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1, 20 pharmaceutical enterprises, began to trace Chinese medicine tablets september 18, Hebei Provincial Drug Administration issued "on the Chinese medicine tablets into the scope of drug circulation retrospective notice", further deployment of Chinese medicine tablets traceability work.
notice shows that, in accordance with the General Office of the State Council "on accelerating the construction of an important product traceability system" "2020 to build a seven-category key product traceability system, including drugs", and the State Administration of Drug Administration "guidance on the construction of drug information traceability system" requirements, in August this year, Hebei Province In the country to take the lead in exploring the chinese medicine tablets into the drug traceability system, identified the first batch of Chinese medicine tablets into the drug circulation traceability system varieties and traceability data standards, and selected 20 pharmaceutical enterprises to carry out chinese medicine tablets standard data control and traceability data trial upload work.
In accordance with the requirements, the enterprises that implement the retrospective data upload of Chinese medicine tablets are the selected 20 pharmaceutical tablet production enterprises, all Chinese medicine tablet franchise enterprises, as well as pharmaceutical wholesale enterprises and pharmaceutical retail enterprises that have joined the drug circulation traceability system.
first batch of Chinese medicine tablet production pilot enterprises and Chinese medicine tablet franchise enterprises should be registered in Hebei Province by October 15, 2020 drug traceability system.
to gradually promote other Chinese medicine tablets production enterprises to join the drug circulation traceability system.
After the pilot enterprise and franchise enterprise realize the data transmission interface docking, the cost-generating enterprise purchases, sells and stocks XML data files of Chinese medicine drink tablets, and automatically uploads data to the drug circulation traceability system on a daily basis.
November 1, 2020, the province's pharmaceutical enterprises officially reported traceability data of Chinese medicine tablets.
pharmaceutical enterprises shall ensure that the reported data are true, complete and accurate, and shall not refuse to report, falsely report, conceal or delay the report.
the first batch of Chinese medicine beverage tablets to join the drug circulation traceability system of the list of production enterprises: 2, Chinese medicine tablets, the quality gradually improved for Chinese medicine traceability, is not a new topic.
as early as April 2015, the Protection and Development Plan for Chinese Herbal Medicines (2015-2020) regards the establishment of a full-process traceability system covering the main varieties of Chinese herbal medicines as an important task in building a quality assurance system.
requires the establishment of a traceability system of Chinese herbal medicines from cultivation and breeding, processing, acquisition, storage, transportation, sales to use the whole process, to achieve the source can be traced, to be traceable, responsibility can be investigated, to promote the use of production enterprises with a clear source of Chinese herbal medicine raw materials.
, in recent years, a number of relevant departments have been promoting the cultivation base, storage and circulation of medicinal materials, such as standardization, to ensure the quality of medicinal herbs.
construction of the circulation traceability system of Chinese herbal medicine is one of them.
, in recent years, the state's supervision of Chinese medicine tablets has also continued to increase.
Since the release of last year's newly revised Drug Administration Law, the industry has generally said that Chinese medicine tablets enterprises are getting worse and worse, in 2019 the industry in the direction of high-quality development, some small and medium-sized beverage tablets enterprises do not have production standards are accelerating out of the market.
According to the report released by the Chinese Medicine Variety Alliance analysis, in the regulator's strong attention and active efforts of the industry, in recent years, the quality of Chinese medicine tablets has made great progress, sampling pass rate gradually increased (from 64% in 2013 to 91% in 2019), the past doping to make false, weight-gaining dyeing and other malicious violations have been effectively curbed.
However, due to the huge volume of Chinese medicine tablets (as of October 2019, according to the State Drug Administration database, China's existing listed drug approval 166668, but the total product regulations of drinking tablets conservatively estimated at more than 800,000, far more than the sum of various types of drugs) and the market is extremely dispersed, The quality of Chinese medicine tablets is more prominent or "showing" outstanding situation.
With the implementation of the newly revised Drug Administration Law, the 2020 edition of the Pharmacopeia will also be implemented on December 30 this year, coupled with the origin of Chinese medicine, Chinese herbal medicine and its beverage tablet products continue to increase heavy metals and 33 agricultural residues testing into reality must face the problem, the relevant Chinese medicine tablet enterprises if they can not follow up in time or prepare for the rain, it will be difficult to survive.
we can also see that in a series of policy combination, the quality of Chinese medicine is gradually changing, the future will be better and better.
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