In order to standardize the entrusted production of drugs and ensure the quality of drug production, the State Food and Drug Administration promulgated the "Administrative Regulations on the Examination and Approval of Drugs Commissioned Production (Draft for Comment)" (hereinafter referred to as "Opinions"), which stipulates the formulation of examination and approval management of drug entrusted production and strengthens the entrusted production of drugs. The technical requirements of the examination and approval link and the legal responsibility for clarifying the quality of the drug shall be borne by the entrusting party. The "Opinions" strengthens the technical requirements for the commissioning of drug commissioning. The "Opinions" pointed out that the provincial food and drug administration of the country where the entrusting party is located organizes the examination and approval of the application materials for drug commissioned production, and on the basis of the current "Administrative Measures for the Supervision and Administration of Pharmaceutical Production", it emphasizes that the first application for commissioned drug production should be subject to trust. The inspection shall be conducted at the production site to focus on assessing the production conditions, technical standards, and quality management of the consignee, as well as the drug prescriptions, production processes, and quality standards of the entrusted party and the consistency of the entrusting party.
In fact, the technical review of enhanced commissioned production has been the industry's call. Industry insiders pointed out that the existing regulations stipulate more specific administrative requirements for the entrusted production examination and approval procedures, and there are few technical requirements, resulting in the existence of many hidden risks in the existing pharmaceutical commissioned production.
The "Opinions" clarified that the legal responsibility for the quality of drugs is borne by the entrusting party. The entrusting party shall confirm that the consignee has the conditions and capabilities for entrusted production, and at the same time, during the entrusted production period, it shall send quality technical personnel to effectively supervise the production management and quality control of the entrusted party so as to ensure the quality of entrusted production of pharmaceuticals. This also makes the principal's responsibility more clear.
It is worth noting that during the two sessions of the year, the “MAH†system for implementing the Drug Listing Permit Holder (MAH) was not released. The MAH system refers to the management model that separates the marketing license from the production license. Whether the drug can be listed on the market is not necessarily related to whether the MAH has a production license, and it is very common in foreign countries. However, the domestic government has always emphasized that “the entrusting party should be a pharmaceutical manufacturing company that has obtained the approval document for entrusting the production of pharmaceuticalsâ€, and this opinion has still not been let go.
The "Opinions" also pointed out that narcotic drugs, psychoactive drugs, pharmaceutical precursor chemicals, pharmaceutical preparations containing precursor chemicals, biological products, multi-component biochemical drugs, Chinese medicine injections, and APIs must not be commissioned for production; The entrusted production of drugs shall be handled in accordance with relevant laws and regulations. The State Food and Drug Administration may adjust the pharmaceutical products that may not be commissioned in accordance with the needs of the supervision and management work.
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Luoyang Haloxylon Ammodendron Medical Device Co., Ltd. was founded in 2019, is a professional engaged in medical devices, home medical devices and related health products, product development and sales as one. The factory strictly implements ISO 13485 standard, all products are in line with medical CE standard. At present, our business has a sound economic foundation and strong relationship network, many new traders in Europe, America, Australia and China have appointed us as their sole agent. Perfect technology and personnel allocation, in solving all kinds of solutions for customers at the same time, but also for customers to explore the Chinese market, find sources of goods, accept sources of goods, and for the enterprise carefully create professional, personalized, all-weather, all-round one-stop service. In mainland China, we have a very efficient import and export service system and we work closely with many shipping companies and airlines. For the export of your goods, we can provide you with the best shipping, air transportation, customs clearance, insurance and other services. At present, the company's trade scale is expanding day by day, customers all over the world, and with good reputation, won the trust of customers at home and abroad, to promote China's modernization, promote economic and technical exchanges with the world, to enhance the friendship with the people of all countries have done a lot of useful work. If you need more information, please feel free to contact us
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