of two certificates" promote the development of retail drugstores? How to ensure that the supervision of retail pharmacies is not relaxed? Dai Wenjie: the current situation of retail pharmacies in China is very polarized On the one hand, there are relatively regular large chain pharmacies