Full-chain TCM R&D services from botanical origin identification to CTD regulatory submission. Covering five core segments: Classical Prescription development, TCM compound formulations, formula granule processes, hospital preparation conversion, and TCM secondary development. CDE TCM review-oriented, providing end-to-end solutions from pharmaceutical research to regulatory approval.
The logic of TCM R&D is fundamentally different from chemical drugs — it is not a linear process of "measure content, conduct BE, submit for approval," but rather a systems engineering effort with multiple coupled variables. Botanical origin, harvesting and processing, preparation methods, extraction parameters, and formulation — deviation in any link propagates to the quality consistency of the final product. Taikomed has built full-chain capabilities from source to final product across five directions.
Based on the Catalog of Ancient Classical Prescriptions, completing full-process development from textual research, botanical origin identification, and resource assessment to pharmaceutical substance benchmarks.
Starting from clinical empirical prescriptions / renowned senior TCM practitioners' proven formulas, systematically completing pharmacological material basis, formulation process, and quality standard studies.
Using the standard decoction as a benchmark, establishing a full-process fingerprint and quantity-value transfer control system from "crude drug → prepared slices → intermediate → granules."
Using registered medical institution preparations as a foundation, systematically upgrading pharmaceutical and clinical evidence to meet new drug registration requirements.
Process improvement, dosage form modification, and indication expansion for marketed Chinese patent medicines, extending their lifecycle through the modified new drug pathway.
The simplified registration pathway for Classical Prescriptions (Category 3.1) represents the biggest policy bonus for TCM new drug applications in recent years. CDE has published 300+ Classical Prescriptions as of 2026, but the real challenge lies in converting 2,000-year-old "one liang, three qian" into quantifiable modern pharmaceutical substance benchmarks.
CDE review for Classical Prescriptions centers on consistency with ancient medical text records, demonstrated at three levels: ① Botanical origin — correspondence between ancient medicinal species and modern pharmacopoeia species; ② Preparation process — quality transfer from ancient weight-and-measure conversions to modern decoction processes; ③ Quality evaluation — full-process consistency evaluation using marker compounds plus fingerprint chromatography.
For TCM innovative drugs (Cat. 1.1/1.2) and modified new drugs (Cat. 2.1), the hardest part is answering CDE's three essential questions within a multi-component system: ① What is your pharmacological material basis? ② Why is your process designed this way? ③ How does your quality standard ensure batch-to-batch consistency?
Taikomed employs a "chemical deconstruction + activity tracking" dual-track strategy: UPLC-Q-TOF/MS for total component cluster characterization; activity-guided in vitro screening to lock in key active component clusters; spectrum-effect relationships to confirm Q-Markers for quality standard marker compound selection. This "activity-guided" methodology better aligns with CDE's review philosophy for compound formula quality control.
Taikomed's process development: ① Solvent screening based on active component cluster polarity; ② DoE optimization (Box-Behnken/CCD) for solvent multiple, time, temperature, cycles; ③ Purification via alcohol precipitation/macroporous resin/membrane separation; ④ Scale-up validation from lab 500mL to pilot 500L.
Taikomed's quality standard framework: ① Assay — simultaneous HPLC/UPLC of 2-3 marker compounds; ② Fingerprint — 10+ batches with similarity ≥0.90; ③ Specificity — TLC identification; ④ Safety — heavy metals, pesticide residues, aflatoxins, microbial limits. Forming a "marker quantitation+fingerprint qualification+TLC identification+safety" four-dimensional system.
Solution for TCM extract powder challenges (hygroscopicity, poor flowability, low compressibility): ① Physical property characterization; ② Excipient DoE optimization (lactose/MCC/mannitol); ③ Granulation method selection (wet/dry/fluid-bed); ④ Moisture-barrier film coating. Targets: flowability>8g/s, hardness>5kg, disintegration<30min, moisture uptake<5%/48h.
TCM formula granules have transitioned from pilot to full implementation, with the market shifting from expansion to quality competition. CDE's core review logic: quality consistency with the standard decoction.
The R&D workload for national (160+) and provincial standards is enormous. Each product requires: multi-origin crude drug collection→standard decoction preparation→extraction/concentration/drying/granulation→quality standards→standard decoction comparison. A single product takes 12-18 months. Taikomed's CRO services help enterprises complete pharmaceutical research for multiple products in batches, seizing the market window.
| R&D Stage | Core Work | Key Indicators | Taikomed Strategy |
|---|---|---|---|
| 1. Crude Drug Collection | 3+ origins, 15 batches | Accurate origin, strong representativeness | Established procurement network |
| 2. Prepared Slices | Per pharmacopoeia processing | ID, inspection, extractives, assay | Partner GMP slice manufacturers |
| 3. Standard Decoction | 15-batch standardized decoction+freeze-dry | Extract yield range, marker content range, transfer rate | Controlled decoction equipment |
| 4. Extraction Process | DoE: water multiple/time/temp/cycles | Transfer rate≥80%, yield in range | DoE+multi-index scoring |
| 5. Concentration & Drying | Vacuum conc./spray drying optimization | Moisture<5%, degradation<10% | Low-temp combo process |
| 6. Granulation | Dry granulation parameter optimization | Yield, PSD, solubility | Dry granulation, minimal excipients |
| 7. Quality Comparison | Standard decoction vs. granules | Similarity≥0.90, assay±30% of mean | Multi-batch complete comparison data |
Hospital preparations are the natural "incubator" for TCM new drugs — with years of clinical use backed by human-use experience data, but often lacking pharmaceutical research depth. The key challenge is upgrading "empirical compounding" to "industrial production" while supplementing standardized pharmaceutical research and clinical evidence.
Marketed Chinese patent medicines face VBP pricing, package insert revisions, and competition. TCM secondary development is not "repackaging" — it's regaining competitiveness through process improvement, dosage form upgrade, indication expansion, and new clinical evidence using the modified new drug pathway.
Upgrading legacy processes to modern extraction/purification (macroporous resin enrichment, membrane separation), improving active component content while reducing dosing. Comprehensive quality standard and fingerprint upgrades for pharmacopoeia compliance.
Traditional dosage forms (honey pills, water pills, powders) → tablets/capsules/granules. Improving compliance and efficacy, leveraging Cat. 2.1 modified new drug pathway for clinical advantage substantiation and differentiated pricing.
Using "treat different diseases with same method" principle, new pharmacodynamic studies and clinical studies to expand into new indications — e.g., cardiovascular-cerebrovascular drugs → vascular dementia.
TCM R&D requires a systematic technology platform covering crude drug research, process development, quality analysis, and regulatory submission.
Molecular identification using ITS2/psbA-trnH barcodes for multi-origin species, rapid differentiation of authentic products from counterfeits, closely related species, and substitutes. Precise species-level identification for rhubarb, coptis, licorice, etc.
High-resolution MS for rapid full-component cluster characterization — hundreds of compounds in a single run. Structural annotation via UNIFI natural product database, generating a "chemical component inventory" for the formula.
HPLC/UPLC fingerprints for 10-15 batches of multi-origin crude drugs with similarity evaluation. "Reference fingerprint+similarity threshold±3σ strategy" as core tool for process control and quality release.
Standardized preparation protocol (controlled decoction+freeze-drying), 15+ batches. Calculating marker content range (x̄±SD/x̄±30%), extract yield range, and transfer rate as benchmark for process development and quality comparison.
Box-Behnken/CCD-RSM for systematic optimization of solvent multiple, time, temperature, cycles. Multi-index comprehensive scoring as response values to establish a predictable, controllable design space.
Testing per Chinese Pharmacopoeia: heavy metals (Pb/Cd/As/Hg/Cu, ICP-MS), pesticide residues (GC-MS/MS), aflatoxins (UPLC-FLD), and microbial limits.
Since the 2020 NMPA regulations, TCM registration has five clear pathways, each with different R&D investment, review requirements, market returns, and risks.
| Category | Scope | Clinical | CMC Focus | Timeline | Market Advantage |
|---|---|---|---|---|---|
| Cat. 1.1 Innovative | New crude drugs/new formulas/new extracts | Full Phase I+II+III | Material basis, process, quality | 8-12 yr | Highest pricing+patent protection |
| Cat. 1.2 Active Ingredient | ≥90% pure compound (artemisinin, paclitaxel) | Full Phase I+II+III | Chemical drug standards | 8-12 yr | Patent+extremely high barrier |
| Cat. 2.1 Modified | Dosage form, process, indication expansion | PK+efficacy/safety | Pre/post comparison | 4-7 yr | 3-5yr monitoring+premium |
| Cat. 3.1 Classical Prescription | Catalog of Ancient Classical Prescriptions | Exempted (pharma+non-clinical safety only) | Textual research+substance benchmark | 3-4 yr | Huge cost advantage |
| Cat. 3.2 Others | Same-name same-formula, non-catalog | Case-dependent: BE/efficacy | Pharmaceutical equivalence | 4-6 yr | Moderate advantage |
TCM R&D involves the entire chain from crude drugs to regulatory submission.
DNA barcode identification, multi-origin differentiation, authentic region screening, sustainability assessment.
Learn More →Full-process from lab to pilot scale-up: extraction/concentration/drying/granulation/coating.
Learn More →Marker assay, fingerprint validation, TLC identification, safety indicator panel testing.
Learn More →Pharmacodynamic animal models, safety pharmacology, acute/chronic GLP toxicology.
Learn More →Protocol design, multi-center monitoring, real-world study data collection and analysis.
Learn More →IND/NDA CTD dossier writing, Pre-IND/Pre-NDA meeting preparation, deficiency response.
Learn More →Taikomed has built a diversified platform system covering chemical drugs, TCM, and complex injectables, with complementary technologies and shared resources.
Matrix, membrane-controlled, osmotic pump, and pulsatile release — covering all four SR/CR routes. Six-step end-to-end services.
Explore SR/CR Platform →Liposomes, nanoparticles, lipid emulsions, microemulsions — all four nano delivery systems. Supporting generics and Category 2.2 modified new drugs.
Explore Nano Platform →20+ product portfolio covering PN lipid emulsions, drug-loaded emulsions, 3-chamber bags, and Category 2.2 modified new drugs.
Explore Lipid Platform →Yes, Category 3.1 Classical Prescriptions are exempted from clinical trials based on long human-use history and clear ancient texts — but the pharmaceutical component must be robust. The substance benchmark must prove consistency, non-clinical safety (toxicology) is still required, and the quantity-value transfer logic must be rigorous. Don't cut corners — pharmaceutical data is your only proof of consistency with the ancient formulation.
It depends on registration category. Cat. 1.1 requires the deepest evidence chain: component cluster→key active components→mechanism. Cat. 2.1 and 3.2 are more relaxed but still require attribution and quantitation of primary active components. Taikomed's approach: UPLC-Q-TOF/MS for full characterization, then literature+activity screening to identify Q-Markers linked to indications, building process control and quality evaluation around these markers.
The most central aspect of formula granule R&D. Taikomed's path: ① Standard decoction parameter ranges; ② Control checkpoints at each process step; ③ Comprehensive final product vs. standard decoction comparison — content, fingerprint similarity, extract yield ratio. Key data: 15-batch standard decoction library+step-wise transfer rate data+final comparison.
It depends. CDE 2023 regulations allow human-use experience as a basis for clinical waiver if: ① Data quality is standardized with systematic efficacy and safety evaluation; ② Disease scope matches target indication; ③ Data supports the waiver level. With ≥100 cases and standardized efficacy evaluation, waiver of Phase I or small-sample Phase II may be sought.
Chemical drug CROs center on analytical chemistry+formulation+BE/clinical as a linear chain. TCM CROs require five intersecting disciplines: plant taxonomy, natural product chemistry, process engineering, analytical chemistry, and TCM-specific regulatory science. This cross-domain capability is why TCM-capable CROs are relatively scarce.
Whether Classical Prescription development, formula granule batch research, compound new drug IND, or hospital preparation conversion, Taikomed provides complete CRO services from crude drug source to CTD submission.
Inquire NowView Full-Process Services