Newly revised Drug Administration Law, implementing the "four strictest" to effectively ensure the safety of public drug use

On August 26, 2019, the 12th meeting of the Standing Committee of the 13th National People's Congress closed in Beijing, and the meeting voted to adopt the amendment to the drug administration law of the people's Republic of China The newly revised Drug Administration Law will come into force on December 1, 2019 This is the second systematic and structural major revision of the drug administration law since it was promulgated in 1984 It has raised the achievements of reform and effective practices in the field of drugs into laws, providing a stronger legal guarantee for public health It is the basic law of China's drug supervision to summarize the reform results and revise the drug administration law comprehensively and systematically The current drug administration law was formulated in 1984, revised comprehensively for the first time in 2001, and revised some articles twice in 2013 and 2015 The promulgation and implementation of drug administration law has played an important role in standardizing drug production and marketing activities, strengthening drug supervision and management, ensuring public drug safety, and promoting the development of drug industry However, with the development of social economy and drug industry, the current drug administration law, the new requirements of the CPC Central Committee and the State Council for drug safety, the new expectations of the people for drug safety, and the new situation faced by drug regulatory work and industrial development all have certain gaps There are few measures to encourage innovation, insufficient penalties for illegal acts, and scientific regulatory means Relative lag In order to adapt to the current new requirements, expectations and situations, further improve the drug safety management system and enhance the ability of drug safety management, the 12th and 13th NPC Standing Committees incorporated the revision of drug management law into the five-year legislative plan and accelerated the revision work In October 2018, the drug administration law (Revised Draft) was submitted to the sixth meeting of the Standing Committee of the 13th National People's Congress for initial deliberation, and after the meeting, public opinions were solicited During the deliberation, some suggestions were made that the current drug administration law has not been greatly revised since it was revised in 2001 It is suggested that the achievements of reform and effective practices in the field of drugs over the years be upgraded to law and the revised draft be changed to the revised draft In April 2019, the tenth meeting of the Standing Committee of the Thirteenth National People's congress reviewed the drug administration law (Revised Draft) On August 26, 2019, the 12th meeting of the Standing Committee of the 13th National People's Congress held its third deliberation and voted for approval The newly revised Drug Administration Law comprehensively implements the "four strictest" requirements of the CPC Central Committee on drug safety, clarifies the mission of drug administration to protect and promote public health, establishes the basic principles of people's health as the center, adheres to risk management, whole process control and social co governance, and requires the establishment of a scientific and strict supervision and management system to comprehensively improve drug quality, To ensure the safety, effectiveness and accessibility of drugs These fully reflect the revision of the drug administration law, adhere to people-oriented, problem oriented, respect for the law, adhere to the international vision, adhere to reform and innovation, adhere to the distinctive position of scientific development, fundamental compliance and basic requirements Encourage R & D and innovation to ensure supply accessibility In August 2015, the State Council issued opinions on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No 44) In October 2017, the central office and the State Office issued opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices (Ting Zi [2017] No 42) Focusing on the five themes of "innovation, quality, efficiency, system and ability", they put forward suggestions A series of historic and innovative reform measures, such as encouraging drug R & D innovation, carrying out the pilot of drug listing license holder system, reforming clinical trial management, accelerating the review and approval of drug listing, etc In recent years, the reform and innovation of drug regulation have been vigorously promoted, and remarkable results have been achieved The newly revised Drug Administration Law will consolidate effective reform measures into legal achievements, encourage the development and innovation of new drugs, and lay a more solid legal foundation for further promoting drug reform Support drug innovation oriented by clinical value with definite or special curative effect on human diseases Encourage the development of new drugs with new treatment mechanism, treatment of serious life-threatening diseases or rare diseases, multi-target and systematic regulation and intervention function for human body, and encourage the development and innovation of drugs for children Establish and improve the drug review and approval system Through a series of measures to improve the efficiency of review and approval, optimize the review and approval process Such as the establishment of communication, expert consultation and other systems, the clinical trial from the approval system to the expiration of the implied license system, the bioequivalence test and drug clinical trial institutions for the record management At the same time, priority shall be given to the examination and approval of new drugs and children's drugs urgently needed in clinic, for the prevention and treatment of major infectious diseases and rare diseases, etc.; for the treatment of diseases that are seriously life-threatening and have no effective means of treatment, and for the urgently needed drugs in public health, conditions may be attached to the approval for listing All sectors of the society pay close attention to the shortage of commonly used drugs and emergency (rescue) drugs in China The newly revised Drug Management Law makes special provisions on "drug reserve and supply", which makes clear that the State implements the drug reserve system, the state establishes the monitoring system of drug supply and demand, the State implements the management system of drug shortage list, and the State implements the priority evaluation system of drug shortage Many departments strengthen the joint efforts Drug supply guarantee Adhere to the whole process control and implement the responsibilities of all parties Drug safety is related to public life and health On the basis of summarizing the experience of drug management in the international community, the newly revised drug management law further clarifies that drug safety work should follow the basic principles of "risk management, whole process control and social co governance", and further clarifies the responsibility of quality and safety in the whole life cycle of drugs based on the implementation of drug listing permit holder system Ren, firmly hold the bottom line of public security The holder of the drug listing license shall be responsible for the safety, effectiveness and quality reliability of the drug in the whole process of drug development, production, marketing and use according to law The third chapter "drug marketing license holder" in the newly revised "Drug Administration Law" has made a comprehensive and systematic regulation on the conditions, rights, obligations and responsibilities of the holder The drug administration law was revised to strengthen the information requirements of the whole process of drugs When engaging in drug development, production, marketing and use activities, laws, regulations, rules, standards and specifications shall be followed to ensure the authenticity, accuracy, integrity and traceability of the whole process information The newly revised Drug Administration Law also strictly controls the links of drug development, production and circulation It is stipulated that when engaging in drug development, the quality management standards for non clinical drug research and clinical drug trials shall be followed to ensure that the whole process of drug development continues to meet the legal requirements It is stipulated that the holder shall establish a drug quality assurance system and strictly release the drugs on the market The holder shall, in accordance with the provisions of the state, comprehensively evaluate and verify the impact of the changes on the safety, effectiveness and quality controllability of the drugs At the same time, the holder is required to establish and implement a traceability system to ensure the traceability of drugs The newly revised Drug Administration Law also puts forward clear requirements for post marketing management of drugs It is required to establish an annual report system, and the holder shall report the production and sales, post marketing research, risk management, etc of drugs to the drug regulatory authorities in accordance with the regulations At the same time, the holder shall take the initiative to carry out post marketing research, further verify the safety, effectiveness and quality controllability of drugs, and take risk control measures for drugs with identified risks in time If damage is caused to the user, he shall be liable for compensation according to law In addition, the newly revised Drug Administration Law also strengthened the implementation of the concept of drug life cycle management from the aspects of drug vigilance, supervision and inspection, credit management, emergency response, refined and improved the treatment measures of drug regulatory authorities, and improved the regulatory efficiency The revision also strengthened the concept of "social co governance" of drug safety, strengthened the responsibilities of local governments, relevant departments, drug industry associations, news media and other aspects, and worked together to ensure drug safety Severely punish and punish those who violate the law and implement the punishment until the people's Republic of China newly revised the drug administration law, and comprehensively increase the punishment for illegal acts According to special provisions, those who violate the provisions of this Law and constitute a crime shall be investigated for criminal responsibility in accordance with the law, and the high-pressure situation of drug safety crimes shall be clearly maintained Increased the range of property penalties For example, for illegal activities such as production and operation without license, production and sale of fake drugs, the amount of fine will be increased from twice to five times of the value of the goods to 15 to 30 times If the value of the goods is less than 100000 yuan, the minimum fine will be 1.5 million yuan The fine for the illegal act of producing and selling inferior drugs has also increased from one to three times the value of the goods to ten to twenty times the value of the goods The strength of qualification punishment has been increased The qualification penalty for the person responsible for the illegal act of fake and inferior drugs has been raised from ten-year prohibition to life-long prohibition The enterprises whose production and sales of fake drugs have their licenses revoked will not accept their corresponding applications within ten years Increased means of free punishment The public security organ may detain the relevant persons in charge for five to 15 days if the circumstances of the production and sale of fake drugs and the production and sale of substandard drugs are serious, or if the circumstances of the forgery and fabrication of the license and the fraud of the license are abominable For enterprises with serious violations of the law, the newly revised Drug Administration Law implements "punishment to person" While punishing enterprises in accordance with the law, the legal representative, main person in charge, directly responsible executives and other responsible personnel of enterprises are also punished, including confiscating their incomes, fines, a certain period of time or even life-long prohibition during the period of violation The newly revised Drug Administration Law also improved the civil liability system This includes making clear the liability of compensation for drug listing license holders and drug manufacturing and trading enterprises; stipulating that the agents of overseas drug listing license holders in China shall bear joint and several liability with the holders; implementing the first responsibility system of civil compensation; the victims may demand punitive compensation for producing fake and inferior drugs or knowing that the fake and inferior drugs are still sold and used When greatly improving the punishment of illegal acts, the newly revised drug administration law strictly implements the principle of "excessive punishment is equal", distinguishes general illegal acts from those with serious circumstances and serious consequences, and focuses on increasing the punishment of subjective intent or serious illegal acts.