Comprehensively improve the level of the rule of law in drug registration and production


Release time:

2020-04-14

The Measures for the Administration of Drug Registration and the Measures for the Supervision and Administration of Drug Production (hereinafter referred to as the two measures) promulgated on March 30 have made a new design and comprehensive standardization of drug registration management and drug production supervision and administration, which are major measures to implement the Drug Administration Law, Vaccine Administration Law and other laws and administrative regulations, in order to comprehensively improve the level of legalization and standardization of drug registration and drug production, it has laid a solid foundation to ensure the safety, effectiveness and controllable quality of drugs.

General Secretary Xi Jinping pointed out: "The situation is developing and the times are advancing. The legal system must continue to develop with the development of the times and practice." The two methods fully draw lessons from the theoretical, practical and institutional achievements of the reform of the drug regulatory system and mechanism, summarize and refine the practical experience and useful practices of drug registration management and drug production supervision and management, closely follow the requirements of the new drug regulatory system, new functions and new missions, closely follow the reality of product innovation and high-quality development in the industry, and strive to build a scientific, strict and efficient drug regulatory system, how to manage "and" what to supervise and how to supervise "drug production have strong pertinence, guidance and operability.

The two methods are to implement the "upgraded version" and "new scale" of the "four strictest". With the development of the times and the progress of science and technology, the "four strictest" standards are constantly improving and developing, rather than being immutable. "If the law changes with the times, it will govern, and if it is governed with the times, it will make meritorious service." The "Measures for the Administration of Drug Registration" adds relevant content such as drug variety files, the supervision of drug research institutions, drug non-clinical research institutions, and drug safety credit files; the "Measures for the Supervision and Administration of Drug Production" has a special chapter on "Legal Responsibility" to comprehensively increase The intensity of administrative penalties for serious violations of drug production quality management standards has increased the amount of fines and cashed penalties to individuals. These new regulatory measures make the implementation of the "four strictest" requirements higher, the standards stricter, the goals more precise, and the strictness more scientific.

 

The two methods are the "converter" of drug regulatory innovation and the "booster" of deepening reform and innovation ". In order to encourage innovation and meet the urgent clinical needs, the "Measures for the Administration of Drug Registration" added a chapter on "Procedures for Accelerating the Registration of Drugs on the Market" to clarify the relevant requirements of the four fast-track channels of breakthrough therapeutic drugs, conditional approval, priority review and approval, and special approval., Clarify the scope, procedures, support policies and other requirements. The measures for the Supervision and Administration of Drug production fully implements the system of drug marketing license holders, optimizes relevant working procedures while clarifying responsibilities, and encourages holders to speed up the listing of products. These measures not only provide a guarantee for the implementation of reform results as soon as possible, but also reserve an "interface" for further deepening reform and innovation ".

The drafting and revision of the two methods adhere to the problem orientation and provide a "new key" to solve practical problems ". In response to the industry's concern about the convergence of various links in the registration management process, the "Drug Registration Management Measures" clarified the time limit and docking path for drug registration acceptance. In order to strengthen the connection between drug registration declaration and production supervision, and to solve the problem of mutual dependence and unreasonable procedures in registration and regulatory licensing matters for many years, the Measures for the Supervision and Administration of Drug Production stipulate that the application for drug production license can be synchronized with the application for marketing license of the drug to be produced on-site inspection, and strive to solve multiple licensing problems in one pre-market inspection, and further speed up the marketing of products.

The two methods further tighten the "responsibility chain" and compact the "responsibility to people". The Measures for the Administration of Drug Registration clearly defines the starting node and docking requirements for review and inspection, so that the responsibilities of each link are clear, the whole chain is seamlessly connected, the registration process is clear and transparent, and the registration time can be expected. The measures for the Supervision and Administration of Drug production further clarify the legal responsibilities of drug marketing license holders and drug production enterprises, refine and clarify the circumstances and penalties for relevant illegal acts, and force drug marketing license holders and drug production enterprises to "assign responsibility to people" and put them in place.

Laws and regulations are written rules and rigid rules. Their vitality lies in their implementation, and their authority lies in their implementation. "There is a system not to implement, more terrible than no system". The key to the implementation of the two methods lies in the practice of the rule of law. The practice of the rule of law is the best way to achieve practical results in the publicity and education of the rule of law. Adhere to the combination of learning and application, universal governance, the implementation of the two methods can achieve the desired results.