On March 17, the State Food and Drug Administration, the Ministry of Agriculture and Rural Affairs, the State Forestry and Grassland Administration, and the State Administration of Traditional Chinese Medicine jointly issued an announcement on the "Good Manufacturing Practice for Chinese Medicinal Materials", which was implemented from the date of publication.
It is understood that the previous version of the Chinese herbal medicine GAP was the "Good Manufacturing Practice for Chinese Herbal Medicines (Trial)" that came into effect on June 1, 2002; in 2012, the relevant departments began to promote the revision of the Chinese herbal medicine GAP, just 10 years from the release of the latest version of the Chinese herbal medicine GAP.
According to the content of the announcement, the new version of Chinese herbal medicine GAP is formulated in accordance with the Drug Administration Law of the People's Republic of China and the Law of the People's Republic of China on Traditional Chinese Medicine in accordance with the Opinions of the CPC Central Committee and the State Council on Promoting the Inheritance and Innovative Development of Traditional Chinese Medicine, promoting the standardized production of Chinese herbal medicines, strengthening the quality control of Chinese herbal medicines, and promoting the high-quality development of Chinese medicines.
This specification applies to the whole process management of the standardized production of Chinese herbal medicines by Chinese herbal medicine production enterprises, and is the basic requirement for the standardized production and management of Chinese herbal medicines. The Chinese medicinal materials involved in this specification refer to the medicinal raw materials used in the production of traditional Chinese medicine tablets and traditional Chinese medicine preparations after standardized planting (including ecological planting, wild care and imitation wild cultivation), breeding, harvesting and processing in the place of origin, derived from medicinal plants, medicinal animals and other resources.
The reporter combed and found that the new version of the Chinese herbal medicine GAP has a total of 14 chapters and 144 articles, which has made detailed provisions on the quality management of Chinese herbal medicines, base site selection, planting and breeding, harvesting and processing of production areas, packaging, release and storage and transportation, quality inspection and other aspects.
It is worth noting that Articles 8 and 9 of the new version of the Good Manufacturing Practice for Chinese Herbal Medicines require that enterprises should clarify the production batches of Chinese herbal medicines to ensure the consistency and traceability of the quality of each batch of Chinese herbal medicines. Enterprises shall establish a traceability system for the production quality of Chinese herbal medicines to ensure that the key links in the whole process from production plots, seeds and seedlings or other propagating materials, planting and breeding, harvesting and processing, packaging, storage and transportation to the place of origin can be traced; encourage enterprises to use modern information technology to build a traceability system.
Some insiders pointed out that it is expected that while the new version of GAP is fully reshuffling the production pattern of Chinese herbal medicines, it will also force Chinese medicine tablets and Chinese medicine preparation enterprises to carry out a new upgrade - whether it is full traceability, or self-built origin, the use of medicinal materials that meet the requirements of the new version of GAP, which puts forward higher requirements for Chinese medicine enterprises.
