In 2020, are these things medicine people ready to deal with?

[industry trends of pharmaceutical network] measures for supervision and administration of pharmaceutical production (Draft for comments), which stipulates annual report, variety file, site management document, registration of production site, etc., aims to establish a scientific, strict and efficient pharmaceutical production supervision system, regulate drug registration behavior, and ensure the safety, effectiveness and quality control of drugs To establish an annual report system for drug marketing license holders In terms of "annual report", it is clear that the holders of drug marketing license shall establish an annual report system, report the changes in drug production process, production and sales, adverse reaction monitoring, post marketing research, risk management, etc every year according to the regulations, and summarize them to the drug variety file by means of information In addition, the holder of the vaccine marketing license shall make an annual report to the SDA in accordance with the provisions For the data of drug variety archives, it is necessary to maintain and update the "variety archives" related to the enterprises engaged in drug production activities, and maintain and update the data of drug variety archives to ensure that the whole process of drug production continues to meet the legal requirements Production and inspection records shall be complete and accurate, and shall not be fabricated or tampered with The legal representative and main person in charge of the drug listing license holder shall be fully responsible for the quality of the drug, including ensuring the authenticity, accuracy and timely update of the drug variety file For the change of production site, it is necessary to report relevant "site management documents", including: the auxiliary materials approved by the association, the packaging materials and containers of drugs directly contacted by the manufacturer, it is necessary to timely report the change of production process prescription or production site to the associated drug marketing permit holder, as well as the relevant requirements of drug annual report, etc Where the production site needs to register the "registration of production site" in the files, the measures make it clear that for those engaged in drug production activities, the extract of traditional Chinese medicine and the related approved APIs shall be registered , auxiliary materials, packaging materials and containers in direct contact with drugs shall be audited by suppliers or manufacturers to ensure that the purchase and use meet the specified requirements, and the production site registration shall be completed in the drug variety file according to the relevant requirements In addition, the legal representative and main person in charge of the drug listing license holder shall complete the registration of the production site in the drug variety file according to the relevant requirements, and cooperate with the drug regulatory department in the extended inspection of the drug listing license holder and related parties At present, are the pharmacists ready? It can be seen that under the promotion of the new drug production supervision and management measures, the supervision of drug production management will become more stringent in 2020 So in the face of the new situation, are the quality staff of pharmaceutical enterprises ready? At present, medical people have expressed their state, "it seems that they are not ready for anything, and they don't know anything." "When will it be implemented and to what extent? Panic a batch of "" but also to arrange people, perennial production of nearly 100 varieties, how to report? " Most of the medical people said they would wait for the implementation rules to be implemented Drugs are special commodities, which are related to human health and safety For pharmaceutical people, with the continuous improvement of drug production management requirements, what needs to be done is to strictly manage production according to the standards Although the process may be full of challenges, it is also an important way to ensure the safety, effectiveness and quality control of drugs.