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| The holder may produce, sell and sell the drugs on its own or by commission |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-22 11:23:17 Number Browse：661 |
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On August 21, August 21, the CFDA official website issued a notice concerning the implementation of the pilot work on the implementation of the approval of the licensing system for drug listing. The following items were clearly stated:
1. Implement the legal responsibility of the holder.
Holder is responsible for the whole life cycle of drugs production and sales of the whole chain and drugs administration, the drug preclinical research, clinical trials, manufacturing, distribution and distribution, adverse reactions monitoring bear all legal responsibilities. Drug manufacturers, drug research and development institutions and researchers may be holders. Pharmaceutical producing and processing enterprises that do not possess the approval of drug approval Numbers but have the drug production license may be entrusted with the production and processing of pharmaceuticals. The units and individuals entrusted by the holder to undertake research and development, clinical trials, manufacturing and distribution of the products shall bear the responsibilities of the provisions of the laws and regulations and the obligations stipulated in the agreement. Released by the holder is responsible for the products listed, take full responsibility for sale of drug quality, entrusted production enterprise is responsible for the process and in the agreed quality standard production, responsible for the production release, the holder of the corresponding quality responsibility. The entrusting party and the agent shall sign a specific entrustment agreement to clarify the rights and obligations such as technical requirements, quality assurance and liability division of the production.
Ii. Integrate technical resources and promote specialized scale production.
The pharmaceutical production enterprise group can centralize the approval of the drug approval of each holding subsidiary to the group company and become the holder. Group company according to each subsidiary production and processing capacity will be prepared in the product integration, making each unit has a characteristic, advantage, scale of production base, unified group of each subsidiary of the quality management system, group company take full responsibility for the quality of all listed products. On the group company holds a drug approval number, provincial food and drug regulatory review where the transferee is located, the food and drug supervision bureau for approval, product roll-out party local food and drug supervision departments to give support.
Drug production and processing site or plant relocation within long-distance move, can keep the document of approval for drugs in the original enterprise hold, production management, technical standards, product quality is consistent with the original production enterprise, or production workshop production by new production and processing enterprises. Overall relocation or merger after the overall relocation, the original enterprise become the holder, the holder of the local provincial food and drug regulators to production enterprises put forward application, technology review, on-site inspection, sample inspection application, and the location of the newspaper after the provincial food and drug regulatory authorities for examination and approval of the food and drug supervision bureau for record (biological products shall be reported to the food and drug supervision bureau to carry out the technical review and administrative examination and approval). The registered production site inspection of the pilot varieties is carried out with the on-site inspection of drug GMP certification.
Manufacturers of pharmaceutical research and development agencies can transfer drug approval Numbers to drug research and development institutions, and drug research and development agencies as holders to make the production.
When filing in the above adjustments, the enterprise shall be in accordance with the relevant provisions of the food and drug regulators to the food and drug supervision bureau truthfully submit the drug prescription, production technology, raw materials, packaging materials and the registration of a full set of product quality standard file.
3. Allow the holder to delegate more production.
The holder shall establish the drug quality management system. Under the premise of ensuring the consistency of drug quality and efficacy, the holder is allowed to apply for more than one enterprise. After receiving the first batch of production, the holder may then entrust other production enterprises to produce and manufacture the products. The products entrusted to be processed must be in accordance with the prescription, process and quality, and the holder shall bear all legal liabilities. Approval for more varieties of pilot production, in the drug approval documents issued by the approval number 1, separately listed related production enterprise name, address, and a trustee in the drug labels, specifications indicate the specific information such as production company name and address. Drug production and processing enterprises must strictly implement the drug GMP regulations and accept supervision from the supervision department.
4. Allow the holder to sell the medicine on his own or in commission.
The pharmaceutical research and development institutions and scientific researchers may sell their medicines on their own, but they shall have the capacity and conditions for the operation of drugs prescribed by the drug administration law. It may also entrust a pharmaceutical producing enterprise or a drug-handling enterprise with a drug-handling license to sell drugs. When entrusted to sell drugs, a contract shall be signed to clarify their respective rights, obligations and responsibilities, to comply with relevant laws and regulations, and to implement drug traceability and quality management responsibilities. The holder should master the quality information and adverse reactions in the process of drug circulation, recall the medicine when quality problems occur, and control in time. All pharmaceutical enterprises must strictly implement the relevant requirements of the quality management standard of pharmaceutical products (GSP), and improve the quality management system and risk control system of the circulation link.
V. to accelerate the examination and approval of the registered varieties of the pilot enterprises.
For this notification requirements of the entrusted production pilot provinces selection is proposed to carry out varieties of applications, conform to the food and drug supervision bureau about addressing drug registration for priority review backlog of examination and approval opinions "(food drug safety medicine tube [2016] no. 19), the applicant can apply administration of state food and drug supervision and administration of drug approval center into priority review for examination and approval, its development site verification, the clinical trial data verification, production site inspection, sample inspection, and give priority to deal with drug GMP certification, etc.
In the evaluation of the quality and efficacy of generic drugs, the holder of the drug approval document may apply to be the holder when submitting the application for conformance evaluation. The general administration of food and drug administration (fda) has approved the approval of a consistent assessment of the holder.
6. The holder shall carry out drug alert and annual report.
The holder should establish a drug alert system. Holder shall, in accordance with the "adverse drug reaction report and monitoring measures for the administration of the relevant requirements, to carry out the adverse drug reaction monitoring, continuous inspection of post-marketing drug safety and efficacy of drugs of the identified risk is risk control measures in time, report directly to the food and drug regulatory authorities in the clinical adverse reaction and disposal measures. The holder may cooperate with the relevant third party to carry out the drug warning of the pilot varieties, but not exempt from the obligations and responsibilities of the holder.
Within 20 working days after the end of each year, the holder shall report to the general administration of food and drug administration of drug production, sales, prescription, process, drug alert and quality control measures.
The drug production enterprises in the pilot area may refer to the pilot content management.
The drug production enterprise which holds the approval of drug approval may apply for the pilot project commissioned by the holder, which shall be carried out in accordance with the relevant provisions of the relevant regulations of the provincial food and drug administration. The trial effect of the drug commissioning will be included in the work summary of the listed licensee.
Viii. Improve the drug regulatory responsibilities of the two countries.
The two food and drug regulatory agencies that are commissioned across the region should be well regulated. The provincial food and drug regulatory authorities where the listed licensee is located shall supervise the behavior of the entrusted production and the management of the products after the listing. Entrusted production of local food and drug regulators to monitor the production process and product quality, in the case of product quality problems or serious adverse reactions, both regulators coordinated and resultant force is investigated.
9. Actively explore the pilot model.
The pilot provinces (municipalities) food and drug regulators in the pharmaceutical marketing authorisation holder system pilot program "(countries do hair [2016] no. 41) and the notice requirements, on the basis of combining the local pharmaceutical producing enterprises and pharmaceutical research institutions, the actual situation of scientific research personnel, and actively explore pilot model accords with the practice of this province (city). The pilot provinces (municipalities) food and drug regulators to select several declare subjects as their test objects, to explore new drugs, consistency evaluation, the overall relocation, entrust production (not including holder production itself), and other modes of pilot work, and before the August 30, 2017 will be the pilot selection report the food and drug supervision bureau.
10. Timely summarize the pilot experience.
Pilot's goal is to establish and improve the holders and the trustee entrusts the production rights and obligations and the responsibility of the quality assurance system, set up perfect cross-regional supervision responsibility of supervision and inspection system and quality guarantee system, improve the system of the marketing authorisation holder. The food and drug administration of each pilot province shall promptly carry out the pilot work in accordance with this requirement and submit the interim summary of the pilot work in December 2017. The food and drug supervision bureau to strengthen the guidance of the pilot work, supervise the pilot work in progress, for the pilot work experience in a timely manner to promote, for lack of work, the food and drug supervision bureau will be notified as appropriate.
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