Shandong: The rules for the management of traditional Chinese medicine formula granules set a five-year validity period

Recently, the Shandong Provincial Drug Administration, the Provincial Health Commission, and the Provincial Medical Security Bureau jointly issued the "Shandong Province Traditional Chinese Medicine Formula Granule Management Rules" (hereinafter referred to as the "Management Rules")
.
The "Administrative Rules" will come into effect on November 1, 2021, and will be valid until October 31, 2026
.
The "Administrative Rules" clarified that the traditional Chinese medicine formula granules produced, sold and used in Shandong Province should meet the national drug standards or the provincial standard of Chinese medicine formula granules
.
Manufacturers of traditional Chinese medicine formula granules are required to establish a quality traceability system and a pharmacovigilance system, and perform the main responsibility and related obligations of full life cycle management
.
At the same time, it must have a complete production capacity of traditional Chinese medicine processing, water extraction, separation, concentration, drying, granulation, etc.
, and produce in accordance with the recorded production process, and comply with national or provincial standards
.
The "Administrative Rules" stipulate that the types of Chinese medicine formula granules shall be subject to record management, and the manufacturer of Chinese medicine formula granules shall be responsible for the authenticity, completeness and traceability of the submitted record materials
.
The record information shall not be changed at will, and the record shall be updated in accordance with the procedural requirements if any change occurs
.
It is emphasized that pharmaceutical business enterprises shall not operate Chinese medicine formula granules, and Chinese medicine formula granules shall not be sold outside medical institutions
.
In addition, the "Administrative Rules" also require the strengthening of in-process and ex-post supervision of TCM formula granules, clarifying the supervisory responsibilities and requirements of the regulatory authorities for the production, distribution, and use of TCM formula granules, as well as the sampling, disposal, and recall of TCM formula granules after they are marketed.
And other relevant regulations
.
It is clarified that the drug regulatory department directly cancels the record in six situations such as providing false information or adopting other deceptive methods during the record; the drug regulatory department, the health (Chinese medicine management) department, and the medical insurance department establish a safe credit communication mechanism to deal with bad credit records.
, Increase the frequency of supervision and inspection, and implement joint punishments in accordance with regulations
.
(Qi Guirong)