In the Proposal, the Central Committee of the Democratic League recommended that:
1. Establish a scientific and rigorous supervision system for the wholesale and distribution of biological products, increase the number of qualified wholesale and inspection institutions, and clarify the sampling duties of food and drug regulatory departments at provincial, municipal and district levels. On the basis of the existing wholesale and testing institutions for biological products, we should gradually increase the number of wholesale and testing institutions for biological products, and strive to have at least one laboratory in each province in the country comparable to the capacity and scale of the Chinese Food and Drug Verification Research Institute by 2025. The State Pharmaceutical Regulatory Department must sample all the safety and effectiveness indicators of each batch of vaccine produced by enterprises and check them at different levels. To clarify the responsibilities and legal responsibilities of the food and drug regulatory departments at the national, provincial, municipal and district levels in the supervision of the wholesale of biological products in the form of law, so as to ensure the safety and effectiveness of the vaccines actually received by grass-roots medical institutions.
2. Improving the publicity and electronic supervision and inquiry system for the wholesale of biological products, ensuring that the public can accurately and timely inquire about the situation of the wholesale of biological products such as vaccines, and actively creating an atmosphere for the whole society to jointly supervise the wholesale of biological products. To amend the relevant provisions of the Regulations on the Management of Wholesale and Distribution of Biological Products concerning information disclosure, to increase the content of public announcement to the public and recipient units, and to clarify the legal liability for not publicizing in time. Adding biologicals column on the official website, publicizing regularly the qualified status, safety and validity of each batch of vaccines and other indicators, sampling units, responsible persons and other information; and adding a platform for querying the qualified status of vaccines wholesale on the homepage, so that the public can inquire about the situation of vaccines wholesale by inputting the vaccines batch number or scanning the bar code information. On the basis of the existing Ali health mobile phone APP vaccine query function, we will increase the qualified query for the wholesale of biological products, which is consistent with the publicity on the official website, so as to facilitate the public to timely inquire about the vaccine inspection situation and fulfill the social supervision obligations.
3. To amend and improve the existing laws and regulations so as to deal with the crime of endangering public safety with strictness, involving illegal production, sale and poor supervision of biological products. The behavior of producing, selling and letting unqualified vaccines and other biological products flow into the market is regarded as a serious public safety hazard. According to the provisions of the Criminal Law, the responsible persons of enterprises, relevant responsible persons and inspection institutions shall be strictly investigated for criminal responsibility according to the crime of endangering public safety, and the units responsible for supervision shall be strictly investigated for their omission and joint legal responsibility so as to allow violations of the law. They are subject to due legal sanctions.
Source: Peng Mei News Responsible Editor: Qian Juanxiao_NBJ10675