Standardize the management of the labeling of traditional Chinese medicine decoction pieces, and the new regulations will be implemented

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China Research Network

The Regulations on the Labeling of Chinese Medicine Decoction Pieces issued by the State Food and Drug Administration is an important milestone in the Chinese medicine industry, aiming to standardize the market circulation of Chinese medicine decoction pieces, improve the quality management of Chinese medicine decoction pieces, and ensure the safety of consumers. The following is an analysis of the key points of the Provisions:

Scope of application and subject of responsibility

Scope of application: It is clarified that all Chinese medicine pieces produced and traded in the territory of the People's Republic of China must comply with these regulations, which means that all Chinese medicine pieces circulating in the market will be subject to strict label management.

Responsible entities: Although the Provisions do not directly list all responsible entities, generally speaking, manufacturers, operating enterprises (including wholesalers and retailers) and importers are the main responsible parties for ensuring the compliance of the labeling of TCM decoction pieces.

General requirements vs. packaging requirements

General requirements: The label should be true, accurate, scientific and legal, and should not mislead consumers. This requires that the information on the label must be based on scientific research and experimental data, and must not be exaggerated or misclaimed.

Packaging requirements: The packaging of TCM decoction pieces should be able to protect the quality and stability of the decoction pieces and prevent contamination and deterioration. Packaging materials and methods should comply with relevant regulations and standards.

Label content and printing requirements

Label content requirements: The label must contain basic content such as product name, specification, production date, and manufacturer information. In particular, from August 1, 2025, TCM decoction pieces will also need to be marked with an expiration date, which is crucial for consumers to judge the freshness and effectiveness of medicines.

Label printing requirements: The label should be printed clearly and easily legible, and should not be altered or defaced. This requires manufacturers to use high-quality printing technology and materials when printing labels to ensure the integrity and accuracy of label information.

Package label management during shipment

In the process of shipping Chinese medicine decoction pieces, the management of packaging and labeling is equally important. This requires manufacturers, operators and logistics companies to keep packaging and labels intact during transportation, storage and distribution, and prevent the loss or damage of label information caused by human or natural factors.

Identification of special Chinese medicine decoction pieces

For some Chinese medicine decoction pieces with special properties or uses, such as toxic Chinese medicine decoction pieces, endangered wild animal and plant medicinal materials Chinese medicine decoction pieces, etc., the Provisions may require additional labels or warning words to remind users to pay attention to drug safety or comply with relevant laws and regulations.

Traditional Chinese medicine decoction pieces prepared by pharmaceutical manufacturers themselves

The "Provisions" clearly point out that if the traditional Chinese medicine decoction pieces prepared by the drug manufacturer are directly used in the production of drugs, these provisions do not apply. This is mainly due to the fact that these decoction pieces as raw materials will have stricter quality control and labeling management requirements in the drug production process, so they can follow more professional drug production management regulations.

In short, the promulgation of the "Regulations on the Management of the Labeling of Traditional Chinese Medicine Decoction Pieces" will effectively promote the standardized development of the Chinese medicine decoction pieces industry and improve the quality level and market competitiveness of Chinese medicine decoction pieces. At the same time, this also requires Chinese medicine decoction pieces manufacturers and operating enterprises to strengthen internal management, ensure the authenticity and accuracy of label information, and provide consumers with safe and effective Chinese medicine decoction pieces products.

According to the data from the research report of the China Research Institute of Puhua Industry:

As an important part of the traditional Chinese medicine industry, the traditional Chinese medicine decoction piece industry has achieved remarkable development in recent years driven by many factors such as market demand, policy support and technological innovation.

First, the development status of the Chinese medicine decoction piece industry

The market size continues to grow

Expansion of market size: According to the data released by the China Research Institute of Puhua Industry, the market size of traditional Chinese medicine decoction pieces has increased from 31.5 billion yuan in 2016 to 36.8 billion yuan in 2022, with an average annual growth rate remaining stable. It is estimated that by 2024, the market size is expected to further grow to 276.4 billion yuan, showing huge development potential and growth space.

Increased demand: With the improvement of people's health awareness, the aging of the population and the increase in the number of patients with chronic diseases, traditional Chinese medicine decoction pieces are favored because of their natural, green and safe characteristics, and the market demand continues to grow.

Policy support has been strengthened

The state attaches great importance to the development of traditional Chinese medicine, and has provided a good policy environment for the development of the traditional Chinese medicine decoction piece industry through the introduction of a series of supporting policies, such as the "Outline of the Strategic Plan for the Development of Traditional Chinese Medicine (2016-2030)" and the "Healthy China 2030" Planning Outline.

The policy also includes financial subsidies, tax incentives, industrial funds, etc., which further promote the prosperity of the Chinese medicine decoction piece market.

The industrial chain is gradually improving

The Chinese herbal medicine decoction piece industry has formed a complete industrial chain including the planting, processing, and sales of Chinese herbal medicines. The cultivation and collection of upstream Chinese herbal medicines is the basis of the production of TCM decoction pieces, and its quality and supply stability have a direct impact on the quality and market supply of TCM decoction pieces.

The midstream Chinese medicine decoction processing enterprises are the backbone of the industrial chain, responsible for processing Chinese herbal medicines into Chinese medicine decoction pieces that meet the standards. The downstream includes many application fields such as clinical Chinese medicine, Chinese patent medicine production, and health care product manufacturing.

Technological innovation is constantly improving

The traditional Chinese medicine decoction piece industry has continuously innovated in the preparation process, extraction technology, preparation technology, etc., which has improved the quality and efficacy of traditional Chinese medicine decoction pieces. For example, the emergence of new Chinese medicine decoction pieces such as traditional Chinese medicine formula granules and traditional Chinese medicine broken wall decoction pieces has injected new vitality into the traditional Chinese medicine decoction piece industry.

Second, the future market economy development trend

The market size continues to expand

With the deepening of people's understanding of traditional Chinese medicine and the improvement of health demand, the market for traditional Chinese medicine decoction pieces is expected to continue to maintain steady growth. It is expected that in the next few years, the market scale will continue to expand, showing broad development prospects.

Technological innovation and personalized customization have become important directions

The TCM decoction piece industry will pay more attention to technological innovation and personalized customization to meet the diverse needs of consumers. Through the introduction of advanced production technology and technology, the R&D capacity and production level of traditional Chinese medicine decoction pieces have been improved, and more new products have been developed that meet market demand.

International cooperation and exchanges have been strengthened

The Chinese medicine decoction pieces industry will strengthen cooperation and exchanges with the international market, introduce international advanced production technology and management experience, and improve the quality and safety of Chinese medicine decoction pieces. At the same time, by participating in international exhibitions, academic exchanges and other activities, promote traditional Chinese medicine decoction pieces, and improve their visibility and influence in the international market.

The policy environment continues to be optimized

With the continuous increase of national support for the development of traditional Chinese medicine, the policy environment will continue to be optimized. In the future, more policies and measures will be introduced to support the development of the Chinese medicine decoction piece industry, providing a strong guarantee for the healthy development of the industry.

Driven by various factors such as market demand, policy support and technological innovation, the traditional Chinese medicine decoction piece industry has shown a good development trend. In the future, with the continuous expansion of the market scale, the in-depth development of technological innovation and personalized customization, and the strengthening of international cooperation and exchanges, the Chinese medicine decoction piece industry will usher in a broader development prospect.

In the future, with the improvement of people's health awareness and the popularization of traditional Chinese medicine culture, traditional Chinese medicine decoction pieces will be favored as a natural, green and safe pharmaceutical dosage form. Especially the middle-aged and elderly people, who pay more attention to health care and disease prevention, continue to grow in demand for TCM decoction pieces.

If you want to get more market research data and future development prospect trend analysis of the Chinese medicine decoction piece industry, you can click to view the research report of the China Research Institute of Puhua Industry

Pay attention to the headline number "China Research Institute of Puhua Research Institute", reply to "free report" by private message, you can get a free report, come and get it quickly!