The State Council's abolition of the registration of domestic drugs for preliminary examination ushered in new changes in the pharmaceutical industry
The era of comprehensive upgrading of domestic drugs has come. On March 6, the State Council promulgated the Decision on the Cancellation and Delivery of a Batch of Administrative Licensing Matters, No. 6 of Guofa , which cancelled 25 administrative licensing matters and delegated six administrative licensing levels. Specifically, the abolished 25 administrative licenses include: the preliminary examination of domestic drug registration, the qualification confirmation of prosthetic limb and orthosis (auxiliary equipment) production and assembly enterprises, and the examination and approval of clinical trials of new veterinary drugs.
Among them, abolishing the preliminary examination of the registration of domestic drugs means that in the future, the application for registration of domestic drugs will be accepted directly by the State Administration of Pharmaceutical Supervision instead of the preliminary examination of provincial departments. This is undoubtedly another important measure to optimize the process of drug registration, examination and approval in China.
According to the pre-revision drug registration management measures, the application for approval of drug registration needs to go through the preliminary examination of provincial drug supervision and administration departments, including the examination of the completeness of the original materials of drugs, and the field investigation of the trial-production conditions, etc. At the same time, the provincial, autonomous regions and municipalities directly under the Central Government should also complete the examination of the declaration data and the examination of samples in accordance with the technical requirements for drug approval. Examination items include reviewing pharmacological (including pharmacological and toxicological) research data and testing samples, and excluding research on new detection methods for reporting units.
After the abolition of the preliminary examination, when registering and declaring domestic drugs, there is no need to go to the preliminary examination link of provincial drug regulatory departments, the standards are further unified, and the process is greatly simplified. This is another good thing after the change from approval system to acquiescence system and priority review to immediate review. More new drugs and good drugs will be put on the market at an accelerated pace.
Previously, the Chinese government has repeatedly requested and issued policies to speed up drug registration and approval to meet the urgent needs of patients. On March 6, Premier Li Keqiang of the State Council came to the delegation of Guangxi to participate in the deliberation of the report on the work of the government. He also said that we should deepen the reform of "release uniforms" and strengthen the construction of weak links in the fields of education, medical treatment and old-age care. The abolition of the initial drug registration examination will undoubtedly improve the efficiency of drug examination and approval in China, and accelerate the time for new drugs and generic drugs to go on the market.
According to the requirements, the State Pharmaceutical Regulatory Bureau should optimize its services and strengthen its supervision through the following measures: 1. Optimizing the working process, improving the working standards and doing a good job of direct acceptance. 2. Improving the professional competence of drug registration and review personnel, using the most rigorous standards, the strictest supervision, the strictest punishment and the most serious accountability, strictly implementing the technical review and approval, tightening the registration and listing of drugs, and earnestly strengthening drug safety supervision.
The State Council requires that all regions and departments concerned should do a good job in carrying out and linking up the administrative licensing matters for cancellation and decentralization, formulate post supervision measures for good health, and adopt "double random, one open" supervision, key supervision, credit supervision, and "Internet + supervision" to ensure that they are open, accessible and managed. Good. Within 20 working days from the date of promulgation of this decision, the relevant departments shall publish the rules of supervision after the event to the public in accordance with the regulations, and strengthen publicity, interpretation and supervision of implementation.
According to the relevant administrative measures, "Drug Registration Application" covers the application for clinical trials, licensing for drug listing, supplementary application after listing and re-registration.
Industry analysis shows that those drugs that fail to pass the consistency evaluation on time, fail to pass the quality and efficacy, and have not been manufactured for a long time will be blocked outside the new threshold of drug registration and accelerate the elimination. With the new policies of purchasing with quantity and reform of medical insurance payment system being carried out, domestic drugs will soon enter the stage of comprehensive upgrading.
Domestic Pharmaceutical Examination, Simplified Registration Procedure and Stricter Supervision
It can be seen that while the State Council explicitly abolished the preliminary examination of the registration of domestic drugs, it also requires the State Drug Administration to optimize its services and strengthen its supervision. Optimize work flow, improve work standards, and do a good job of direct acceptance.
We should improve the professional competence of drug registration and review personnel, strictly implement technical review and review with the most stringent standards, stringent supervision, stringent punishment and serious problems, firmly control the entry point of drug registration and listing, and earnestly strengthen drug safety supervision.
This means that, in the future, the work of drug examination and approval will be speeded up, while the requirements for drugs will be higher.
In fact, in recent years, under the background of the reform of the drug approval system, the personnel ratio and specialization construction of the national drug approval system have been continuously strengthened.
On February 19, at the regular briefing of the State Council on policy, Wang Ping, Director-General of the Drug Registration Department of the State Drug Administration, introduced the work of approval of new drugs in 2018. At present, the time for approval of new anticancer drugs in China has been reduced by half, averaging about 12 months, which is in line with the speed of approval in developed countries.
Behind it are six major policy initiatives launched by the State Pharmaceutical Regulatory Bureau to speed up the approval of new drugs. It is important to recruit high-level talents for the society, strengthen the power of drug review and greatly improve the efficiency of drug review by means of government purchasing services.
Analysts believe that with the tightening of drug registration management, a large number of drugs that can not meet the new requirements, such as generic drugs that fail to complete the conformity evaluation on time, will be excluded from "re-registration".
Combination boxing has come out, and the pharmaceutical industry in China will be upgraded in an all-round way.
It should also be noted that the reform of drug registration is only a microcosm of the reform of drug supervision and management mode.
On Monday (March 4), at the first press conference of the Second Session of the 13th National People's Congress, Zhang Yesui, spokesman of the Congress, responded to questions from reporters and said that he would speed up legislation in the field of guaranteeing and improving people's livelihood and promoting the construction of ecological civilization.
The Pharmaceutical Administration Law (Amendment) and Vaccine Administration Law, which have long been concerned by the industry, are among them. According to Zhang Yesui, the relevant legislative plan has been preliminarily drawn up and will be revised and perfected in accordance with the opinions put forward by the delegates at this Congress and published in time.
These two legislations, especially the Drug Administration Act (Amendment), will have a crucial and even subversive impact on the pharmaceutical industry.
According to the Drug Administration Law (Draft Amendment) promulgated by China National People's Congress in November 2018, strengthening the whole process supervision, implementing the system of license holders for listing, reforming and improving the system of drug examination and approval, encouraging drug innovation, and strengthening post-event supervision are all the key points of drug supervision in the next step.
This also indicates that our drug supervision and management mode will change from the previous "heavy product approval, light process supervision" to the full chain, full cycle and whole process supervision mode.
It can be seen that in this transformation, as the source, the adjustment of drug registration management methods is very important.
Take the system of listed license holders as an example. In the past, drug registration and production licensing were bound, which not only did not encourage innovation, but also resulted in low-level duplicate construction to a certain extent.
The revised "Drug Administration Measures" will introduce the system of market license holders, so that researchers without production conditions can also obtain new drug registration licenses, which will greatly stimulate the enthusiasm of relevant personnel in the research and development of new drugs. In this process, the drug registration management methods also need to be adjusted.
In fact, as early as October 24, 2017, the former State Administration of Food and Drug Administration issued the "Drug Registration Management Measures (Revised Draft)" (Draft for Opinions). It has been mentioned that "the State Drug Regulatory Department is responsible for the management of the national drug registration work".
Analysts pointed out that starting with the abolition of the preliminary examination of drug registration by the State Council, the "combination boxing" of drug regulatory model reform has been launched. In the future, the supervision of drug production, circulation and use will continue to be strengthened. As an important part of the "three-medicine linkage", the result will also point to the superiority of the whole industry. The survival of the fittest and the overall upgrading.