On October 11, the Shandong Provincial Food and Drug Administration issued the Announcement on the Implementation of Shandong Provincial Standards for Traditional Chinese Medicine Formula Granules (First Batch), announcing a total of 80 provincial standards for the first batch of Chinese medicine formula granules. The batch of standards will be officially implemented from November 1, 2021.
On the basis of fully investigating and understanding the needs of enterprises, the Shandong Provincial Food and Drug Administration has formulated relevant procedures in accordance with relevant national regulations and national drug standards, and since April this year, it has organized the review of 11 batches of 165 Chinese medicine formula granule standards, and announced and solicited opinions from the public. On the basis of absorbing relevant opinions, the Shandong Provincial Food and Drug Administration issued provincial standards for 80 traditional Chinese medicine formula granules such as rhubarb and peach kernel.
On February 10, the State Food and Drug Administration and other four departments jointly issued the "Announcement on Ending the Pilot Work of Traditional Chinese Medicine Formula Granules" (hereinafter referred to as the "Announcement on ending the Pilot"), which will be implemented from November 1, 2021. The "Announcement on the End of the Pilot" requires that the formula granules of traditional Chinese medicines should meet the national drug standards, and if there is no national drug standard, it should meet the standards formulated by the provincial drug supervision and management departments. Therefore, the introduction of provincial standards can be described as a tight time and heavy tasks.
"At present, the standards for 80 varieties have been officially released, and a second batch will be released in the near future, and it is expected that there will be nearly 200 provincial standards before the end of the year." Coupled with the nearly 200 national standards currently issued and announced by the state, at that time, the standard system for traditional Chinese medicine formula granules in Shandong Province will be initially completed, which can basically meet the standard needs of the production and clinical use of traditional Chinese medicine formula granules in our province. Cao Sen, director of the registrar of the Shandong Provincial Food and Drug Administration, introduced. The Shandong Provincial Food and Drug Administration completed such a number of standard review work in a short period of time, thanks to the "early planning" of the bureau's research on traditional Chinese medicine formula granules. In 2019, Shandong Province began to carry out pilot research on chinese medicine formula granules. "At that time, we realized that Chinese medicine formula granules would face gradually rising from enterprise standards to provincial standards and national standards, so we began early planning." Cao Sen said that since 2019, the Shandong Provincial Food and Drug Administration has spent more than 3 million yuan in special funds every year, concentrated the drug inspection and research resources of the whole system, obtained support in terms of human, material and financial resources, and fully carried out the research of provincial Chinese medicine formula granule standards.
Establishing a sound standard system is an important basis for standardizing the development of Chinese medicine formula granules. Since the pilot work was carried out, the Shandong Provincial Food and Drug Administration has referred to the requirements and procedures for the formulation of national standards, and studied the formulation of provincial standards with the positioning of "high standards". After the release of the "Announcement on the End of the Pilot", the Shandong Provincial Food and Drug Administration set up a special working group at the first time, combined with the actual situation of Shandong Province, established and implemented the working mechanism of "enterprise declaration, review by inspection agencies, expert review, hanging network publicity, verification feedback, revision and release", and carried out standard review in strict accordance with the "Technical Requirements for Quality Control and Standard Formulation of Chinese Medicine Formula Granules" to achieve standardized process.
Meeting the needs of the market and enterprises is an important principle of Shandong Province to formulate provincial standards for traditional Chinese medicine formula granules. On the basis of the survey, the Shandong Provincial Food and Drug Administration gives priority to the selection of varieties that are urgently needed by the market, have a large supply and meet the compatibility needs of clinical groups to formulate provincial standards. After the end of the pilot to the end of December, the Shandong Provincial Food and Drug Administration will maintain the normalization of standard formulation, hold expert review meetings on a regular basis, and review and approve new submitted materials, supplementary materials and feedback, so as to ensure that the standard preparation work is uninterrupted and gradually meets the market demand. In addition, the Shandong Provincial Food and Drug Administration also fully considers the actual situation of enterprises, and regards the production verification of standards by enterprises as an important part of the formulation of provincial standards to ensure that provincial standards meet the production needs of enterprises. At the same time, the Shandong Provincial Food and Drug Administration took the lead in the country to issue the quality management guidelines for the production of Traditional Chinese medicine formula granules - "Shandong Province Traditional Chinese Medicine Formula Granules Production Quality Management Guidelines (Trial)", urging enterprises to establish a quality management system that meets the characteristics of Traditional Chinese medicine formula granules.
It is reported that the implementation rules for traditional Chinese medicine formula granules in Shandong Province will be issued and implemented in the near future to effectively strengthen the management of traditional Chinese medicine formula granules. (Qi Guirong)
