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Recently, the website of Hebei Provincial Drug Administration issued a notice on promoting the traceability of pharmaceutical tablets in the drug circulation traceability system (hereinafter referred to as "Notice"), which incorporated a batch of Chinese medicine tablets into the drug circulation traceability system, including the implementation of the Chinese Pharmacopoeia and the Ministry of Health's Drug Standards. The first volume of Chinese herbal medicine, the 2003 edition of the Hebei Provincial Chinese Medicine Drink Tablets Manufacturing Code, the 2018 edition of the Hebei Provincial Chinese Medicine Standards, and other Chinese medicine tablet varieties involving the operation of wholesale enterprises.
, it is worth noting that the Hebei Provincial Drug Administration has also selected 20 pharmaceutical wholesale enterprises to carry out standard data control and traceability data upload of Chinese medicine tablets.
and will need to complete the control and retrospective data upload of Chinese medicine tablet varieties on August 12, 2020.
fact, in recent years, China's Chinese medicine tablets industry market has been expanding.
, but at the same time, non-conforming drugs have been frequently exposed, becoming a regular visitor to the drug regulatory authorities, seriously affecting the development of the industry.
situation, how to ensure the safety and effectiveity of Chinese medicine tablet products, quality control, has become an urgent problem to be solved in the industry.
However, due to the long industrial chain in the production of Chinese medicine tablets, from seed seedling, medicinal cultivation, harvesting, processing to packaging storage, transportation, each link is related to the quality of Chinese medicine tablets.
, in order to ensure quality and safety, improve consumer confidence in Chinese medicine, the establishment of product traceability system and quality assurance system is of great significance.
industry believes that the quality traceability system of Chinese medicine must be traced from the beginning of the cultivation of medicinal herbs, especially the traceability system of the cultivation of medicinal herbs, from the environment, farmers, planting, harvesting, processing and other complete processes.
At the same time, but also to the Chinese medicine drink tablets of the production link trace, the procurement of raw materials, feeding, inspection, packaging and other whole process traceability, thus forcing enterprises from the source of good quality and safety of Chinese medicine.
in recent years, the relevant departments have been strengthening the supervision of drugs, and the construction of drug traceability system has a long history.
august this year alone, two more documents were issued on the implementation of the drug quality traceability system.
26, the newly amended Drug Administration Act was passed by a vote and will come into effect on December 1, 2019.
, Article 32 of the newly revised Drug Administration Law clearly states that drug market license holders, pharmaceutical manufacturers, pharmaceutical enterprises and medical institutions shall establish and implement a drug quality traceability system to ensure drug traceability.
August 27, the State Drug Administration issued three information standards, such as the Basic Technical Requirements for Drug Trace Systems, and said they would be implemented from the date of publication.
the basic technical requirements of drug traceability system, drug traceability system should have the function of providing drug traceability information query to consumers and providing trace data query function to regulators.
, from the policy trend, whether it is Chinese medicine tablets or other drugs, with the deepening of drug traceability system construction, the future face of the industry supervision will be more stringent.
for all pharmaceutical companies, what needs to be done is to be practical, according to the norms of the production of drugs, the quality of drugs raised, to ensure that patients use drugs more effectively and safely.
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