Technical Dossier Evaluation on Drugs
Instruction Drugs and Over-the-Counter Drugs (OTC)
Medicines Instructed by Physicians, Pharmacists and/or Assistant Pharmacists and Over-the-Counter Drugs

According to Article 8 of the Pharmaceutical Affairs Act (hereafter referred as the Act), the term "preparations" shall refer to drugs which are processed and compounded from raw materials into a specific pharmaceutical form and dosage. Preparations are classified into three categories as follows: medicines to be prescribed by physicians (hereafter referred as prescription drugs), medicines instructed by physicians, pharmacists and/or assistant pharmacists (hereafter referred as instruction drugs) and over-the-counter drugs (OTC drugs).

According to Article 50 of the Act, drugs requiring a prescription of a physician shall not be dispensed or supplied in the absence of such a prescription. However, instruction drugs and OTC drugs are available without a prescription. According to Article 9 of the Act, the term "over-the-counter drugs" shall refer to drugs which are processed and manufactured from raw materials without retaining their original names, with the drugs contained therein being limited to level not in excess of the limitations of use thereof as specified by the central competent health authority, and characterized by mild action, non-accumulativeness, long storage life and easy administration, and duly indicated with their efficacy, dosage, and use, and the serial number of permit for over-the-counter drugs indicated, and which can be used for the treatment of illnesses without requiring the instructions of physicians.

Please find more information about the applications of instruction drugs and OTC drugs at Rules and Regulations or visit the website Pharmaceutical Regulations in Taiwan.

Ⅰ. CLASSIFICATIONS
  1. 1. A drug that meets one of the following criteria will be defined as an instruction drug:
  2. (1) A drug is in compliance with an instruction drug monograph of the Instruction Drug Guidance (Please refer to the Announcement No. 1081407137 issued on August 5, 2019 );or
  3. (2) A drug is not in compliance with an instruction drug monograph of the Instruction Drug Guidance; besides, there is an approved instruction drug product with the same active ingredient(s), dosage form, strength, and efficacy in Taiwan;or
  4. (3) A drug is considered to be an instruction drug under the authority of an approved New Drug Application (NDA).
  5. 2. For a drug of which active ingredients are not on the list of post marketing surveillance but requested by the central competent health authority ; or
  6. (1) An enema of which ingredient(s) and dose meet the criteria of Appendix 1 in Article 2 of the Regulations Governing Over-the-Counter Drugs and Preparations of Inherited Formulation, or a mouthwash of which ingredient(s) and dose meet Appendix 2 of the Regulations Governing Over-the-Counter Drugs and Preparations of Inherited Formulation.
  7. (2) A drug of which ingredient(s) listed in Appendix 1 (except for enemas) or Appendix 2 (except for mouthwashes) in Article 2 of the Regulations Governing Over-the-Counter Drugs and Preparations of Inherited Formulation; besides, there is an approved OTC drug product with the same active ingredient(s), dosage form, strength, and efficacy in Taiwan.
  8. (3) A drug is considered to be an OTC drug under the authority of an approved NDA.
Ⅱ. APPLICATION FEES
Application type Application fee
CLASSIFICATION i (1) (2) and CLASSIFICATION ii (1) (2) Please visit the TFDA’s website to verify whether the active ingredient(s) is on the list of post marketing surveillance before submission and please refer to Standards of Review Fees for the Registration of Western Medicines
CLASSIFICATION i (3) and CLASSIFICATION ii (3) Please refer to the NDA application fee
Ⅲ. FORMS AND SUBMISSION REQUIREMENTS
  1. Please refer to the webpage of the Abbreviated New Drug Application (ANDA) or the NDA Application to submit the application.
Application type Application fee
CLASSIFICATION i (1) (2) and CLASSIFICATION ii (1) (2) Please refer to the ANDA application
CLASSIFICATION i (3) and CLASSIFICATION ii (3) Please refer to the NDA application
  1. ★ According to the Announcement No. 1071404052, issued on May 9, 2018, for those instruction drugs and OTC drugs that are non-new chemical entities (non-NCE) or not on the list of post marketing surveillance of which API complied with Good Manufacturing Practice (GMP), the documentation can be simplified by submitting synthesis steps, process flow diagrams, specifications, analytical procedures, and certificates of analysis as a substitute for DMF. These documents should be issued by API manufacturers.
IV.FAQ