Understanding Medicinal Grade Herb Standards
China has spent the past two decades building one of the world’s most comprehensive regulatory ecosystems for herbal materials. The backbone is the Pharmacopoeia of the People’s Republic of China (often shortened to the Chinese Pharmacopoeia, or ChP)—a legally enforceable compendium that sets identity, quality, purity, safety, and processing requirements for hundreds of crude drugs (Chinese materia medica) and their processed forms (decoction pieces). Alongside the ChP sit practice-based frameworks (GAP, GMP, GSP), international standards (ISO/TC 249), and regional companions like Hong Kong’s Chinese Materia Medica Standards (HKCMMS). Together, they define what “quality” means for Chinese medicinal herbs—from farm to formula.
National Medical Products Administration
Below is a practical overview of these standards—structured around who sets them, how herbs are authenticated and tested, what contamination limits apply, how processing is standardized, and what’s changing in 2025.
1) The rulebook and who writes it
The Chinese Pharmacopoeia (ChP)
The ChP is the official, state pharmacopeia. It is updated roughly every five years, with the 2025 Edition issued on March 25, 2025, and effective October 1, 2025 (replacing ChP 2020). For manufacturers and marketing authorization holders, the 2025 update triggers transition obligations and possible upgrades to registration standards where the ChP becomes stricter.
ChP monographs specify: botanical source(s), macroscopic/microscopic identification, chromatographic identification, characteristic fingerprints, marker/assay requirements, moisture/ash/extractive limits, processing notes for decoction pieces, and limits for impurities and contaminants (e.g., heavy metals, pesticide residues, mycotoxins, sulfur dioxide, microbes). Overarching General Chapters/Rules set the common analytical methods and system suitability expectations that apply across monographs.
Beyond monographs, NMPA has promulgated Good Agricultural Practice (GAP) for Chinese crude drugs (most recently refreshed and re-issued with effect from March 2022) to govern cultivation, harvest, primary processing, and site management of raw herbal materials. It is intended to control germplasm, origin, inputs, and traceability—minimizing adulteration and contamination from the start.
Other practice systems (not all detailed here) include GMP for manufacturing and GSP for distribution; when herbal materials are manufactured into decoction pieces or finished products, GMP principles apply and often link back to ChP methods and acceptance criteria.
International and regional companions
ISO/TC 249 (Traditional Chinese medicine) develops globally referenced standards that complement ChP—covering labelling (ISO 21371), heavy-metal test methods (ISO 18664), storage (ISO 22217), identity testing and microscopy, and more. These are widely used in cross-border trade and by manufacturers serving non-Chinese markets.
Hong Kong Chinese Materia Medica Standards (HKCMMS) provide monograph-style standards (source, identification, tests, assay) for individual CMMs. As of December 2024, 11 volumes covering 344 CMM had been published, and they are explicitly framed to harmonize with international standards and facilitate trade.
2) Identity: how Chinese standards make sure you have the right herb
Authentication is multi-layered. The ChP combines botanical taxonomy, macroscopic characters (shape, colour, odour, taste), microscopic diagnostics (tissues, secretory cells, trichomes, starch grains), and chemical identification (e.g., TLC/HPLC reference-substance comparisons and, increasingly, fingerprint profiles) to ensure the crude drug matches the true species and the required part (root, rhizome, bark, etc.). These techniques are codified in ChP general chapters and then tailored in each monograph.
PMC
DNA barcoding has become an influential adjunct in China’s research and, increasingly, industrial practice. The ITS2 locus (sometimes with psbA-trnH) is a widely supported barcode for verifying plant identity, especially where morphology is altered or processed. Multiple large-scale studies have validated ITS2’s discriminatory power for Chinese herbal materials, supporting procurement QA and helping detect substitutes/adulterants. While barcoding is not (yet) a universal legal requirement for every monograph, it is aligned with the direction of travel for identity assurance and appears in ISO/TC 249 work and enterprise practice.
Key takeaway: For regulatory alignment and export-grade quality systems, combine classical ChP ID (macro/micro + chemical) with risk-based DNA barcoding—especially for high-value, easily adulterated, or highly processed botanicals.
3) Quality specifications inside the ChP monographs
Typical quality specs for crude drugs and decoction pieces include:
Moisture (loss on drying) and ash (total/acid-insoluble) to control basic physical purity.
Extractives (e.g., ethanol/water-soluble) to ensure consistent extractable matter.
Marker compounds and assays. Many monographs set a minimum content for signature constituents (or a defined ratio among multiple compounds) using HPLC/GC/UPLC methods, often alongside fingerprint similarity requirements. This legitimizes the multi-component nature of TCM by evaluating both identity and chemical integrity.
PMC
Where an herb is traditionally used only after processing (e.g., vinegar-processed Radix Bupleuri), the processed form becomes the primary standard. The ChP increasingly ties the actions/dosage to the decoction piece, not the crude raw, and specifies paozhi parameters (media like wine, vinegar, ginger juice; temperatures; time) to produce consistent pharmaceutically recognized forms.
Contaminants and safety limits: what must be controlled
Heavy metals
Heavy metals (commonly Pb, As, Hg, Cd) must be controlled to strict limits. Methodologies and acceptance concepts are informed by ChP general chapters and international norms; for global trade, ISO 18664 provides standardized determination methods for heavy metals in herbal medicines used in TCM. Aligning your internal specs with these methods helps avoid cross-market testing friction.
Pesticide residues
Because many CMMs are cultivated, pesticide residue controls are critical. The ChP sets specific residue limits for targeted compounds and may reference national food/AG standards. GAP adoption upstream is the most efficient way to pass these limits at scale (see Section 6).
Mycotoxins and microbes
Aflatoxins and microbial limits (TAMC, TYMC, pathogens) apply based on intended use and historical risk. Proper drying, storage, and fumigation controls are assessed in both ChP tests and GMP/GSP inspections. (When fumigants like sulfur are historically used, sulfur dioxide residues are limited; modern practice discourages indiscriminate sulfur-fumigation.)
Storage and stability
To keep quality in spec across seasons and logistics, China and ISO define storage requirements. ISO 22217 covers storage of raw materials and decoction pieces—a helpful harmonized reference when designing warehouses and shelf-life protocols for export products.
5) Processing standards (炮制 paozhi) and decoction pieces (饮片)
Processing (paozhi) is a defining feature of Chinese standards. Many herbs must be processed—with vinegar, wine, honey, saline, ginger juice, or by roasting/steaming—to reduce toxicity, modify channel tropism, or enhance efficacy as historically recognized. The ChP and specialist literature enumerate these techniques and, for hundreds of herbs, define the accepted decoction piece specifications (shape, thickness, colour, moisture, extract content, and identification/assay after processing). For practitioners and manufacturers, this means the regulated item in clinical/industrial use is the processed piece, not just the raw crude drug.
Because processing changes chemistry, identity and assay are tied to the processed material: methods may specify different marker analytes or fingerprints post-processing, and yields or extractives targets shift accordingly. This puts process control (soak ratios, heating curves, solvent quality) squarely into GMP and validation territory for companies producing decoction pieces or extracts.
German National Library
6) Good Agricultural Practice (GAP): getting quality right at the source
The GAP for Chinese crude drugs addresses seed/seedling selection, Good Agricultural and Collection Practices, cultivation inputs, harvest timing, primary processing, and on-farm storage. The goal is to control geo-authenticity (道地 daodi), genetic purity, and environmental contaminants at the origin—thereby increasing pass rates for pesticide, heavy metal, and microbial tests downstream. China refreshed and re-issued GAP management requirements in 2022, reaffirming whole-process oversight for crude drug production.
For brands sourcing in multiple provinces, a GAP program with traceability (origin plots, GPS coordinates, lot coding, farmer SOPs, spray records) is often the most cost-effective way to meet ChP specs consistently—and to defend quality files with regulators and buyers.
7) Labelling, documentation, and global harmonization
If you export finished herbal products or packaged herbs, the ISO 21371 labelling standard is invaluable: it specifies the essential elements (product name, part used, processing state, lot/batch, origin, storage, cautions, dosage, etc.) for products used in TCM. Aligning ChP-compliant materials with ISO 21371 labels helps meet expectations in non-Chinese markets and reduces rework.
ISO/TC 249 has also published or proposed standards on test methods, identity/microscopy, quality and safety of raw materials, and storage—creating an international vocabulary that complements ChP and helps cross-border manufacturers unify methods and COAs.
Regionally, the HKCMMS fills gaps for common CMMs used in Hong Kong and in export trade, providing monographs with source, description, identification, tests, extractives, and assay that can be cited in dossiers or procurement specs. Its explicit goals include safety, quality, and harmonization—useful if your customers, retailers, or regulators reference Hong Kong standards.
8) What changed recently—and what to watch in 2025
2025 ChP Edition: Issued March 25, 2025, effective October 1, 2025. During the transition window, companies had to assess and align registration standards, update instructions to cite the applicable version, and submit supplementary applications if formula/process changes were needed to meet heightened requirements. Expect additional or tighter assay markers, refined fingerprints, and updates to contaminant and processing norms in selected monographs and general chapters.
GAP emphasis: Authorities continue to highlight GAP as a baseline for crude drugs, strengthening oversight of origin management and primary processing to improve downstream quality reliability.
Identity science: DNA barcoding (notably ITS2) keeps gaining traction in industrial QA and academic validation, often combined with chemical fingerprints to form multi-index identity systems—mirroring the multi-component ethos of TCM.
9) Putting it into practice: a compliance checklist for herb suppliers and brands
Approved farms/collection zones; verify species with voucher specimens.
Keep origin records (plots, harvest dates, batch coding); capture spray logs to pre-empt pesticide failures.
National Medical Products Administration
Incoming ID & purity.
Apply macro/micro ID, TLC/HPLC ID, and fingerprint vs. ChP references.
Use DNA barcoding (ITS2 ± psbA-trnH) for high-risk species, powders, or processed materials. Assay for markers.
Meet minimum content or ratio requirements per monograph, with validated HPLC/UPLC/GC methods. Contaminants: set tighter internal limits.
Heavy metals by ISO 18664/ChP; aflatoxins, microbes, and sulfur dioxide where applicable; pesticide MRLs per ChP/national rules. Processing validation (if you produce decoction pieces or extracts).
Lock paozhi parameters (media quality, soak ratios, temperatures/time) and verify post-processing identity/assay targets: the decoction piece is the regulated product.
Storage & stability.
Follow ISO 22217 and ChP guidance for humidity, temperature, and packaging; monitor shelf-life with periodic re-tests of markers and microbes.
10) Labelling & documentation for export.
Use ISO 21371 to construct labels and IFUs that satisfy non-Chinese markets; ensure COAs cite the ChP edition (e.g., 2025) and all test methods.
Cross-reference HKCMMS where relevant.
If trading through Hong Kong or serving HK/overseas buyers who cite it, map your herb list to HKCMMS monographs and note any deltas vs. ChP.