Comprehensively strengthen the construction of legal system for drug supervision
The "four beams and eight pillars" of the drug regulatory system have been basically established
Our reporter Wan Jing
Recently, the National Medical Products Administration held a video and telephone conference on national drug regulatory policies and regulations for 2020, fully affirming the achievements of drug regulatory policies and regulations since 2019.
2019 is a crucial year for the construction of drug regulatory policies and regulations. China’s drug regulatory legislation has made new breakthroughs. The Vaccine Management Law and the newly revised Drug Management Law (hereinafter referred to as the “two laws”) have been introduced successively. The “Cosmetic Supervision and Administration Regulations” have been issued. The revision of the "Regulations for the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Two Regulations") has accelerated, and the core supporting regulations such as the "Administrative Measures for Drug Registration" and "Administrative Measures for Drug Production Supervision" and other core supporting regulations have been revised in a timely manner. The "four beams and eight pillars" of the drug regulatory system have been basically established, and breakthroughs have been made in the construction of the regulatory system, which has opened a new journey for the treatment of drugs in accordance with the law in my country.
Implement the traceability system
On August 26, 2019, the twelfth meeting of the Thirteenth National People's Congress Standing Committee voted to approve the amendments to the Drug Administration Law of the People's Republic of China. The most striking aspect of the new version of the Drug Administration Law is the implementation of the drug traceability system, the adherence to full-process management and control, and the establishment and improvement of the drug traceability system. In the direction of "one thing, one code, and the same code," the marketing license holders, production and operation enterprises, and medical institutions should establish and implement a drug traceability system, and each unit should establish its own traceability system to achieve data interconnection. It has also strengthened the implementation of the concept of drug life-cycle management from the aspects of pharmacovigilance, supervision and inspection, credit management, and emergency response.
At the same time, strengthen the responsibility of the main body of the enterprise and fully implement the drug marketing license holder system. The marketing license holder is responsible for the safety, effectiveness, and quality controllability of drugs in the entire process of drug development, production, operation and use according to law. At the same time, it stipulates that the marketing license holder shall establish a quality assurance system and be responsible for all the processes and links of non-clinical research, clinical trials, production and operation, post-marketing research, adverse reaction monitoring, reporting and handling of drugs, and With the ability to compensate.
The most commendable part of the Drug Administration Law is the increase in the punishment for violations. The qualification penalty for the person responsible for the illegal behavior of counterfeit or inferior drugs has been increased from a 10-year ban to a life-long ban. Enterprises whose licenses for production and sale of counterfeit drugs have been revoked will not accept their corresponding applications within ten years.
Xu Jinghe, a member of the Party Leadership Group and deputy director of the State Food and Drug Administration, pointed out that in order to comprehensively strengthen the rule of law in drug supervision, the "four most stringent" regulations must be taken as the fundamental follow-up and action guidelines for supervision. Basic principles, adhere to the supervision mission of protecting and promoting public health, adhere to the supervision theme of innovation, quality, efficiency, system and ability, adhere to the two basic goals of ensuring safety bottom line and pursuing high quality line, and adhere to scientific, rule of law, international The road of development of modernization and modernization, and continuously promote the modernization of the drug regulatory system and drug regulatory capabilities.
Investigate criminal responsibility seriously
Vaccines are related to people's lives and health, and to public health and national security. In order to integrate the entire chain of regulations such as vaccine development, production, circulation, vaccination, abnormal reaction monitoring, safeguard measures, supervision and management, and legal responsibility scattered in multiple laws and regulations, systematically plan and think, raise the legal level, strengthen the law Measures to enhance the pertinence, effectiveness and operability of vaccine legislation. On June 29, 2019, the Eleventh Meeting of the Standing Committee of the 13th National People's Congress voted and passed the Vaccine Administration Law of the People's Republic of China in 2019 It will be officially implemented from December 1, 2014.
It is reported that my country's vaccine management law is currently the world's first comprehensive vaccine management law. It clearly stipulates that the state implements the strictest management system for vaccines. Adhere to safety first, risk management, overall monitoring, scientific supervision, and social governance.
Song Hualin, a professor at the Law School of Nankai University, pointed out that this special law for vaccine management responds to the expectations of the people, solves the outstanding problems in vaccine management, and fully reflects the "four most stringent" requirements in the field of medicine and food in the system design. . As a management law, the "teeth" of the law is very important. From the first deliberation of the Standing Committee of the National People's Congress at the end of December 2018 to the third deliberation recently, the legal liability for illegal and criminal acts of vaccines has been "overweight". The Vaccine Management Law is clear, and criminal responsibility for vaccine crimes is severely investigated according to law.
Recently, Premier Li Keqiang of the State Council signed an order from the State Council, promulgating the "Regulations on the Supervision and Administration of Cosmetics." "Regulations" can be said to have done enough to ensure the quality and safety of cosmetics. For example, implementing corporate responsibility, requiring registrants and filers to conduct safety assessments on cosmetics and new raw materials, strengthening production and operation process management, and strengthening quality and safety control after cosmetics are launched.
At the same time, the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations"), which is known as the "Industry Parent Law", has to be revised, and many measures to impose penalties on individuals are planned to be added, and the penalties for enterprises have also been improved , Industry regulation can be described as unprecedentedly strict.
The main highlight of this revision of the "Regulations" is that it regulates the phenomenon of counterfeit and shoddy medical devices in the current market, and clarifies the concept of counterfeit medical devices, which can solve the following problems: unlicensed medical treatment found in regulatory practice Devices cannot be inspected because there is no relevant standard; some counterfeit products of legitimate companies may be qualified as a result of the inspection, resulting in difficulties in investigation and punishment.
Good laws promote good governance. China’s legal system for drug supervision has been gradually improved, from paying attention to drug quality to paying attention to drug safety, traceability, and full-process supervision, and introducing the concepts of risk management and social co-governance; from ensuring people’s drug safety to protecting and protecting Promote people's health; from establishing drug production and quality management standards to fully implementing the drug marketing license holder system, requiring holders to be able to assess the safety, effectiveness and quality of drugs in the entire process of drug development, production, operation and use Controlling responsibility.
Marked by the "Two Laws and Two Regulations" such as the newly revised Drug Administration Law and Vaccine Administration Law, my country's drug administration legal construction has embarked on a new journey.