Medical network - on February 27, 2016, shandong province since the "3.18" vaccine case, all work related and drug traceability system has become more urgent. CFDA on July 20, 2016 issued "on the modified < drug management quality management > decision", definitely require drug manufacturers in drug purchase, storage, sale, transport, in accordance with the relevant state requirements, establish the traceability system, realize the drugs can be full traceability. Recently, the seven ministries jointly issued a Chinese herbal medicine circulation is traceability system, traditional Chinese medicine (TCM) industry to meet good again!
▍ drug traceability system for specific guidance on the ground
On February 23, the ministry of commerce released the official website of the ministry of commerce, the CFDA seven ministries and commissions such as on the promotion of the construction of important product information tracing system guidelines "(hereinafter referred to as" guidelines "), the deployment of important product information tracing system construction work.
Drug traceability system construction is the important content in the "guidance", clearly put forward to establish the traceability management mechanism. "Promote drug production and circulation enterprises to carry out the principal responsibility, according to the laws and regulations and national standards, the use of information technology acquisition retained the information such as sources of raw materials, production process, the purchasing records, to ensure the traceability of the drug. Enlarge the coverage of drug traces the regulation, gradually achieve all drugs from production, circulation to use back quickly."
Yesterday (24 February), wu zhen, deputy director of the CFDA attend a national conference on drug sampling in chengdu speech also mentioned that this year's drug sampling observation is one of the important work constantly enhance the level of inspection and found problems, explore the achievements of inspection method, inspection results into regulatory means. Strengthen inspection personnel team construction, improve the innovative ability of test method. Inspection institutions should further perfect its own quality management system, to ensure the integrity of survey data, reliable, and traceable.
▍ Chinese herbal medicine production and sales traceability system to upgrade again
Now people often say "destroyed by traditional Chinese medicine of traditional Chinese medicine", although some of the extreme, but it's not truth. The main reason lies in lack of traceability system in the whole process of the traditional Chinese medicine industry chain system, the quality of medicinal materials decline, associated with reduced the clinical effect of Chinese medicine yinpian, proprietary Chinese medicine.
"Guidance" to consolidate the traditional Chinese medicine circulation tracing system is put forward. Upgrading of traditional Chinese medicine circulation traceability management central platform, promote the different drug traceability system information sharing. Gradually increase the traditional Chinese medicinal materials traceability varieties; Gradually expand the coverage, covers the main traditional Chinese medicine wholesale market in the region; Improve the Chinese herbal medicine planting cultivation, management, human diseases and production management main body, the medical institutions and pharmacies node coverage. After further perfection of Chinese medicinal materials traceability system, to further strengthen the Chinese herbal medicine planting, production, distribution regulation of each part.
In recent years, the CFDA and local food and drug supervision and administration bureau continuously strengthen traditional Chinese medicine and Chinese medicine yinpian, advertisements such as drug inspection offices in guangdong province, this month 23, 22 23 Chinese medicine yinpian unqualified batch production. Sampling observation of drug administration departments at different levels can strengthen the sampling inspection of traditional Chinese medicine and Chinese medicine yinpian, repeatedly and notify the enterprises that violate the rules, and benefit from the Chinese medicinal materials traceability system system, quickly found a violation of enterprise and the unqualified products.
Chinese herbal medicine circulation tracing system is our country medicine industry, the earliest construction is the most mature of traceability system in the field of medicine industry, pointed out in the guidance, to further upgrade and improve circulation of Chinese traditional medicine production traceability system, gradually expanding the scope of the back cover, from the seed seedlings, herbs source to medicinal herbs planting, picking and processing, circulation are to realize the traceability, in order to improve the quality and effect of Chinese medicine products provide the basis, the name for the Chinese medicine industry, break the people for "" of traditional Chinese medicine was destroyed by the ideas.
▍ all industry chain layout of big business enterprise of traditional Chinese medicine is good
Civilization, deputy director of the state administration of traditional Chinese medicine in Chinese medicine related BBS said, "at present, the development of traditional Chinese medicine a rare period of strategic opportunities." Since 2016, a series of blockbuster to support development of traditional Chinese medicine in our country's good policy has issued, it is not difficult to expect in the next few years, traditional Chinese medicine (TCM) industry in China will gradually enter the dividend policy implementation phase.
"Guidance" tuned to consolidate the traditional Chinese medicine circulation tracing system is put forward, on the surface is to strengthen the regulation of traditional Chinese medicine (TCM) industry related enterprises, but in the long run more conducive to the increase of concentration of traditional Chinese medicine industry, promote the development of whole industry chain of traditional Chinese medicine.
The domestic some strength, the whole industry chain layout form of development of traditional Chinese medicine enterprises form the positive, because the middle and lower reaches of these enterprises through the whole industry chain control, not only realized the full traceability, form a safe and effective supply chain process, also can strengthen the enterprise to each link of cost control, enhance the level of corporate profits. Has a complete industrial chain of traditional Chinese medicine enterprise layout will have a strong ability to adapt to all kinds of strict national policy regulation, will also take the lead in further developing in the process of regulation, enterprise mergers, eliminated the strength is not strong.
Traceability system of traditional Chinese medicine industry will upgrade and means to further strengthen regulation, small and medium-sized Chinese medicine enterprises ready to ready to meet the challenge? |
