Paid Consultations
To align with government policies, the CDE provides comprehensive regulatory science consultation services at all stages of drug1 development, promoting the development of and strengthening the competitiveness of Taiwan's biotechnology industry.
The CDE will establish a unique consultation team for each consultation case. This team will provide professional recommendations, plans, and regulatory pathways to overcome regulatory obstacles, accelerating the development of drugs.
The category of consultation services for drug is as follows:
| Category | Items | Applicants | ||
|---|---|---|---|---|
| Academic and Research Institutions² | Companies3 | |||
| Paid Consultations | Clinical Trial Consultations | Phase I (including CMC/non-clinical studies) | Fully subsidized4 | Charged (Schedule of fees) |
| Phase II | ||||
| Phase III | Charged (Schedule of fees) |
|||
| Phase IV | ||||
| Regulatory Strategy Consultations | BSE Strategy Consultations | |||
| NDA Strategy, including regulatory requirements and recommendations | ||||
| ANDA Strategy, including regulatory requirements and recommendations | ||||
| Other Protocol Consultation (Animal Rule related Consultation) | ||||
| IND prior assessment | ||||
| Registration Consultations | Pre-ANDA Meeting | Not applicable | ||
| Module-based rolling review | ||||
| ANDA Registration Consultation | ||||
| General Consultations | Review related consultation (RRC) | Fully subsidized | Fully subsidized | |
| General regulatory consultation | ||||
| Website of Pharmaceutical Regulations in Taiwan | ||||
| FAQ | ||||
*Fees for index case consultations are charged according to the classification in the table above. For detailed instructions, please refer to Index Case Consultation .
1. Including new drugs, generic drugs, botanical drugs, biological products, cell or gene therapy, and other emerging biotech drugs
2. For those applicants meeting one of the conditions, and the R&D results are 100% owned by the institution:
(1) Public and private colleges and universities;
(2) Public research institutions;
(3) Research institutions that are government-funded as announced by the Ministry of Civil Service;
(4) Medical institutions;
(5) Legal entities
3. Pharmaceutical/biotech companies (foreign & domestic), CRO/consulting companies, pharmaceutical agents
4. Phase I (including preclinical) and Phase II clinical trial consultations applied by legal entities, academic and research institutions, and medical institutions are currently fully subsidized. Note that strategic discussions are not held. Please submit the signed fully subsidized consultation affidavit. The affidavit can be found here