Regulations on approval of pharmaceutical entrusted production will be issued, and technical examination will be strengthened

Source: great wisdom ashdak news agency November 19, 2013 In order to standardize the entrusted production of drugs and ensure the quality of drug production, the State Food and Drug Administration issued the regulations on the administration of the approval of the entrusted production of drugs (Draft for comments) (hereinafter referred to as the "opinions") to formulate regulations on the management of the entrusted production of drugs, strengthen the technical requirements of the entrusted production of drugs and clarify that the legal responsibility for the quality of drugs shall be borne by the entrusting party The opinions has strengthened the technical requirements for the examination and approval of pharmaceutical entrusted production According to the opinions, the provincial food and drug administration where the entrusting party is located shall organize the acceptance and examination of the application materials for drug entrusted production Based on the current measures for the supervision and administration of drug production, it is emphasized that for the first application for drug entrusted production, the entrusted production site shall be inspected, and the production conditions, technical level and quality management of the entrusted party as well as the entrusted production shall be mainly examined The consistency between the prescription, production process and quality standard of the drug and the entrusting party In fact, strengthening the technical review of drug commissioned production has been called for by the industry The industry insiders pointed out that the existing laws and regulations on the administrative requirements of the entrusted production approval link are more specific, but the technical requirements are very few, resulting in many risks and hidden dangers in the existing drug entrusted production The opinion specifies that the legal responsibility for drug quality shall be borne by the entrusting party The entrusting party shall confirm that the entrusted party has the conditions and capacity for entrusted production Meanwhile, during the entrusted production, the quality and technical personnel shall be dispatched to effectively supervise the production management and quality control of the entrusted party, so as to ensure the quality of the entrusted drugs This also makes the responsibilities of the entrusting party clearer It is worth noting that the implementation of MAH system in drug entrustment, which was called for during the two sessions this year, has not been released in the opinions Mah system refers to the management mode of separating marketing license and production license Whether drugs can be listed or not is not necessarily related to whether MAH has production license, which is very common in foreign countries However, China has always stressed that "the entrusting party should be the pharmaceutical manufacturer that has obtained the approval documents for the entrusted production of drugs", and this opinion is still not released The Opinions also pointed out that narcotic drugs, psychotropic drugs, pharmaceutical precursor chemicals and preparations, biological products, multi-component biochemical drugs, traditional Chinese medicine injections and APIs containing pharmaceutical precursor chemicals shall not be entrusted for production; the entrusted production of radioactive drugs shall be handled in accordance with relevant laws and regulations The State Food and drug administration may, according to the needs of supervision and administration, adjust the drugs that may not be commissioned for production.