Technical Dossier Evaluation on Drugs
Generic Drug
Abbreviated New Drug Application (ANDA)

According to Paragraph 1, Article 39 of the Pharmaceutical Affairs Act, drugs which are manufactured or imported are required to register with the central competent health authority (Taiwan Food and Drug Administration). No manufacturing or importation of such drugs shall be allowed until a drug permit license is approved and issued. The application for the drug registration should follow the requirements regulated in the Regulations for Registration of Medicinal Products according to Paragraph 4, Article 39 of the Pharmaceutical Affairs Act. The Regulations for Registration of Medicinal Products was promulgated on January 7, 2005, and amended several times. The information and requirements for drug registration are described in the regulation. According to Subparagraph 2, Paragraph 1, Article 4 of the Regulations for Registration of Medicinal Products, a generic drug is a pharmaceutical preparation identical to a drug which has already been approved in Taiwan in the aspects of ingredients, dosage form, contents and efficacy. The following resources provide applicants with registration information of generic drugs. Please visit “related regulations/相關法規” for more regulation of generic drugs, and “台灣藥物法規資訊網>綜合查詢” for the latest announcement.

Ⅰ.  CLASSIFICATION
  1. Please visit the TFDA’s website to ensure if the active ingredient in the medicine to be prescribed by physicians is on the list of post marketing surveillance.
  2. 1. The active ingredient in the generic drug is on the list of post marketing surveillance
  3. 2. The active ingredient in the generic drug is not on the list of post marketing surveillance
Ⅱ.  FEE:
  1. According to the latest Standards of Review Fees for the Registration of Western Medicines and Medical Devices issued by Ministry of Health and Welfare
  2. 1. The active ingredient in the generic drug is on the list of post marketing surveillance: TWD 80,000.
  3. 2. The active ingredient in the generic drug is not on the list of post marketing surveillance: TWD 50,000.
Ⅲ.  FORMS AND SUBMISSION REQUIREMENTS:
  1. Please contact the subsidiary of the company, a local agent or a Contract Research Organization (CRO) for detailed information.
Ⅳ.  NOTICE BEFORE SUBMISSION:
  1. 1. Applicants may submit requests for pre-ANDA meetings for the discussion of the format and content of the submitted document.
  2. 2. For further details, please refer to the web page of Chinese version or contact the subsidiary of the company, the local agent or the Contract Research Organization (CRO).
Ⅴ.  REVIEW TIMELINE OF ANDA:

  1. 1. Supplements or amendments for deficiencies should be submitted not later than 2 months after the issued date of the deficiency notice. If it is not possible to prepare the document within the 2 months, applicants may extend the date up to 1 month from the final date of resubmission with an application form. The extension should be no more than 1 application.
  2. 2. Applicant may submit requests for consultation via
    https://www.cde.org.tw/consultation_services/assistance_explain?id=33, if there are some concerns regarding deficiencies.
  3. 3. The review status may be inquired through https://www1.cde.org.tw/project/FlowLine_outside_query.htm or TFDA’s website https://www.fda.gov.tw/TC/cases.aspx.
Ⅵ.  FAQ