Chinese medicine traceability to 20 pharmaceutical enterprises began to pilot

On September 21, the source of Chinese medicine has come, 20 pharmaceutical enterprises have begun to pilot 1, 20 pharmaceutical enterprises have begun to trace the decoction pieces of traditional Chinese medicine.

On September 18, Hebei Provincial Drug Administration issued the notice on bringing Chinese herbal pieces into the scope of drug circulation traceability, further deploying the work of tracing Chinese herbal pieces. According to the notice, in accordance with the requirements of the "opinions on accelerating the construction of traceability system for important products" issued by the general office of the State Council, "to establish a traceability system for seven categories of key products including drugs" by 2020, and the "guiding opinions on the construction of drug information traceability system" issued by the State Drug Administration, Hebei Province took the lead in exploring the inclusion of Chinese Herbal Pieces in drug tracing in August this year In the traceability system, the first batch of Chinese Herbal Pieces varieties and traceability data standards included in the drug circulation traceability system were determined, and 20 drug trading enterprises were selected to carry out the work of standard data comparison and traceability data uploading.

According to the requirements, the enterprises implementing the traceability data upload of Chinese herbal pieces are selected 20 Chinese medicine decoction pieces production enterprises, all Chinese medicine decoction pieces monopoly enterprises, and drug wholesale enterprises and drug retail enterprises that have joined the drug circulation traceability system. The first batch of Chinese Herbal Pieces production pilot enterprises and proprietary enterprises of Chinese herbal pieces should be registered in the drug traceability system of Hebei Province before October 15, 2020. Gradually promote other manufacturers of Chinese herbal pieces to join the drug circulation traceability system.

After the data transmission interface is connected between the pilot enterprises of Chinese Herbal Pieces production and the exclusive enterprises, the XML data files of purchase, sales and inventory of Chinese herbal pieces are generated, and the data is automatically uploaded to the drug circulation traceability system every day. Since November 1, 2020, pharmaceutical enterprises in the whole province have officially reported the traceability data of Chinese herbal pieces. Pharmaceutical trading enterprises shall ensure the truthfulness, completeness and accuracy of the reported data, and shall not refuse to report, make false report, conceal report or delay in reporting. List of the first batch of Chinese Herbal Pieces manufacturing enterprises to join the drug circulation traceability system: 2. The quality of Chinese herbal pieces is gradually improved. As early as April 2015, the plan for the protection and development of Chinese herbal medicines (2015-2020) has regarded the establishment of the whole process traceability system covering the main varieties of Chinese herbal medicines as an important task in the construction of quality assurance system. It is required to establish a traceability system for the whole process of Chinese herbal medicine from planting, breeding, processing, purchase, storage, transportation, sales to use, so as to realize the traceability of source, destination and responsibility, and promote the use of raw materials of Chinese herbal medicine with clear source. In fact, in recent years, a number of relevant departments have been promoting the standardization of planting bases, storage and circulation of medicinal materials to ensure the quality of medicinal materials.

The construction of traceability system of Chinese herbal medicine circulation is one of the links. In addition, in recent years, the national supervision of Chinese herbal pieces has continued to increase. Since the release of the newly revised "Drug Administration Law" last year, the industry generally said that the life of Chinese medicine decoction pieces enterprises is becoming more and more difficult. In the development process of the industry towards high quality in 2019, some small and medium-sized decoction pieces enterprises that do not meet the production standards are accelerating to withdraw from the market.

According to the analysis of the report released by the alliance of large varieties of traditional Chinese medicine, with the strong attention of the regulatory authorities and the active efforts of the industry, the quality of Chinese herbal pieces has made great progress in recent years, and the qualified rate of sampling inspection has gradually increased (from 64% in 2013 to 91% in 2019). In the past, malicious violations such as fake and weight gain dyeing have been effectively curbed. However, due to the huge quantity of Chinese herbal pieces (as of October 2019, according to the database of the State Food and drug administration, there are 166668 drug approvals on the market in China, but the total product specifications of herbal pieces are conservatively estimated to be more than 800000, far exceeding the sum of all kinds of drugs) and the market is extremely scattered, so the quality problems of Chinese herbal pieces are more prominent or "showing" a prominent situation.

With the implementation of the newly revised "Drug Administration Law", the 2020 edition of the Pharmacopoeia will also be implemented on December 30, this year. With the traceability of traditional Chinese medicine, it is necessary to continue to increase the detection of heavy metals and 33 pesticide residues in Chinese herbal medicines and their decoction pieces. If the relevant enterprises of Chinese herbal pieces can not follow up in time or prepare for the rainy days, it will be difficult for them to survive. We can also see that under the combination of a series of policies, the quality of traditional Chinese medicine is gradually changing, and it will be better and better in the future.