The first batch of pharmaceutical standards for traditional Chinese medicine formulas introduced by the state

On April 29, the official website of the State Pharmacopoeia Commission released the "Notice on Matters Relating to the Implementation of National Drug Standards for Chinese Medicine Formulas". This is the first batch of 160 national drug standards for traditional Chinese medicine formula granules approved by the State Drug Administration. Since the end of the 28-year pilot work of Chinese medicine formula granules, the market has been fully liberalized without approval and can be produced and sold after filing, which is undoubtedly an opening for the development of Chinese medicine formula granules.

And the introduction of the Notice, for the Chinese medicine formula particles industry is also very meaningful. "This is a sign that the production of Chinese medicine formula particles in the country will be fully liberalized, will usher in a new opportunity for development. The original six pilot enterprises will also end the market 'policy monopoly', the national competition pattern is coming. Chinese medicine formula particles will become another big choice to fill the domestic preparation market after chemical drugs, biological preparations and proprietary Chinese medicines." Hong Jun, deputy general manager of Hebei Banzai Pharmaceutical Co.

Ltd. revealed to me that the 160 Chinese medicine formula granule standards introduced by the Notice have the following similarities: they are the most commonly used clinical varieties; they are completely state-led standards; they are "national level" Chinese medicine formula granule standards; and they are currently the It is the highest standard in the Chinese medicine formulation granule industry. According to the "Announcement on the End of the Pilot Work of Chinese Medicine Formula Granules", the corresponding standards formulated by the provincial drug supervision and management departments shall be abolished from the date of implementation. Obviously, there are far more than 160 kinds of Chinese medicine formula granules. In this regard, Hong Jun deduced that other formulas that are not covered remain in accordance with the provincial standards.

The Notice" pointed out that, in accordance with the "Notice on the end of the pilot work of Chinese medicine formula particles", the first "quality supervision of Chinese medicine formula particles into the management of Chinese medicine tablets" requirements, its standards related to pesticide residues, heavy metals and harmful elements, mycotoxins and sulfur dioxide residues, etc. are referred to the current version of the "Chinese Pharmacopoeia" Chinese medicine tablets The provisions of the Chinese Pharmacopoeia. After all, there are still some differences between the two, and it is inevitable that there are controversies about whether it is reasonable to refer to the quality standard of Chinese medicine drinking tablets for Chinese medicine formula granules. In Shen Yong's opinion, it is reasonable. The Chinese medicine formula granules are a kind of concentrated, dried and purified "advanced tablets" from the production process; from the efficacy is also a "highly similar to the drinking tablets", so essentially the Chinese medicine formula granules still belong to the Chinese medicine tablets. However, Hong Jun has a very different view, he thinks it is unreasonable from a theoretical point of view. Because the production process of ordinary tablets is relatively simple and rough, but the production of Chinese medicine formula granules has higher requirements in extraction and extraction, which is different from the production of tablets, and the change of process leads to the application of quality standards of tablets is unreasonable. Therefore, under the appropriate conditions to establish a separate implementation standard for Chinese medicine formula granules.

Obviously, the promulgation of the Notice signifies that the industry will have a unified standard in the future, which is a more standardized management for the "first entrants" and a protection for the "later entrants". According to data from the Foresight Industry Research Institute, the market size of Chinese medicine formula particles grew from 200 million yuan to 10.7 billion yuan from 2006 to 2016, with a compound annual growth rate of 48.9%, and the market size of Chinese medicine formula particles is expected to reach 25.5 billion yuan in 2020. Some institutions predict that the Chinese medicine formula granule industry will still maintain rapid growth in the next 5 years, and the industry scale is expected to reach 49.21 billion yuan by 2023. And Shen Yong predicts that a market volume of ≥100 billion will be achieved in the next 5 years. It can be seen that all parties are bullish on the Chinese medicine formula granule market.

With the introduction of unified standards, the problems that restrict the development of the industry, such as market confusion and wasteful duplication of R&D, will be solved. What is needed for future competition is compliance participation, technical competition and strength endorsement. In addition, with the end of the pilot policy and the introduction of the Notice, the future competition in the Chinese medicine formula granule market will be more intense and the existing pattern is expected to be broken.