Heavy! Four departments issued a paper to end the Chinese medicine formula particle pilot

February 18, the State Drug Administration, the State Administration of Traditional Chinese Medicine, the National Health And Health Commission and the State Administration of Medical Security jointly issued the "announcement on the end of the pilot work of Chinese medicine formula particles" (hereinafter referred to as the "announcement"), to end the pilot of Chinese medicine formula particles, and clear the pilot work after the end of the regulatory thinking.
in accordance with the Bulletin, Chinese medicine formulation particles shall be subject to record management, and their quality supervision shall be included in the management of Chinese medicine tablets, and its clinical use policy will be formulated separately by the relevant departments.
"Announcement" on the Chinese medicine formula particle production enterprises put forward capacity requirements, clear Chinese medicine formula particle standard implementation, cross-provincial use, medical insurance payment and other content, for the follow-up Chinese medicine formula particle management system construction began.
Fair competition to promote industrial development of Chinese medicine formula particles pilot is an important attempt on the road of innovation and development of Traditional Chinese medicine, the four departments jointly issued the "announcement", which means to end the pilot, a comprehensive summary of the pilot experience, give Chinese medicine formula particles reasonable positioning, guide the orderly development of Chinese medicine formula particles market, fair competition.
chinese medicine formula particles in China can be traced back to the 1990s.
It is learned that the State Administration of Traditional Chinese Medicine in 1993 to organize the development of Chinese medicine formula particles research, and then selected Jiangyin Tianjiang Pharmaceutical Co., Ltd. (then name) and Guangdong side pharmaceutical factory (then name) to carry out the pilot, and in 2001 asked the pilot enterprises to continue research to meet the needs of supervision and management.
same year, in order to cooperate with support for chinese medicine formula particle research and strengthen product supervision and management, the former State Drug Administration has approved six enterprises as national pilot enterprises for Chinese medicine formula particles.
, although the relevant national pilot enterprises have not increased, but in recent years, many enterprises by the provinces of Chinese medicine formula particles provincial pilot work into the field.
many years of pilot, Chinese medicine formula particles in the clinical Chinese medicine has played a certain positive role, its easy to use, flexible deployment and other characteristics are gradually recognized.
the end of the Chinese medicine formula particles pilot, enterprises are more supportive attitude.
, deputy general manager of Guangdong Pharmaceutical Co., Ltd., said fair competition can promote Chinese medicine formulation particle enterprises to strengthen technical research and innovation, and promote high-quality industrial development.
"Announcement" clearly defined the Chinese medicine formula particles regulatory thinking.
Strengthen management, standardize production, guide the healthy development of the industry, and better meet the clinical needs of Chinese medicine, the "announcement" at the opening point pointed out the goal of the management of Chinese medicine formula particles, and then clarified the definition of Chinese medicine formula particles, management methods and other content.
According to the Bulletin, Chinese medicine formula particles are single-flavored Chinese medicine drink tablets by water, separation, concentration, drying, granulation of particles, under the guidance of the theory of Chinese medicine, in accordance with the clinical prescription of Chinese medicine after deployment, for patients to rush to use.
quality supervision of Chinese medicine formula particles is included in the management of Chinese medicine tablets.
the implementation of the record management of Chinese medicine formula particle varieties, not the implementation of the approval number management, before the listing by the production enterprises reported to the provincial drug supervision and administration department for the record.
grasp the key non-degrading quality requirements" Chinese medicine formula particles should be a supplement to Chinese medicine tablets.
taking into account the sustainable use of Traditional Chinese medicine resources and to ensure the safety and effectiveness of product quality, it is not that the more production enterprises of Chinese medicine formula particles, the better, but should be in accordance with the clinical needs of reasonable layout, orderly production.
," said Zhang Qingbo, director of the Drug Inspection Research Center in Heilongjiang province.
The Bulletin "turned positive" the Chinese medicine formula particles, at the same time refined the capacity requirements for the production enterprises, and stressed that the Chinese medicine formula particles production enterprises should fulfill the relevant obligations of drug market licensing holders, strengthen risk management.
shall obtain a pharmaceutical production license, have complete production capacity and corresponding production scale, such as Chinese medicine preparation, extraction, separation, concentration, drying, granulation, self-made Chinese medicine tablets for the production of Chinese medicine formula particles, implement the whole process management of production, establish a traceability system Priority is given to the use of Traditional Chinese herbal medicine cultivation and breeding bases with sources that meet the requirements of the Quality Management Code for the Production of Traditional Chinese Medicines, and the promotion of the use of traditional Chinese medicines... The Bulletin puts forward detailed requirements for the production of Chinese medicine formula particles, and draws a standard bottom line for the enterprises that enter.
In Wei Mei's view, Chinese medicine formula particles is the exploration of the innovation and development of Traditional Chinese medicine heritage, the strict requirements of Chinese medicine formula particles production enterprises, is to strengthen product quality supervision needs, but also the pressure and motivation of self-regulation of enterprises.
strict drug standards are the industry's high-quality development of "knocking brick" and "paving stone", this time, the "announcement" put forward the Standard content of Chinese medicine formula particles.
the Bulletin, Chinese medicine formula particles shall be produced in accordance with the recorded production process and in accordance with national drug standards.
not stipulated in the national drug standards, they shall comply with the standards set by the provincial drug supervision and administration departments.
chinese medicine formula particles that do not have the relevant standards may not be marketed for sale.
standards formulated by the provincial drug supervision and administration departments shall comply with the provisions of the Technical Requirements for The Quality Control and Standard-Setting of Chinese Medicine Formula Particles.
the National Pharmacopoeia Commission to determine the national drug standards for Chinese medicine formulation particles, published in batches.
the promulgation and implementation of the national drug standards, the corresponding standards formulated by the provincial drug supervision and administration departments shall be abolished.
According to Song Zonghua, Deputy Director of the Operational Integrated Branch of the State Pharmacopeia Commission, the Technical Requirements for The Quality Control and Standard-Setting of Chinese Medicine Formulas regulate the standard research process in terms of basic requirements, raw materials, standard soups, production processes, standard-setting, stability and standard review, with the aim of achieving good quality control.
The National Pharmacopoeia Commission has also reformed the standard-forming mechanism to encourage enterprises to participate in the revision of the national standard system. she added:
In the past, the National Pharmacopeia Commission has published 160 Chinese medicine formula particle standards, a number of enterprises have provided relevant varieties of the draft standards and research materials, its standard research level has been improved in practice."
" strengthened management One of the keys to the effectiveness of the regulation of the use of Chinese medicine formula particles is whether there are strict requirements for the access of production enterprises and whether there is a strong inspection and follow-up after the incident.
after the reform of the drug regulatory system, the supervision responsibility of the production sector fell to the provincial drug supervision and administration departments.
The Proclamation clearly states that provincial drug supervision and administration departments should consolidate their local supervision responsibilities, undertake the record-keeping of Chinese medicine formulation particles in administrative areas, strengthen after-the-fact management, strengthen inspection, sampling and monitoring, carry out extended inspections on standardized cultivation and breeding bases of Chinese herbal medicines, and deal with illegal and illegal activities.
In addition, the provincial drug regulatory departments shall, in conjunction with the provincial Chinese medicine administrative departments, formulate corresponding management rules in conjunction with industrial policy provisions and clinical actual needs to ensure the smooth and orderly development and rational use of Chinese medicine formulation particles in their jurisdiction.
" strengthening of territory management is not a weakening of the management of Chinese medicine formula particles, but a strengthening.
Hainan, deputy director of the Drug Registration And Administration Department of the State Drug Administration, stressed.
the industry's attention to the cross-provincial sales and use of Chinese medicine formula particles, health insurance payments, etc. , the Bulletin also has provisions.
For example, where Chinese medicine formula particles are sold and used across provinces, the production enterprise shall report them to the provincial drug regulatory department at the place of use for the record, and the chinese medicine formula particles used across provinces without national drug standards shall comply with the standards formulated by the provincial drug regulatory department at the place of use.
Chinese medicine formula particles are limited to sales in medical institutions, they shall be purchased through the provincial drug centralized procurement platform sunshine procurement, online transactions, and direct distribution by the production enterprises or entrusted with storage and transportation conditions of the pharmaceutical operating enterprises distribution.
medical institutions shall sign quality assurance agreements with the production enterprises.
If the varieties of Chinese medicine tablets have been included in the scope of medical insurance payment, the provincial medical insurance departments may consider a variety of factors, after expert evaluation, the chinese medicine formula particles corresponding to Chinese medicine tablets will be included in the payment scope, and with reference to Class B management.
with the end of the pilot work, the development of Chinese medicine formula particle industry opened a new chapter.
the healthy development of Chinese medicine formula particle industry needs multi-sectoral cooperation, scientific research and operation, need the joint efforts of the whole industry.
all parties expressed their expectations for the orderly and healthy development of the Chinese medicine formula particle industry.
State Administration of Traditional Chinese Medicine, State Administration of Traditional Chinese Medicine, National Health And Health Administration of the National Health Insurance Bureau on the end of the pilot work of Chinese medicine formula particles (No. 22 of 2021) in order to strengthen the management of Chinese medicine formula particles, standardize the production of Chinese medicine formula particles, guide the healthy development of the industry, better meet the clinical needs of Chinese medicine, after research decided to end the pilot work of Chinese medicine formula particles.
The relevant matters will now be announced as follows: First, Chinese medicine formula particles are single-flavored Chinese medicine tablets by water, separation, concentration, drying, granulation of particles, under the guidance of the theory of Chinese medicine, in accordance with the clinical prescription of Chinese medicine after deployment, for patients to rush to use.
quality supervision of Chinese medicine formula particles is included in the management of Chinese medicine tablets.
, the Chinese medicine formula particle varieties to implement the record management, not to implement the approval number management, before the listing by the production enterprises reported to the provincial drug supervision and administration department for the record.
, the production of Chinese medicine formula particles should obtain a "drug production license", and at the same time have Chinese medicine tablets and particulate production range.
production enterprises of Chinese medicine formulation particles shall have complete production capacity of Chinese medicine concocing, extracting, separating, concentrating, drying, granulation, etc., and have the corresponding production scale with the quantity of varieties produced and sold.
shall make their own Chinese medicine tablets for the production of Chinese medicine formula particles.
. The production enterprises of Chinese medicine formulation particles shall fulfill the main responsibilities and related obligations of the whole life cycle of the drug, implement the management of the whole process of production, establish a traceability system, gradually realize the source of traceability, go to catch-up, and strengthen risk management.
the production process of Chinese medicine formula particles such as Chinese medicine tablet preparation, water, separation, concentration, drying and granulation shall comply with the relevant requirements of the Quality Management Standard (GMP) for pharmaceutical production.
chinese herbal medicine required for the production of Chinese herbal medicine formula particles, which can be planted and farmed by hand, priority shall be given to the use of Chinese herbal medicine from the chinese herbal medicine cultivation and breeding base that meets the requirements of the quality management standards for the production of Chinese herbal medicine.
promote the use of authentic herbs.
5. The provincial drug supervision and administration departments, together with the provincial Chinese medicine authorities, shall formulate corresponding management rules in the light of the relevant provisions of the national and local industrial policies and the actual clinical needs, adhere to the main position of Chinese medicine tablets, and ensure the smooth and orderly development and rational use of Chinese medicine formula particles within the jurisdiction.
provincial drug supervision and administration departments shall consolidate their local supervision responsibilities.
to undertake the filing of Chinese medicine formula particles in the administrative area.
strengthen after-the-fact management, strengthen inspection, sampling and monitoring, carry out extended inspection of standardized cultivation and breeding bases for Chinese herbal medicines, and deal with illegal and illegal activities.
, Chinese medicine formula particles shall be produced in accordance with the recorded production process, and in line with national drug standards.
not stipulated in the national drug standards, they shall comply with the standards set by the provincial drug supervision and administration departments.
provincial drug supervision and administration department shall, within 30 days after the publication of the standards it has formulated, report the supporting documents, standard texts and preparation notes of the standards to the State Pharmacopoeia Commission for the record.
chinese medicine formulation particles that do not have national drug standards or standards formulated by provincial drug supervision and administration departments shall not be listed for sale.
, the National Pharmacopoeia Commission in conjunction with the pilot work experience to organize the review of Chinese medicine formula particles of the national drug standards, published in batches.
standards formulated by the provincial drug supervision and administration departments shall comply with the provisions of the Technical Requirements for The Quality Control and Standard-Setting of Chinese Medicine Formula Particles.
the promulgation and implementation of the national drug standards for chinese medicine formulation particles, the corresponding standards formulated by the provincial drug regulatory department shall be abolished immediately.
the sale and use of Chinese medicine formula particles across provinces, the production enterprise shall report them to the provincial drug supervision and administration department at the place of use for the record.
chinese medicine formulation particles that do not have national drug standards are used across provinces, they shall meet the standards established by the provincial drug supervision and administration department at the place of use.
, Chinese medicine formula particles may not be sold outside medical institutions.
chinese medicine formulation particles used by medical institutions shall be purchased and traded online through the provincial drug centralized procurement platform.
shall be distributed directly by the production enterprise, or by the pharmaceutical operating enterprise with storage and transportation conditions entrusted by the production enterprise.
enterprises that accept the distribution of Chinese medicine formula particles shall not entrust distribution.
medical institutions shall sign quality assurance agreements with the production enterprises.
10, Chinese medicine drinking tablet varieties have been included in the scope of medical insurance payment, the provincial health insurance departments can take into account clinical needs, fund payment capacity and price and other factors, after expert review will be the corresponding Chinese medicine formula particles into the payment scope, and refer to Category B management.
11. The chinese medicine formula particle conditioning equipment shall conform to the clinical drug habits of Chinese medicine, shall effectively prevent errors, pollution and cross-contamination, and the materials that come into direct contact with the chinese medicine formula particles shall conform to the medicinal requirements.
the transfer software used by the company should be traceable to the transfer process.
12, direct contact with Chinese medicine formula particle packaging label should at least be marked with the record number, name, Chinese medicine drink tablets implementation standards, Chinese medicine formula particles implementation standards, specifications, production date, product lot number, shelf life, storage, production enterprises, production address, contact information and other content.
13th, this announcement will come into effect on November 1, 2021.
the implementation of this announcement, the Notice on the Issue of the Interim Regulations on the Administration of Particles of Chinese Medicine Formulas (No. 325 of the State Drug Administration Note (2001)) shall be repealed.
chinese medicine formulation particles in clinical use policy, by the relevant departments to study a separate formulation or clear.
this announcement.
State Administration of Medicine, State Administration of Traditional Chinese Medicine, National Health And Health Administration, February 1, 2021