According to Article 6 of the Pharmaceutical Affairs Act, drugs include raw materials and preparations. Additionally, according to Paragraph 1 of Article 39 of the Pharmaceutical Affairs Act, the manufacturing and importation of drugs must be filed with the central competent health authority for registration and market approval. No manufacturing or importation of such drugs shall be allowed until a drug license is approved and issued. The fourth paragraph of the same article also stipulates that applications for drug registration should follow the "Regulations for Registration of Medicinal Products". The regulation stipulates the matters to be noted and followed for various drug registration applications. 
The subsequent content will provide an overview of the process for applying to a API registration. For the latest announcements, please visit the website of Pharmaceutical Regulations in Taiwan.

I.    Documents required for application submission:
(I)    Appendices 8 and 9 of Article 42 of the Regulations for Registration of Medicinal Products.
(II)    The Type of Application Form and the Regulatory Information Form. (Refer to the announcement No. 1001405584 dated September 19, 2011, and the announcement No. 1061405824 dated June 27, 2017). 
(III)    The "API Registration and DMF Refuse to File (RTF) Checklist"  (See the announcement No. 1101407674 dated August 10, 2021).
(IV)    Tick the RTF checklist according by the type of API registration 

II.    Information to Include in the Application Letter:

(I)    Type of application: Indicate the type of application according to the API registration and DMF RTF checklist.
(II)    The name of the drug substance, the manufacturer and the site address
(III)    The statement and the tracking number of the package: If the closed (or restricted) part will be submitted directly by the drug substance manufacturer. 

I.    Applicant can choose one of the following ways to submit an application for registration:
(I)    Physical document submission: Prepare 2 copies of electronic data discs in accordance with the "CTD format" announced by the Taiwan Food and Drug Administration(TFDA) of the Ministry of Health and Welfare, and submit primarily in PDF text format.
(II)    Online submission: Submit online through the Online Application Platform (ExPress)

II.    Contact Information: 

III.    The submission information for the technical data Closed Part (Restricted Part) provided by the foreign API manufacturer is as follows. Please also attach a copy of the draft application letter from the domestic applicant.

IV.    Flowchart for API Registration Applications and Review:

Note:
(I)    If the applicant is not able to meet the deadline, a written statement should be submitted to support the application of an extension. The extended deadline is one month after the expiry date of the original correction period. Only one extension will be allowed.
(II)    If there are any questions regarding the content of the official letter, applicants can contact the project manager (PM) or apply for Review Related Consultation (RRC).
(III)    For case review status, please visit the TFDA website > Drugs > Case review status.

V.    Consultation Services

The CDE has extensive knowledge of domestic and international regulations and years of review experience. We provide diverse regulatory consultation services for industry and research departments at various stages, from drug development to market entry. We welcome all applicants to utilize these services to prepare regulatory-compliant submission documents. For application details, please see Consultation Services.

For the review fees, please refer to Standards of Review Fees for the Registration of Western Medicines.

I.    The TFDA website > Drugs > Registration Section > Application Guidelines and Checklists
II.    The TFDA website > Drugs > Inspection and Registration Section > Application Area for API Inspection and Registration > Related Announcements