Technical Dossier Evaluation on Drugs
New Drug
Post-approval Changes in Indications, Drug Administration and Dosage

According to Article 46 of the Pharmaceutical Affairs Act, without approval of the central competent health authority, no alteration can be made to any of the originally registered particulars pertaining to any medicament approved for manufacturing or importation. In accordance with Paragraph 4, Article 39 of the Pharmaceutical Affairs Act, the application for the post-approval changes of drugs shall follow the requirements set forth in the Regulations for Registration of Medicinal Products.
The following resources provide applicants with information of post-approval changes in indications, drug administration and dosage. Please find more information at Rules and Regulations or visit the website Pharmaceutical Regulations in Taiwan.

Ⅰ. CLASSIFICATIONS
  1. 1. Post-approval changes in indications
  2. 2. Post-approval changes in drug administrations and dosages
Ⅱ. APPLICATION FEES
  1. Please refer to Standards of Review Fees for the Registration of Western Medicines
Ⅲ. FORMS AND SUBMISSION REQUIREMENTS
  1. 1. An applicant shall submit an application in accordance with Article 54 and 55 of the Regulations for Registration of Medicinal Products.
  2. 2. An applicant shall provide completed Form B and the checklist of Refuse to File (RTF) (please refer to the announcement No. 1081408566 issued on August 20, 2019).
Ⅳ. NOTICE BEFORE SUBMISSION:
  1. 1. An applicant could apply a Regulatory Consultation Services before submission to understand the requirements of regulations.
  2. 2. Contact Information:
Type Recipient Address
New application/ Re-evaluation the Food and Drug Administration
(TFDA)
(A) National Biotechnology Research Park Building F
Address:Bldg. F, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei City 115, Taiwan (R.O.C.)
(B) Joint Services Center
Address:No.161, Kunyang St., Nangang District, Taipei, 115-61, Taiwan (R.O.C.)
Applicant's response / Extension request CDE
(Original copy)
The Center for Drug Evaluation (CDE)
Address:3F No.465, Sec.6, Zhongxiao E. Rd.,
Taipei 11557, Taiwan. R.O.C
TFDA
(Duplicate copy)
(A) National Biotechnology Research Park Building F
Address:Bldg. F, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei City 115, Taiwan (R.O.C.)
(B) Joint Services Center
Address:No.161, Kunyang St., Nangang District,Taipei, 115-61, Taiwan (R.O.C.)
Ⅴ. THE REVIEW PROCESS

  1. 1. An applicant may request a one-month extension if they are unable to respond to the deficiency letter within two months of the issuance date. The applicant should request in writing an extension before the requested response date. Please note the time extension only can be requested only once.
  2. 2. An applicant may contact the project manager or submit requests for consultations via Consultation Services on Cases under Review if they have any question about the deficiency letter.
  3. 3. The review status may be inquired through the Status of the Application or the TFDA’s website https://www.fda.gov.tw/TC/cases.aspx
Ⅵ. FAQ