The revised draft of the drug administration law has entered the second trial, and the punishment for drug violations has been strengthened!

On April 20, the 10th meeting of the Standing Committee of the 13th National People's Congress was held in Beijing The draft drug administration law is to be further amended to clarify that the third-party network platform shall not directly sell prescription drugs ▍ the third-party network platform, the third-party platform provider who is not allowed to sell prescription drugs online, shall put on record, perform the obligations of qualification review, stop and report illegal acts, stop providing online sales platform services, and make it clear that the third-party platform is not allowed to sell prescription drugs directly through the drug network ▍ strengthen drug price supervision and carry out cost investigation Some members of the Standing Committee, local authorities and the public suggest strengthening drug price supervision to ensure drug supply Accordingly, the Constitution and Law Committee of the National People's Congress proposed to add the following contents: first, the state monitors drug prices, conducts cost price investigation when necessary, strengthens drug price supervision and inspection, investigates and deals with drug price violations according to law, and maintains drug price order Second, the State implements a system of early warning and list management of drugs in short supply Third, the State encourages the development and production of drugs in short supply, and gives priority to the review and approval of drugs in short supply and APIs that are urgently needed in clinical practice Fourth, the relevant departments of the State Council may take appropriate measures such as production, price intervention and import organization to ensure the supply of drugs Fifth, the holder of the drug listing license and the drug production and marketing enterprise shall fulfill their social responsibilities to ensure the production and supply of drugs ▍ some members of the Standing Committee, departments and the public who are allowed to transfer the drug registration certificate should clarify the requirements of the drug registration application, make provisions for the conditional approval of drugs urgently needed in the clinical treatment of serious diseases, allow the transfer of the drug registration certificate, strengthen the change management in the process of drug production, and standardize the online sales of drugs Accordingly, the Constitution and Law Committee of the National People's Congress proposed to add the following provisions: first, the applicant should provide authentic, sufficient and reliable research data, materials and samples to prove the safety, effectiveness and quality controllability of drugs Second, the urgently needed drugs that meet the requirements can be subject to conditional approval Third, after approval, the holder of the drug listing license can transfer the drug registration certificate and clarify the conditions and obligations of the transferee Fourth, implement classified management for changes in the pharmaceutical production process Major changes shall be examined and approved Other changes shall be filed or reported, and the impact of changes shall be comprehensively evaluated and verified ▍ in addition, some members of the Standing Committee, local governments and the public also proposed that the punishment of drug violations should be further strengthened, the cost of violations should be increased, and severe punishment should be given Accordingly, the Constitution and Law Committee of the National People's Congress proposed the following modifications: first, increase the types of punishments receivable For those who fail to carry out the monitoring or reporting of adverse drug reactions in accordance with the provisions, the representative organizations of drug listing license holders established by overseas enterprises in China or the designated enterprise legal persons fail to perform the relevant obligations in accordance with the law, the third-party platform for drug online sales fails to perform the obligations such as qualification examination, reporting illegal acts, stopping the provision of online sales platform services, and fabricating and distributing fake drugs For four kinds of illegal acts of product safety information, the corresponding legal liability shall be increased Second, we will increase penalties We will increase the number of fines and increase the amount of fines for illegal activities such as producing and selling drugs without a license, producing and selling fake drugs and substandard drugs We will increase the provisions on the investigation of criminal responsibility according to law for the legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the unit engaged in the production and sale of fake drugs and substandard drugs, and increase the provisions on administrative detention for those who are not considered as crimes or do not constitute crimes according to law 3 Increase punitive damages If the production of fake or substandard drugs or the sale of fake or substandard drugs is still known, resulting in death or serious health damage, the victim may claim corresponding punitive damages ▍ some members of the Standing Committee, departments, local governments and the public have proposed to clarify the responsibilities of drug listing licensors The revised draft is not comprehensive and clear enough about the responsibilities of drug listing licensees, so the responsibilities of drug listing licensees in all aspects should be further clarified After study, the Constitution and Law Committee proposed to make special provisions for the drug listing license holders, adding the following provisions: first, the drug listing license holders shall be responsible for non clinical research, clinical trials, production and operation, post marketing research, adverse reaction monitoring, reporting and treatment of drugs Second, the holders of drug marketing licenses shall establish a drug quality assurance system, with quality directors independently responsible for drug quality management Third, the holder of the drug listing license shall sign an agreement with the enterprises entrusted with the production, operation, storage and transportation of drugs to ensure that these enterprises continue to have the ability of quality assurance and risk management ▍ some members of the Standing Committee, departments and local governments also proposed that the post marketing management of drugs should be further improved Accordingly, the draft proposal of the Constitution and Law Committee of the National People's Congress stipulates the special chapter of post marketing management of drugs, and adds the following provisions: first, the holders of drug marketing license should take the initiative to carry out post marketing research Second, the holders of drug marketing licenses shall carry out adverse reaction monitoring and take risk control measures in time for the drugs with identified risks Third, the holder of the drug listing license shall take corresponding risk management measures for the drugs subject to conditional approval and complete the relevant research work within the prescribed time limit ▍ clinical trials of drugs should conform to the ethical principles proposed by some members of the Standing Committee, departments and the public, and should be targeted to encourage the development of new drugs; clinical trials are the key link of drug development, and should provide for ethical review, safeguard the legitimate rights and interests of subjects, and appropriately expand the scope of subjects Accordingly, the Constitution and Law Committee of the National People's Congress proposed to add the following contents: first, encourage drug innovation oriented by clinical value, and support the research of new drugs with multi-target and systematic regulatory and intervention functions for human body The second is to carry out clinical trials of drugs in accordance with ethical principles and clarify the establishment and responsibilities of the ethics committee Third, to carry out clinical trials of drugs, we should truthfully explain the risks, obtain the consent of the subjects, and protect the legitimate rights and interests of the subjects Fourth, eligible drugs that are undergoing clinical trials can be used free of charge for other patients with the same condition in clinical trial institutions On the same day, the draft vaccine management law was also submitted to the 10th Session of the Standing Committee of the 13th National People's Congress for further deliberation ▍ up to 30 million members of the Standing Committee, local authorities and the public can be fined for producing and selling fake and inferior vaccines They proposed that more efforts should be made to punish illegal acts and increase the cost of illegal acts The second review draft was revised to increase the amount of fine for illegal activities such as producing and selling fake and inferior vaccines, providing false data for applying for vaccine registration, and violating the relevant drug quality management norms According to the second review of the draft, if the vaccines produced and sold are fake drugs, the fine standard shall be a fine of 15 times to 30 times the value of the illegally produced and sold vaccines; if the value of the vaccines is more than 500000 yuan but less than 1 million yuan, a fine of 5 million yuan to 30 million yuan shall be imposed The second trial draft also improved the provisions of punitive compensation, making it clear that if the vaccine is still sold and vaccinated even though it has quality problems, causing serious damage to the death or health of the recipient, the recipient or his close relatives can also demand corresponding punitive compensation in addition to compensation for the loss ▍ it is required that the vaccination information can be traced back to events such as expired vaccines and dropped packages in the vaccination process in some places, and the second review draft also responds to them, further strengthening the vaccination management, standardizing the vaccination behavior, and making clear that the requirements of "three checks and seven pairs" and the vaccination information can be traced and inquired into the draft law "Three checks and seven pairs" means that before the implementation of vaccination, medical and health personnel shall check the health status and vaccination taboos of the recipients, check the vaccination certificate (card), check the appearance, batch number and validity of the vaccines and syringes, check the names, ages of the recipients and the names, specifications, doses, vaccination positions and routes of vaccination in accordance with the requirements of the vaccination work specifications The vaccination can only be carried out after the recipient, vaccination certificate (card) and vaccination information are consistent and confirmed to be correct To ensure that the vaccination information can be traced and inquired, medical and health personnel are required to complete and accurately record the "identification information, validity period, vaccination time, medical and health personnel implementing the vaccination, recipients" and other information of the vaccination "varieties, marketing license holders and the smallest packaging units" Vaccination records shall be kept for at least five years.