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| Vaccine regulation upgrade! The CFDA and the health and family planning commission issued a clear request for regular inspection of enterprises |
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| Author：中國(guó)銘鉉 企劃部 Release Time：2017-9-4 10:44:27 Number Browse：782 |
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On September 1, 2008, the CFDA official website issued a notice on further strengthening the supervision of vaccine circulation and promoting vaccine supply. The notice, issued jointly by the CFDA and national health development planning commission, aims to further implement the newly revised "regulations on the administration of circulation of vaccines and vaccination, standardize the second (hereinafter referred to as the" vaccine ") of the vaccine cold chain store transport management, solve the practical problems in the process of vaccine delivery, ensure the supply of the vaccine. The requirements are as follows:
First, standardize the management of vaccine storage and transportation and improve the efficiency of vaccine delivery
(a) the vaccine production enterprise, vaccine distribution enterprises, vaccines, regional warehouse storage and transport vaccine should strictly carry out "the drugs management quality management standard" the vaccine storage and transportation management regulations; All levels of disease prevention and control agencies, the storage of inoculations and the transport of vaccines should strictly comply with the requirements of the regulations on the management of vaccine storage and transport and the code for vaccination.
(2) vaccine manufacturers may distribute vaccines directly to the county-level disease prevention and control agencies, or they may entrust enterprises with the conditions of cold chain transportation of drugs. The distribution of vaccine can be carried out in the main line transport + regional warehouse + regional distribution. Trunk transport refers to the transport of vaccines from vaccine manufacturers to regional warehousing or direct transport to the county-level CDC; Regional warehousing refers to the cold chain storage activities that occur during the distribution of vaccines from vaccine manufacturers to the county-level disease prevention and control agencies; Regional distribution refers to the process of direct distribution of vaccines from regional warehouses to the county-level CDC.
(iii) vaccine manufacturers should assess the distribution capacity of vaccine distribution enterprises and strictly control the number of distribution enterprises. In the same province, autonomous region and municipality directly under the central government, the same vaccine manufacturers shall not have more than two vaccine distribution enterprises. The enterprise accepting the entrusted delivery shall not entrust it again.
(iv) regional warehousing of vaccines can be used for cold storage of other vaccine manufacturers, cold storage of distribution enterprises and cold storage of regional warehouse enterprises. In order to ensure the timely supply of vaccines, the vaccine can be distributed to the regional storage freezer before the product release.
(5) the vaccine production enterprise shall, in strict accordance with the "the drugs management quality management standard" request for distribution, regional warehousing enterprises of the vaccine cold chain's ability to store, transport conditions and carry out on-site audit, and distribution, regional warehousing enterprises signed contracts on transportation, storage and quality agreement, responsibilities and obligations, clear vaccine quality management requirements.
(6) the vaccine production enterprise shall sign an distribution and storage in the contract within 15 working days from the date the vaccine distribution, regional warehousing, and so on and so forth to the vaccine production enterprise, regional warehousing, to receive the vaccine of institution of disease prevention and control is located at the county level the provincial food and drug supervision department report, enterprise material is responsible for the authenticity, legitimacy of the report. The report is as follows:
1. The vaccine production enterprise production license, business license, certificate of drug approval documents, drug GMP certificate (imported vaccines agency shall provide the corresponding certificate by overseas pharmaceutical manufacturers file).
2. The business license of the vaccine distribution company and the regional warehousing enterprise, and the supervision and inspection by the supervision department of the food and drug administration;
3. The contract for the storage and storage of vaccines and the quality agreement;
4. Audit reports of vaccine manufacturers on entrusted distribution enterprises and regional warehousing enterprises.
Provincial food and drug regulatory departments shall 10 working days after receiving the report material internal government website open vaccine production enterprise, the vaccine varieties, vaccine distribution enterprises, regional warehousing, distribution and regional warehousing contract validity and related information. The vaccine production enterprise should also disclose the above information on the enterprise website at the same time.
(7) the vaccine shall not be mixed with the non-drug; In the case of mixed transport with other drugs, it shall be placed in the transport vehicle to prevent confusion and cross-contamination and ensure that the quality of the vaccine shall not be affected by the mixed transport of the vehicle. Vaccine production enterprises, distribution of using air transport vaccine and transportation must conform to the vaccine required refrigeration temperature control measures, the entire record transportation temperature data, and the distribution to finish air transportation at the county level of institution of disease prevention and control of temperature data upload.
Second, actively promote the whole process of vaccine traceability system construction
The vaccine production enterprise, regional warehousing, distribution enterprise, institution of disease prevention and control, the unit shall establish a vaccine production, storage, transportation, use the whole process of the vaccine tracing system, gradually realize the smallest unit of packaging in a vaccine production, storage, transport, use the whole process of the traceability.
(a) vaccine production enterprises, distribution, regional warehousing enterprises, the institution of disease prevention and control, in the process of transition of vaccine, vaccination units both vaccines that should be registered the name, specification, batch number, quantity, the period of validity, production enterprises, distribution, transportation, license plate number, and arrival time of shipment, transportation temperature record information, shipping and receiving inspection personnel shall sign.
(2) vaccination units in providing vaccination, it shall timely in the vaccination certificate, records the vaccination (book) on the varieties, specifications, batch number, time, inoculated unit of vaccine, vaccination personnel information.
(3) vaccine production enterprises, distribution enterprises, regional warehousing enterprises, disease prevention and control institutions and inoculations should take the information means to accelerate the construction of the vaccine traceability system.
Third, strengthen the effective management of vaccine
Vaccine production enterprises, distribution enterprises, regional warehousing enterprises, disease prevention and control agencies and inoculations should effectively strengthen the management of the vaccine and prevent expired vaccines from entering the use link.
(a) the vaccine production enterprise in vaccine sales, to outbound order according to the production date of delivery, for the validity of the vaccines to the implementation of early warning management, cannot be valid within the term of delivery to the vaccine inoculation unit must not enter the circulation.
(2) the vaccine manufacturers shall ensure that the expiration date of the vaccine minimum packaging unit is clearly visible. Encourage vaccine manufacturers to use ink-ink-jet method to mark the production date, batch number and expiration date on the vaccine's smallest packaging unit.
(3) of institution of disease prevention and control and the vaccination units shall, in accordance with the type of vaccine, the classification of the validity of sequential vaccine pattern, and to establish a system for vaccine validity check, regularly check the validity of the vaccine, for an expired vaccine to isolated storage, and labeling "overdue" warning signs. Expired vaccine recycling, unification of institution of disease prevention and control at the county level shall register and regularly report to the food and drug supervision department at the county level expired vaccine varieties, batch number, quantity, production enterprises, the food and drug supervision departments at the county level shall jointly with the family planning administrative department of public health at the same level shall, in accordance with the regulations, supervising the destruction, destruction of records.
Fourth, further improve the centralized procurement of vaccines
(a) each of institution of disease prevention and control at the provincial level shall as soon as possible to purchase vaccine into provincial public resources trading platform management, according to the open and transparent, competitive, and the principle of fair trade for centralized purchasing online. To develop a vaccine procurement plan according to the need for vaccination; To collect and summarize vaccine procurement plans in the administrative region; After the provincial disease prevention and control agency summarizes the vaccine demand in the region, it forms a reasonable purchase price through direct network, tendering or negotiation and negotiation of the provincial public resource trading platform. Of institution of disease prevention and control at the county level shall, in accordance with the requirements and the tender result to the vaccine production enterprise purchasing vaccines, purchase quantity should guarantee within their respective administrative areas more than 2 to 3 months regular usage, and timely provide vaccination units in the region.
(2) the collectivization of vaccine production enterprises, the group company can be unified bidding on behalf of the vaccine production enterprise, purchase and sale contracts on behalf of the vaccine production enterprise, is responsible for the after-sale service work, and bear corresponding responsibility.
Strengthening the supervision and inspection of vaccine circulation
The food and drug supervision departments at all levels shall, in accordance with the drug supply quality management regulations "vaccine storage and transportation management specification" requirements for vaccine production enterprises, regional warehousing, distribution enterprises the main transportation, regional warehousing, distribution for inspection; Food and drug supervision departments at all levels, health, family planning administrative department according to their respective functions in accordance with the "vaccine storage and transportation management norms" of institution of disease prevention and control, vaccinated against unit quality assurance and vaccine storage transportation management supervision and inspection.
(a) the provincial food and drug regulators should regularly arranged for vaccine production enterprises, distribution, regional warehousing enterprises daily inspection, special inspection or flight check, in conjunction with the family planning administrative department of public health at the same level of institution of disease prevention and control, vaccination units implement daily inspection, special inspection or check flight. We will focus on the inspection of illegal and illegal practices in the storage and transportation of vaccines and make public the inspection results in accordance with the provisions. In accordance with the relevant provisions of the regulations on the administration of vaccine circulation and prevention and control of drug medical devices, the relevant provisions of the regulations on the administration of drug control and prevention of drugs shall be dealt with.
(2) the supervision and inspection of the main line of the vaccine line shall be responsible for the supervision of the food and drug administration at the place where the vaccine manufacturer is located; The supervision and inspection of regional storage and distribution of vaccines shall be carried out by the food and drug administration of the above municipal level. At the county level of institution of disease prevention and control, transportation, storage, such as unit of vaccine, link vaccine quality supervision and inspection of institution of disease prevention and control is located at the county level shall the food and drug supervision department at or above the county level, responsible for family planning administrative department of public health. The drug regulatory departments of the localities where the vaccines are produced, stored, transported and used each link shall cooperate with each other to supervise and inspect the work.
(3) the vaccine production enterprise, regional warehousing, distribution enterprise and institution of disease prevention and control, the vaccination units violation behavior in accordance with the pharmaceutical administration law of the People's Republic of China regulations on the administration of the circulation of vaccines and vaccination, and relevant regulations.
Family planning administrative department of public health and food and drug regulatory departments at various levels should cooperate closely and close collaboration, coordination mechanism set up joint supervision and inspection, timely communication vaccine distribution and use of information, form the joint effort, the circulation of vaccines and vaccination each work earnestly.
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