End of the pilot, innovation and start again
End of the pilot, innovation and start again
Medical Network News on August 23 As soon as the pilot work of traditional Chinese medicine formula granules ended, a new wave of innovation surged across the face.
According to data from the Public Opinion Monitoring Center of China Health Media Group: On February 10 this year, the State Food and Drug Administration and the State Administration of Traditional Chinese Medicine jointly issued the "Announcement on Ending the Pilot Work of Chinese Medicine Formula Granules" (hereinafter referred to as the "Announcement") , Decided to end the pilot work of traditional Chinese medicine formula granules, and clarified the supervision matters after the pilot work. After the announcement of the "Announcement", various provincial drug regulatory authorities have successively issued the work procedures for formulating the quality standards of traditional Chinese medicine formula granules and the requirements for application materials, and issued detailed implementation rules in many places to actively implement the requirements of the "Announcement" and accelerate the implementation of the policy of traditional Chinese medicine formula granules.
Supporting policies have been introduced one after another
The "Announcement" clarified that from November 1st, the quality supervision of TCM formula granules will be included in the management of TCM decoction pieces, and the varieties of TCM formula granules will be subject to record management. This means that the provincial drug regulatory authorities will play an important role in the supervision of traditional Chinese medicine formula granules.
On February 20, the Guangdong Provincial Food and Drug Administration issued the "Technical Requirements for Quality Control and Standard-setting of Guangdong Traditional Chinese Medicine Formula Granules (Trial)" and "Guangdong Province Traditional Chinese Medicine Formula Granules Standard Supplementary Working Procedures and Application Data Requirements (Trial)". Subsequently, Yunnan, Shaanxi, Hainan, Guizhou and other provinces (autonomous regions, municipalities) drug regulatory departments have successively released the working procedures for formulating the quality standards of traditional Chinese medicine formula granules and the requirements for application materials, and actively implemented the relevant requirements of the "Announcement".
Shaanxi is the first province in the country to issue detailed regulations for the management of Chinese medicine formula granules. On July 1, the five departments including the Shaanxi Provincial Food and Drug Administration and the Provincial Traditional Chinese Medicine Administration jointly issued the "Shaanxi Provincial TCM Formula Granule Management Regulations (Trial)" (hereinafter referred to as the "Shaanxi Provincial Management Regulations").
"We gave full play to our advantages as the lead unit of the Shaanxi Provincial Leading Group for Deepening the Reform of the Review and Approval System, actively contacted relevant departments and bureaus, and took the lead in drafting the "Management Rules of Shaanxi Province", which was formally printed and issued after soliciting opinions, becoming the first in the country. Provinces with detailed regulations on the management of traditional Chinese medicine formula granules.” said Qu Jianpeng, director of the Drug Registration Management Office of the Shaanxi Provincial Drug Administration.
On July 27, the Hainan Provincial Food and Drug Administration and the Provincial Administration of Traditional Chinese Medicine jointly issued the "Implementation Rules for the Management of Hainan Traditional Chinese Medicine Formula Granules (Trial)" (hereinafter referred to as the "Implementation Rules of Hainan Province"), which is a successor to Shaanxi Province. Later, another province issued the implementation rules for the management of traditional Chinese medicine prescription granules. "Although there are no manufacturers of traditional Chinese medicine formula granules in our province, the implementation rules will be released as soon as possible, which will help attract relevant companies to deploy in Hainan." said Wang Gang, director of the Drug Registration and Production Supervision Division of the Hainan Provincial Drug Administration.
On August 12, the Shandong Provincial Food and Drug Administration issued the "Shandong Province Traditional Chinese Medicine Formula Granule Production Quality Management Guidelines (Trial)", which put forward quality management requirements for the institutions and personnel of the manufacturing enterprises, plants, facilities, and equipment.
All relevant parties accelerate progress
The standard of traditional Chinese medicine formula granules has always been the focus of the industry, and the construction of relevant national standards is accelerating. On April 29, the State Food and Drug Administration approved and promulgated the first batch of national drug standards (160) for Chinese medicine formula granules. In addition, there are 39 Chinese medicine formula granules national drug standards are under review, and another 246 Chinese medicine formula granules have enterprises that are conducting standard research.
Various provincial drug regulatory authorities are also stepping up the formulation and release of relevant standards for Chinese medicine formula granules. On March 9, Shaanxi Provincial Food and Drug Administration issued the "Shaanxi Provincial Standards for Traditional Chinese Medicine Formula Granules" (Volumes 1 and 2). "These two volumes of standards contain the standards for traditional Chinese medicine formulation granules for authentic medicinal materials, bulk medicinal materials and clinically more commonly used species in Shaanxi Province." Qu Jianpeng said that in accordance with the requirements of the State Food and Drug Administration, Shaanxi Food and Drug Administration has initiated 322 varieties of medicines. Revision and improvement of the standard of Chinese medicine formula granules. Up to now, the research data of 226 types of traditional Chinese medicine formula granules have been collected, and the compilation is under way. It is planned to officially announce and implement Shaanxi Province TCM formula granule standards for about 300 types in October.
Gansu, Zhejiang, Guizhou and other provinces (autonomous regions, municipalities) drug regulatory bureaus have successively issued standards for traditional Chinese medicine formulation granules in their provinces, laying a solid foundation for improving the overall quality control of traditional Chinese medicine.
“The Hainan Provincial Food and Drug Administration will release the quality standards for the first batch of TCM formula granules in Hainan Province before the end of October. After the standard is released, varieties that do not have the national drug standards for TCM formula granules or the Hainan Province standard will not enter the clinical use link in Hainan Province. "Wang Gang said.
In the context of policy "relaxation" and unrelaxed supervision, speeding up the research on the standard of traditional Chinese medicine formula granules has also been listed as a key task by various enterprises. Wei Mei, deputy general manager of Guangdong Yifang Pharmaceutical Co., Ltd., said that the company’s most important job is to organize production in accordance with the announced national standards and actively promote the formulation of provincial standards. "In order to ensure the quantity and quality of provincial standards, our company formed an alliance with 5 other former national Chinese medicine formula granule pilot production enterprises to carry out cooperative research on all types of formula granules currently on the market, and quickly advance the formulation of provincial standards." Wei Mei said.
Zhang Zhiqiang, R&D director of Beijing Kangrentang Pharmaceutical Co., Ltd., also believes that the most important job at present is to actively participate in the declaration of national standards and provincial standard systems to ensure that products meet national standards and actively promote the inclusion of provincial standard systems.
Standard formulation is also extending upstream. "In the next step, the Shaanxi Provincial Food and Drug Administration will carry out the construction of a standard system for Chinese medicinal materials (including fresh-cut Chinese medicinal materials) and Chinese medicinal pieces, and gradually establish and improve a quality management system for the entire chain of authentic medicinal materials to ensure the safety and effectiveness of Chinese medicine formula granules. "Qu Jianpeng said.
Future market pattern to be determined
Based on the influence of Chinese medicinal materials on the quality of Chinese medicinal formula granules, Zhang Zhiqiang introduced that Tianjin Hongri Pharmaceutical Co., Ltd. (hereinafter referred to as Hongri Pharmaceutical), a subsidiary of Kangrentang, makes full use of the characteristic resources of medicinal materials from various places, and has established sales in Hubei, Gansu, Sichuan and other places. Establish an automated production base for Chinese medicine formula granules in a regional layout with rich medicinal resources. On June 7, Hongri Pharmaceutical announced that it would invest 750 million yuan to build an intelligent manufacturing base of traditional Chinese medicine formula granules in Shandong. This is the eighth production base of Hongri Pharmaceutical in the industrial layout of traditional Chinese medicine granules.
In addition to Hongri Pharmaceutical, some pharmaceutical companies are also accelerating their deployment in the traditional Chinese medicine formula granule industry. On May 10th, Shanxi Guoxin Tianjiang Pharmaceutical Co., Ltd. started trial production of the Chinese medicine decoction pieces and formula granule workshop; on June 25th, Yunnan Shenwei Spree Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Shenwei Pharmaceutical Group, built the " "Yunnan Provincial Key Laboratory of Traditional Chinese Medicine Prescription Granules" "Yunnan Province Traditional Chinese Medicine Prescription Granule Engineering Research Center" was inaugurated.
The drug data query system of the State Food and Drug Administration shows that there are currently 34 drug manufacturing companies whose production scope covers traditional Chinese medicine formula granules, including listed companies such as Guangzhou Xiangxue Pharmaceutical Co., Ltd. and Harbin Zhenbaodao Pharmaceutical Co., Ltd..
It is not difficult to see that the competition in the Chinese medicine formula granule market will become more intense in the future. However, the end of the pilot work of traditional Chinese medicine formula granules does not mean that management is relaxed.
The "Announcement" refines the capacity requirements for Chinese medicine formula granule manufacturers, and emphasizes that they should perform the main responsibility and related obligations of the drug throughout the life cycle, and strengthen risk management. The "Management Rules of Shaanxi Province" puts forward specific requirements on the basic conditions, research and production management, and filing materials of Chinese medicine formula granules production enterprises. The “Implementation Rules of Hainan Province” also stipulates that medical institutions are the only sales channel for TCM formula granules. It is clear that TCM formula granules used in public hospitals should be purchased through the Hainan Province’s centralized drug procurement platform and trade online. Recorded varieties of Provincial Drug Administration, etc.
"In the next step, the Shaanxi Provincial Food and Drug Administration will focus on the establishment of a traceability system for the entire industry chain to strengthen the main responsibility of enterprises; strengthen supervision during and after the event, and gradually improve the safety and effectiveness evaluation system of traditional Chinese medicine formula particles after the market; actively cooperate with relevant departments Establish a multi-departmental linkage and coordination management mechanism to coordinate and support industrial development." Qu Jianpeng said.
Wang Gang introduced that the Hainan Provincial Food and Drug Administration plans to include traditional Chinese medicine formula granule production enterprises in routine inspections, and conduct special inspections when necessary, and implement extended inspections on the enterprise's standardized planting and breeding bases of Chinese medicinal materials to ensure the quality of formula granules from the source.
Wei Mei said that in the context of increasing barriers to entry in the traditional Chinese medicine formula granule industry, and the gradual tightening of technical specifications and supervision, there should not be many new companies entering the Chinese medicine formula granule market. Zhang Zhiqiang believes that the implementation rules are only one of the supporting documents related to Chinese medicine formula granules issued in various places, and enterprises are still waiting for the introduction and implementation of other supporting documents.
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