Medical Network April 28th The Drug Administration Law (Revised Draft) was announced yesterday, soliciting opinions from the society. After that, it will be delivered to the third instance. After the third trial, it will be further voted. If the vote is passed, the new drug management law will be officially introduced.
▍ Drug Administration Law (Revised Draft) for comments
On the afternoon of April 26, China National People's Congress issued the “Drug Management Law (Revised Draft) for comments”, and the date of comments was from April 26 to May 25.
The consultation pointed out that the public can directly log in to China National People's Congress to submit their opinions, or send their opinions to the NPC Standing Committee Legal Affairs Committee (No. 1 West Street, Qianmen, Xicheng District, Beijing, 100805. Please indicate the drug management on the envelope) Draft Law Amendment for Comments). Deadline for comments: May 25, 2019.
▍Request for comments
On April 12th, the Constitutional and Legal Committee held a meeting and reviewed it again. The revision of the main issues of the Drug Administration Law (Revised Draft) is now reported as follows:
There are still regulations that need to be revised
1. Some members of the Standing Committee, departments, experts and the public have proposed that the Drug Administration Law has not been revised since 2001. The draft amendment mainly provides for the implementation of the drug listing permit holder system, and other provisions. It should also be further revised and improved according to the development and regulatory needs of the pharmaceutical industry.
Amendment to revision
It is recommended that the results of the reform of the pharmaceutical sector and effective practices be upgraded to the law, the relevant provisions should be improved in accordance with the requirements of the whole process of drug administration and the management of the entire chain, and the outstanding problems should be standardized in time, and the revised draft should be changed to the revised draft.
The content of vaccine management is included in the vaccine management law.
At the same time, it is necessary to deal with the relationship with the vaccine management law that is being developed. After studying the Constitution and Law Committee, it is proposed to adopt a revised method to modify the Drug Administration Law, adjust the structure according to the aspects of drug development and registration, drug production, drug management, pharmaceutical management, post-marketing management, etc., and incorporate some aspects related to vaccine management. Vaccine Management Act.
Comprehensively improve the quality of medicines
2. Some members of the Standing Committee, localities and experts have proposed that the basic requirements for drug management should be reflected in the General Regulations. After studying the Constitution and Law Committee, it is proposed to add provisions: drug management should focus on the health of the people, establish a scientific and strict supervision and management system, comprehensively improve the quality of drugs, and ensure the safety, effectiveness and accessibility of drugs. (Article 3 of the revised draft)
Participation in drug management
Third, some members of the Standing Committee, departments, experts and the public have suggested that drug management needs to participate in all aspects, work together to form a joint force, and propose to increase the content of social co-governance. After studying the Constitutional and Legal Committee, it is proposed to add provisions:
First, governments at all levels and the news media should strengthen the publicity and education of drugs and the popularization of knowledge.
The second is to play the role of the pharmaceutical industry association and strengthen industry self-discipline.
The third is to commend and reward units and individuals that have made significant contributions to the development, production, operation, use and supervision of pharmaceutical products. (Articles 12, 13 and 14 of the revised draft)
Legislation encourages the creation of new drugs
4. Some members of the Standing Committee, departments and the public have suggested that the development of new drugs should be targeted. Clinical trials are a key part of drug development. They should make ethical review, protect the legitimate rights and interests of the subjects, and appropriately expand the scope of the subjects. Provisions. After studying the Constitutional and Legal Committee, it is proposed to add provisions:
One is to support clinical value-oriented drug innovation research.
Second, the implementation of drug clinical trials should be in line with ethical principles and clarify the responsibilities of the ethics committee.
Third, the implementation of drug clinical trials 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 conditions in clinical trials. (Articles 15, 18, 19 and 20 of the revised draft)
The responsibility of the drug listing license holder needs to be clarified
5. Some members of the Standing Committee, departments, localities and the public have proposed that the amendments to the drug listing permit holders are not comprehensive and clear, and the responsibility of the drug listing permit holders in all aspects should be further clarified.
First, holders of drug marketing licenses shall be responsible for non-clinical research, clinical trials, production operations, post-marketing studies, adverse reaction monitoring, reporting and handling of drugs.
Second, the holder of the drug marketing license should establish a drug quality assurance system, and the person in charge of quality is responsible for the independent management of drug quality.
Third, holders of drug marketing licenses should sign agreements with enterprises entrusted with the production, operation, storage and transportation of drugs to ensure that these enterprises continue to have quality assurance and risk management capabilities. (Amendment of Article 26, paragraph 2, Article 27, Article 28, paragraph 2, paragraph 3, Article 30, paragraph 2, Article 31)
Allow drug registration certificate transfer
After studying the Constitutional and Legal Committee, it is proposed to add provisions:
First, the applicant should provide true, sufficient and reliable research data, data and samples to prove the safety, effectiveness and quality controllability of the drug.
The second is to conditionally approve the urgently needed drugs that meet the conditions.
Third, after approval, the holder of the drug marketing license may transfer the drug registration certificate and clarify the conditions and obligations of the transferee.
The fourth is to implement classified management of changes in the pharmaceutical production process. Major changes should be reviewed and approved, other changes should be filed or reported, and the impact of the changes should be fully evaluated and verified.
Do not sell prescription drugs directly through the drug network sales platform
The third-party platform provider of drug network sales shall file the record, perform the qualification review, stop and report the illegal act, stop providing the network sales platform service and other obligations, and clarify that the third-party platform may not be directly sold through the drug network sales. (Amendment of Article 21, paragraph 2, Article 23, Article 36, Article 41, Article 58)
Strengthen the management of drugs after listing
7. Some Standing Committee members, departments and localities have proposed that strengthening post-marketing management is an important part of continuously improving the quality of medicines and ensuring the safety of medicines. It is recommended to further improve relevant content.
After studying the Constitution and Law Committee, it is recommended to make a special chapter on the post-marketing management of drugs, and increase the regulations:
First, holders of drug marketing licenses should take the initiative to conduct post-marketing research.
Second, holders of drug marketing licenses should conduct adverse reaction monitoring and take timely risk control measures for drugs that have identified risks.
Third, holders of drug marketing licenses should take corresponding risk management measures for drugs with conditional approval and complete relevant research work within the prescribed time limit. (Articles 72, 74 and 77 of the revised draft)
Strengthen drug price supervision and carry out cost investigation
8. Some members of the Standing Committee, local and public have suggested that the high price of medicines and the shortage of supply are prominent problems in the pharmaceutical field. It is recommended to take measures to strengthen drug price supervision and guarantee the supply of medicines. After studying the Constitutional and Legal Committee, it is proposed to add provisions:
First, the state monitors drug prices, conducts cost and price surveys when necessary, strengthens drug price supervision and inspection, investigates and punishes drug price violations according to law, and maintains drug price order.
Shortage drugs can be intervened at an appropriate price
Second, the state implements a short-term drug warning and inventory management system.
Third, the state encourages the development and production of shortages of drugs, and gives priority to the review and approval of clinically needed shortages of drugs and APIs.
Fourth, the relevant departments of the State Council can take appropriate measures such as production, price intervention and organization of imports for shortage of drugs to ensure the supply of drugs.
Fifth, holders of drug marketing licenses and pharmaceutical production and operation enterprises shall perform social responsibilities and guarantee the production and supply of drugs. (Revised Article 78, Article 88, Article 89, paragraph 1, Article 90, Article 91, Article 92)
Increase penalties for drug violations
9. Some members of the Standing Committee, local and public organizations have proposed that they should further increase penalties for drug violations, increase illegal costs, and severely punish severe punishments. After studying the Constitutional and Legal Committee, it is proposed to make the following changes:
The first is to increase the types of behaviors that should be punished. For the monitoring or reporting of adverse drug reactions that have not been carried out in accordance with the regulations, the representative office of the drug listing permit holder established by the overseas enterprise in China or the designated enterprise legal person has not fulfilled the relevant obligations according to law, and the third party platform for drug network sales has not fulfilled the qualification review and report. Violation of the law, the cessation of the provision of online sales platform services and other four types of illegal acts of fabricating and disseminating false drug safety information, and increasing the corresponding legal responsibilities (Revised Draft Article 118, Article 121, One hundred and twenty-two, one hundred and thirty-eighth).
The second is to increase penalties. Increase the fines for illegal activities such as unlicensed production and operation of drugs, production and sale of counterfeit drugs, violation of drug production quality management regulations or drug business quality management practices.
Increase punitive damages
Implementing the penalty to the person, increasing the legal responsibility for criminal liability for the legal representative, principal responsible person, directly responsible person in charge and other responsible personnel engaged in the production and sale of counterfeit drugs and inferior medicine units; it is not considered to be a crime or not constituted according to law. For criminal offences, the provisions for administrative detention may be increased (Articles 109, 110, 111, 115, etc.).
The third is to increase punitive damages. Victims may claim appropriate punitive damages if they produce counterfeit drugs, inferior drugs, or know that fake drugs or inferior drugs are still sold, causing death or serious damage to health. (Revised Draft Article 136, paragraph 2)
In addition, some textual changes were made to the draft amendment.
▍ Drug Administration Law Overhaul
On October 22, 2018, the draft amendment to the Drug Administration Law was first submitted to the Standing Committee of the National People's Congress for deliberation.
On April 20, the revised draft of the Drug Administration Law was submitted to the Tenth Session of the Standing Committee of the National People's Congress for consideration. This is the second review of the draft Drug Administration Law.
From the draft amendment to the Drug Administration Law at the first trial to the revised draft of the Drug Administration Law at the second instance, although it is only a word difference, the connotation is very different.
According to the analysis of legal professionals, unlike the amendment, the revision refers to the revision of the legal text by the National People's Congress or its Standing Committee after the revision of a certain law, in lieu of the original legal text. The amendment usually applies to the need to change the important content and chapters of the original law. A major modification of the structure.
Xinhua News Agency pointed out that from the "revision draft" to the "revision draft", it seems to be a legislative technical issue, which actually means that the drug management law will usher in a systematic and structural "overhaul".
▍After the next retrial or delivery vote
Article 7 of the Legislative Law of the People's Republic of China (hereinafter referred to as the "Legislative Law") states that the National People's Congress and the Standing Committee of the National People's Congress exercise the legislative power of the state.
Article 29 clearly states that the legal cases included in the agenda of the Standing Committee meeting shall generally be submitted to the vote after deliberation at three meetings of the Standing Committee.
The specific norm is: the first consideration of the legal case at the meeting of the Standing Committee, the briefing of the proposer at the plenary meeting, and the preliminary review by the breakout session;
The second review of the legal case, in the plenary session, to hear the report of the Law Commission on the revision of the draft law and the main issues, which will be further considered by the break-up meeting;
The third time the case was reviewed, the report of the Law Committee on the results of the review of the draft law was heard at the plenary meeting, and the revised draft of the draft law was reviewed by the breakout session.
In addition, when the Standing Committee considers a legal case, it may convene a joint meeting or a plenary meeting as needed to discuss the main issues in the draft law.
However, Article 30 of the Legislative Law also proposes an exception: that is, a legal case that is included in the agenda of the Standing Committee meeting. If the opinions of all parties are more consistent, they can be submitted to the vote after deliberation at the meeting of the two Standing Committees; For a single or partially modified legal case, if the opinions of all parties are relatively consistent, they may also be put to the vote after deliberation at a meeting of the Standing Committee.
As reviewed by Xinhua News Agency, the revised draft of the Drug Administration Law reviewed at this meeting is a comprehensive revision of the Drug Administration Law. It is adjusted according to drug development and registration, drug production, drug management, pharmaceutical management, and post-marketing management. The structure of the drug administration law and the inclusion of some aspects of vaccine management into the vaccine management law.
Judging from the revision of the two drafts of the second draft, it is obviously not within the scope of the application of Article 30 of the Legislative Law. It is expected that the vote will be submitted after the “three trials”.
The revision of the Drug Administration Law is a comprehensive overhaul that lasted 19 years and has far-reaching implications.
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