Dedicated to providing full-process CRO services for TCM and chemical drug hospital preparations at all levels of medical institutions — formulation development, process research, quality standards, stability evaluation, and registration submission. Transforming clinical empirical prescriptions into compliant hospital preparations through the shortest path.
Hospital preparation registration requirements are becoming increasingly stringent. Most hospital pharmacy departments face the triple pressure of limited staffing, insufficient R&D experience, and long submission timelines. Outsourcing to a professional CRO has become the choice of an increasing number of tertiary and specialized hospitals.
Provincial drug regulatory authorities have progressively tightened requirements for hospital preparation quality standards, stability data, and manufacturing process validation. Traditional pharmacy experience alone can no longer meet current registration review standards — systematic pharmaceutical research and actual process validation are essential.
Most hospital preparation rooms lack comprehensive capabilities in formulation screening, analytical method development, and stability testing. Building an independent R&D team is time-consuming and expensive. Outsourcing to a CRO provides full pharmaceutical R&D capabilities at a controllable budget.
Empirical prescriptions and agreed formulas accumulated by TCM clinicians over years are an underestimated asset. However, years of clinical use does not equal compliant evidence — human use experience must be systematically organized into pharmaceutical and non-clinical submission materials that meet regulatory authority requirements.
Traditional TCM preparation filing, chemical drug conventional registration, cross-provincial transfer… Different pathways have vastly different requirements and timelines. Choosing the wrong path can waste all prior investment. A professional CRO can provide optimal strategy recommendations at the project initiation stage.
From formulation optimization for TCM and chemical drug hospital preparations, through process development, quality standards, and stability studies, to submission dossier writing and registration filing — providing full life-cycle R&D services for hospital preparations.
Fully leveraging the filing pathway advantages for traditional TCM preparations under the Measures for the Administration of Medical Institution Preparation Registration, transforming clinical human use experience into critical evidence required for submission.
Systematic review of formulation composition, functional indications, and clinical application history; completing formulation rationality and preliminary safety assessment reports
Maintaining traditional decoction/pulverization processes while establishing modern multi-component assay and fingerprint quality control systems
Organizing clinical application data for empirical prescriptions into systematic evidence documents per regulatory authority requirements
For formulations meeting the "5+ years of use history at this institution" criterion, assisting with provincial filing pathway to significantly compress approval timeline
Covering full-process development for common chemical drug hospital preparation types including topical preparations, oral solid dosage forms, and ENT preparations.
Systematic screening of excipient types, dosage ratios, and preparation methods based on API physicochemical properties and target dosage form characteristics
From laboratory-scale trials and process parameter optimization to pilot scale-up, providing complete process development and validation reports
Analytical method development and validation for content uniformity, impurities, dissolution/release rate, and other critical quality control indicators
Accelerated testing, long-term testing, and in-use stability — all data compliant with current technical guideline requirements
Quality standards are the core of hospital preparation submissions — whether filing or registration, the depth of quality research directly determines approval rates.
| Research Module | Key Content | Deliverables |
|---|---|---|
| Analytical Method Development & Validation | Specificity and robustness validation for assay, impurity, dissolution methods | Analytical Method Validation Report |
| Quality Standard Draft | Setting specifications for description, identification, tests, and assay | Quality Standard Text and Drafting Notes |
| Accelerated Stability | 40°C±2°C / RH75%±5%, multi-timepoint testing over 0-6 months | Accelerated Stability Test Report |
| Long-Term Stability | 25°C±2°C / RH60%±10%, covering proposed shelf life | Long-Term Stability Test Report |
| Stress Testing | Stability under forced degradation conditions: high temperature, high humidity, light exposure | Stress Test Report |
Although hospital preparation submission materials are less complex than drug marketing authorization applications, format compliance and data completeness directly affect review progress.
Item-by-item writing per provincial drug regulatory authority requirements (formulation, process, quality standards, stability, labeling), ensuring format compliance
Rapidly organizing experiments and supplemental materials in response to regulatory review queries, compressing response timelines
Assisting with cross-provincial hospital preparation transfer applications and contract manufacturing (GMP facility) technical and regulatory support
Different registration pathways have significantly different requirements for submission materials, review timelines, and approval difficulty. We help evaluate the optimal pathway from the outset.
From initial consultation to certificate issuance — every step has clear deliverables and milestone controls.
Assess formulation rationality
Determine registration pathway
Develop R&D plan
Formulation screening & excipient optimization
Process parameter optimization
Pilot scale-up validation
Analytical method development
Method validation
Quality standard draft
Accelerated + long-term stability
Stress testing
In-use stability
Complete submission dossier
Formulation/Process/Quality
Stability/Labeling
Submit to provincial authority
Supplemental data responses
Post-approval handover
Hospital preparation development is not a "simplified version of drug R&D" — it has unique professional barriers in pathway selection, human use experience transformation, and regional regulatory differences.
Provincial drug authorities have significantly different review standards, material requirements, and on-site inspection rigor for hospital preparations. We have accumulated operational experience across Shaanxi, Gansu, Ningxia, Shanxi, and other provinces, enabling targeted adjustment of submission strategies.
Unlike institutions that can only handle a single category, Taikomed simultaneously possesses formulation development capabilities for both TCM (classical formulas, compound formulations, formula granules) and chemical drugs (solid dosage forms, topical preparations, injectables) — comprehensively addressing mixed hospital preparation needs.
The "human use experience" value of TCM clinical empirical prescriptions is immense — but scattered consultation records do not equal regulator-recognized evidence. We help hospitals transform fragmented clinical usage data into structured justification documents that meet registration requirements.
Every step from formulation justification to certificate issuance is completed within Taikomed, with no information loss from multi-vendor coordination. Pharmaceutical R&D, analytical testing, and regulatory affairs departments work in concert to compress the overall timeline.
Equipped with a GMP-compliant preparation pilot workshop capable of handling hospital preparation process scale-up and production validation. When necessary, we can assist in connecting with contract manufacturing (GMP) partners to meet registration production requirements.
All pharmaceutical research data, process parameters, and quality standards are executed to drug registration standards — not only meeting hospital preparation submission requirements but also preserving a complete data foundation for potential future upgrade to formal drug registration.
Four conditions must be met simultaneously: ① the formulation has 5+ years of use history at this medical institution; ② the dosage form is a traditional TCM dosage form (powders, pills, ointments, granules, etc.); ③ the formulation does not contain toxic or endangered medicinal materials; ④ the preparation process is consistent with traditional usage. Failing any single condition requires the conventional registration pathway. We help systematically evaluate each criterion at the project initiation stage.
It varies by pathway. Traditional TCM filing: pharmaceutical R&D 3-4 months + filing approval 3-4 months, totaling approximately 6-8 months. Chemical/TCM conventional registration: pharmaceutical R&D 4-6 months + stability 6 months (can be concurrent) + approval 6-12 months, totaling approximately 12-18 months. We provide a specific timeline after project evaluation.
Contract manufacturing with a GMP-certified pharmaceutical manufacturer is permitted — a contract manufacturing agreement must be signed and filed with the drug regulatory authority. We can assist in identifying and connecting with qualified GMP facilities, and provide technical transfer and process validation support.
A renewal application must be submitted 3 months before the certificate expires. Renewal requires a report on manufacturing and usage during the validity period and adverse reaction monitoring reports. Taikomed can provide technical document updates and submission services for renewal.
Yes. Hospital preparations with long usage history and sufficient human use experience — especially TCM preparations meeting classical formula criteria — have a foundation for upgrading to drug registration. In such cases, the pharmaceutical research, stability, and human use experience data from the hospital preparation can serve as supporting materials for the new drug application, significantly reducing duplicate investment.
The following must be met: ① a hospital preparation certificate has been obtained in the home province; ② a medical institution in the target province has a clinical usage demand; ③ both transferring and receiving provincial drug authorities grant approval. Key materials include quality standard verification reports and mutual agreements between both parties. We can handle the entire process on your behalf.
Whether it's a TCM agreed formula from a tertiary hospital or a chemical drug topical preparation from a specialized hospital, we help you complete filing or registration through the shortest path.
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