Taiwan

MoH:Ministry of Health and Welfare Taiwan

MoH Website:https://www.mohw.gov.tw/mp-2.html

Regulatory Authority:Taiwan food and drug Administration

Regulatory Authority website:https://www.fda.gov.tw/eng/

Local Authorised Representative:Yes

Dossier Format:Common Technical Document (CTD)

Regulation: Pharmaceutical Affairs Act

Center for Drug Evaluation, Taiwan (CDE):  https://www.cde.org.tw/eng/drugs/med_explain?id=39

New Drug Application

• A new drug application should follow the requirements according to the Regulations for Registration of Medicinal Products .
• Applicants should provide enough information to support the safety and the efficacy of the new drug.
• Also, there are expedited activities to provide access to medicines more quickly to assist patients in life-threatening situations.
• NDA submissions Rules and Regulations
• Application fees is given in Standards of Review Fees for the Registration of Western Medicines.

  New Drug Application Classification

• New Drug: New Administration Routes, New Chemical Entities (NCE)、 and New Therapeutic Compounds*
• Other New Drugs: New Dosage Form, New Dosing Regimens, New Strengths
• Biological Products: Genetically Engineered Drugs, Biosimilar Products, Vaccines, Drugs Derived from Human Blood and Plasma AllergenicProducts, others.

   

  Forms and Submission Requirements
• An applicant shall submit a New Drug Application with Form A and the Form B by referringNDA and BLA Refuse to File( RTF ) checklist
• An applicant should submit the documents according to the Regulations for Registration of Medicinal Products and its appendices.
• New Drugs: Appendix 2 and Appendix 3
• Biological Products:Appendix 6 and Appendix 7
• Radiopharmaceuticals:Appendix 10 and Appendix 11
• To understand the NDA registration requirements, an applicant may apply for a Pre-NDA Meeting, Regulatory Consultation Services, or a Module-Based Rolling Review before submission.
• An applicant should submit NDA via
• PDF format in CTD specifications
• The electronic dossier by the TFDA eCTD Builder

  New Drug Application Review Time

• NCE/ Biological Products: 360 Days
• Non-NCE with clinical efficacy and safety data: 300 Days
• Non-NCE without clinical efficacy and safety data: 200 Days

  Abbreviated New Drug Application (ANDA)/ Generic Drugs