Attachment2

Explanation of the Drafting Principles for "Technical Guidelines on Assessment of Traditional Chinese Medicine Resources"

I. Background

"Measures for the Administration of Drug Registration" and "Supplementary Provisions on the Administration of Traditional Chinese Medicine Registration" (National Medical Products Administration)Note〔2008〕3as stipulated in the No.“Ensure stable sourcing of Chinese herbal medicines and sustainable resource utilization”。2014In recent years, the National Medical Products Administration approved "Research on Resource Assessment and Countermeasures in TCM Registration" as a policy research project, entrusting the Chinese Academy of Traditional Chinese Medicine's Center for TCM Resources to conduct the study. The primary objective is to draft the "Technical Guidelines for TCM Resource Assessment" (hereinafter referred to as the "Guidelines").

After receiving the task, the research group organized units from the China Food and Drug Administration, the State Administration of Traditional Chinese Medicine, the China Academy of Chinese Medical Sciences, the Chinese Academy of Medical Sciences, the National Institutes for Food and Drug Control, Peking University, Tianjin University, and others.20A group of experts discussed and developed the research plan. The project team advanced according to schedule, held multiple consultation meetings with the China Food and Drug Administration, the National Administration of Traditional Chinese Medicine, and relevant enterprises, and produced a draft of the "Guiding Principles."2015Year12Month29The National Medical Products Administration (NMPA) convened a project completion meeting, at which experts unanimously agreed to the project's conclusion. Subsequently, the NMPA's Division of Drug and Cosmetic Registration Management(hereinafter referred to as the Division of Drug and Chemical Registration of the General Administration)Conducted multiple research sessions and discussions with the project team and relevant experts.and seek the opinion of the Drug Evaluation Center of the National Medical Products Administration (hereinafter referred to as the CDE).The draft for the "Guiding Principles" has been finalized., at2017Year10Month11Sun—31The National Medical Products Administration of China has published a draft for public comment on its official website.2017Year11Month29The Drug Registration Division of the State Administration for Medical Products, in collaboration with the Center for Drug Evaluation and relevant experts, convened a finalization meeting. Reasonable feedback gathered during the public consultation was fully incorporated, and after reviewing the [Document Name]...GuidelinesThe draft for public comment was revised and finalized to form the issued version of the "Guiding Principles."。

II. Main Drafting Approach

The following approach was followed during drafting:

The primary objective of TCM resource assessment is to promote the sustainable utilization of TCM resources and enableMarketing Authorization Holder or ManufacturerCompanies establish“Traditional Chinese medicine (TCM) industrial production should prioritize ensuring the yield and quality of TCM resources.”philosophy。Therefore，Primary target audience for this guidelineone ofYesMarketing Authorization Holder orManufacturerThe traditional Chinese medicine resource assessment conducted is based on the resources required by the marketing authorization holder or the manufacturing enterprise to meet drug registration and regulatory requirements.Estimated Consumption and Estimated AvailabilityAssessment of the balance relationship, rather than a nationwide biological or ecological resource assessment.

Second, the scope of TCM resource assessment includes proprietary Chinese medicines and processed Chinese herbal pieces.WaitRepresentative of all traditional Chinese medicine industrial production.

Third, TCM resource assessment involves not only yield but also quality. Yield assessment ensures the availability of raw materials for enterprise production, while quality assessment ensures their stability and controllability.

FourthlyUse in TCM Industrial ProductionSourcePlanting and BreedingWe need both wild and cultivated medicinal herbs.LaunchTraditional Chinese Medicine (TCM) resource assessment also includesUseChinese herbal medicines sourced from imports.

III. Key Contents of the "Guiding Principles"

The "Guidelines" consist of five sections:

Part 1: Overview. This section outlines the legal basis for developing the Traditional Chinese Medicine (TCM) Resource Assessment Guidelines, defines the scope and objects of assessment, and clarifies the definition of TCM resource assessment.

ThePart 2: Basic Principles. TCM resource assessment work should align with“Uphold the basic national policy of conserving resources and protecting the environment.”Align with sustainable development by protecting resources and ensuring their long-term viability; balance high-quality demand with supply security; and adapt dynamically to changes in actual resource reserves and circulation.

Part III covers Traditional Chinese Medicine (TCM) resource assessment. TCM manufacturing consumes TCM resources, posing potential consumption risks. Therefore, the "Guiding Principles for TCM Resource Assessment" provides recommendations on three key aspects: estimated consumption volume, potential risks, and sustainable utilization measures.Marketing Authorization Holder or ManufacturerEnter enterprise data, independently evaluate resource availability for each ingredient in the prescription, and submit the evaluation report.

Part IV covers the decision-making and dynamic adjustment of Chinese herbal medicine resource assessment, based on the projected consumption andEstimatedAvailableQuantitymatch conditions, analyze whether sustainable utilization measures can effectively prevent potential risksmakeTCM Resource Assessment Decision

Section 5 is an attachment.IncludingFormatting Requirements for Traditional Chinese Medicine Resource Assessment Report(includingData Summary Table), plantingChinese herbal medicineReferencePlant Catalog.

IV. Key Points to Note

(I) Refer to relevant international practices.Currently, countries such as the United States and Canada have established environmental impact assessment (EIA) as a key legal framework within their environmental protection laws. This Guidance draws on relevant international experience. The United States has issued a series of guidance documents for resource approval during the new drug registration process by the U.S. Food and Drug Administration (FDA).FDA) at2004Year6Yue officially published the "Guidelines for the Development of Plant Medicines" on its website (Industry Guidance: Botanical Drug Products), requiring plant medicine development units to submit an assessment report on the impact of their development and production activities on the environment (including resources) as part of their application materials.Canada also places significant emphasis on the environmental impact of government decisions. Environmental assessment and review procedures serve as critical planning tools in the decision-making process, used to predict the environmental consequences of proposed federal government actions. Typically, an Environmental Impact Statement includes the following components:①Description of a plan;②Explain the plan's requirements and evaluate available options.③Describe the current environmental conditions, resource utilization, and social aspects.④Predict potential impacts;⑤Explain how to reduce or completely avoid adverse effects.

(II) Explanation of TCM Resource Assessment Indicators.During the discussion of the "Guidance Principles," five indicators were initially considered for evaluation: circulation volume, stock levels, projected consumption, risk characteristics, and sustainable utilization measures. Assessing circulation volume and stock levels helps manufacturers understand the current status and trends of their herbal resource usage, fostering a macro-level understanding of these resources. The projected consumption assessment enables manufacturers to estimate their own potential resource use by analyzing consumption patterns in similar products. Ensuring that the sustainable utilization measures adopted by manufacturers guarantee stable quality and continuous supply is critical to resource assessment. However, field surveys and discussions with enterprises revealed that evaluating circulation volume and stock levels presents significant challenges. Consequently, only three indicators were retained: projected consumption, risk characteristics, and sustainable utilization measures.

(III) Explanation of Fixed Origin.The "Guiding Principles" require enterprises to establish fixed production sites and advocate the use of authentic medicinal herbs. The quality of Chinese medicine is primarily influenced by genetic factors, environmental conditions, and human practices.，A fixed origin is essential for ensuring the quality of Chinese herbal medicines. Due to cultivation challenges such as continuous cropping obstacles, "fixed origin" does not require a company to remain on a single plot of land; rather, it requiresMarketing Authorization Holder or ManufacturerThe enterprise's base must be located within a specific region where medicinal plant quality exhibits minimal variation and remains relatively uniform. Wild medicinal plants also...BecauseUnder the same influencing factors, a fixed origin is required.

(IV) AboutZhenThinEndangereddescription.There are many causes of damage to Chinese herbal medicine resources, with over-harvesting leading to the decline of medicinal plant populations.、Habitat destruction，Climate change causes natural resource depletion. Internationally, it is widely adoptedIUCNYesThreatenedofSpeciesAssess endangered statusDivide. Marketing Authorization Holder or ManufacturerEnterprises can refer to various ministries and commissions.and localWild Chinese Medicinal Resources Cataloged in Published InventoriesZhenthinEndangeredcircumstances, theseNameList includes the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES）Appendix1、2，"List of National Key Protected Wild Animals," "List of National Key Protected Wild Plants (No.1[Batch)], "List of Key National Protected Wild Medicinal Plant Species", etc.and local protected lists。

(V) RegardingPlantChinese herbal medicineReferenceDirectory description.Marketing Authorization Holder or ManufacturerWhen conducting TCM resource assessments, enterprises are required to evaluate resources that can be artificiallyPlantStandardized production bases must be established for Chinese herbal resources. However, due to incomplete information held by enterprises, it is difficult to determine whether a specific herbal resource is suitable.Artificially cultivated. For convenienceMarketing Authorization Holder or ManufacturerEnterprises assess whether Chinese medicinal resources can be artificially cultivated.PlantWhen drafting the guidelines, planting experts were invited to contribute based on actual market conditions.2015YearChinese Pharmacopoeia edition listed Chinese medicinal materialsofHumanPlanting StatusFiltered and generated“PlantChinese herbal medicineReferencePlant Catalog”and include this list as an appendix to the guidelines.