Seven ministries issued: the national drug tracing

Since the "3.18" vaccine case in Shandong Province in 2016, the work related to the drug traceability system has become more urgent. On July 20, 2016, the CFDA issued the Decision on Modifying <>, which explicitly requires pharmaceutical manufacturers to establish drug traceability systems in accordance with the relevant national requirements in the procurement, storage, sale, transportation and other aspects of drug procurement, storage, sales, transportation, etc., so as to realize the full traceability of drugs. Recently, the seven ministries jointly issued a strong chinese medicine circulation traceability system, the Chinese medicine industry again welcome good!Dration traceability system construction specific guidance landed
On February 23, the official website of the Ministry of Commerce officially released the Ministry of Commerce, CFDA and other seven ministries "guidance on promoting the construction of important product information traceability system" (hereinafter referred to as "guidance"), the deployment and promotion of important product information traceability system construction work.
drug traceability system is an important part of the Guidance, and it is clearly proposed to establish a drug traceability management mechanism. "To promote pharmaceutical production and circulation enterprises to implement the main responsibility, in accordance with laws and regulations and national standards, the use of information technology to collect retained raw material sources, production processes, purchase and sale records and other information to ensure the traceability of drugs." Expand the scope of drug traceability supervision, and gradually realize the rapid traceability of all drugs from production and circulation to use.
Yesterday (February 24), CFDA Deputy Director Wu Wei attended the National Drug Sampling Work Conference in Chengdu, also mentioned that one of the important work of this year's drug sampling is to continuously improve the level of testing and the ability to detect problems, explore the results of the testing method transformation, so that the test results into a means of supervision. Strengthen the construction of inspection personnel, improve the ability to establish innovative test methods. Each inspection institution should further improve its own quality management system to ensure the integrity, reliability and traceability of inspection data.The traceability system for the production and sale of Chinese herbal medicines will be upgraded again
The main reason is the lack of a traceability system system for the whole process of the Chinese medicine industry chain, the quality of medicinal herbs has declined, and the clinical effects of Chinese medicine tablets and Chinese medicine have been greatly reduced.
"Guidance" proposed to consolidate and enhance the circulation of Traditional Chinese medicine traceability system. Upgrade and transform the central platform for the management of the circulation traceability of Chinese herbal medicines, and promote the exchange and sharing of information among different drug traceability systems. Gradually increase the retrospective varieties of Chinese herbal medicines, gradually expand the coverage, covering the main wholesale markets of Chinese herbal medicines in the region, improve the cultivation and cultivation of Chinese herbal medicines, management, drink tablets and Chinese medicine production and operation of the main body, medical institutions and pharmacies and other nodes coverage. After further improving the traceability system of Chinese herbal medicine, we can further strengthen the supervision of all aspects of the cultivation, production and circulation of Chinese herbal medicine.
In recent years, CFDA and the local General Administration of Food and Drug Administration have continuously strengthened the sampling of Chinese herbal medicine and Chinese medicine tablets, such as the 23rd of this month in Guangdong Province Drug Inspection Institute, 22 enterprises produced 23 batches of Chinese medicine tablets are not qualified. The sampling agencies of the Drug Administration at all levels can strengthen the sampling of Chinese herbal medicine and Chinese medicine tablets, repeatedly found and notified the violation of the enterprise, thanks to the Chinese medicine traceability system system, quickly found that there are violations of the enterprise and unqualified products.
The traceability system of the circulation of Chinese herbal medicines is the earliest and most mature traceability system in the field of pharmaceutical industry in China, and the Guidance points out that it is necessary to further upgrade and improve the traceability system of the production and circulation of Chinese herbal medicines, and gradually expand the traceability coverage.In present, the development of Chinese medicine is facing a rare period of strategic opportunity
, " Yu Civilization, deputy director of the State Administration of Traditional Chinese Medicine, said at a forum related to Chinese medicine. "Since 2016, a series of good policies to support the development of Chinese medicine have been issued, it is not difficult to predict that in the next few years, China's Chinese medicine industry will gradually enter the stage of achieving policy dividends.
"Guidance" proposed to consolidate and enhance the circulation traceability system of Traditional Chinese medicine, on the surface is to strengthen the supervision of the Chinese medicine industry-related enterprises, but in the long run more conducive to the concentration of the Chinese medicine industry to improve the promotion of the development of the entire industrial chain of Chinese medicine.
This is good for the development and growth of some powerful Chinese medicine enterprises with the whole industrial chain layout, because these enterprises through the whole industry chain upstream and downstream control, not only realize the whole process of traceability, the formation of a safe and effective supply chain, but also strengthen the enterprise's cost control of all links, improve the profit level of enterprises. Chinese medicine enterprises with the layout of the whole industrial chain will have a strong regulatory capacity to adapt to various strict policies of the country, and will take the lead in the regulatory process to further develop and develop, mergers and elimination of those enterprises that are not strong.
chinese medicine industry's traceability system will be upgraded again, which also means that the further strengthening of supervision, small and medium-sized Chinese medicine enterprises are ready to meet the challenge? (Pharmaceutical Network)