According to Article 8 of the Pharmaceutical Affairs Act, a preparation refers to a drug that is processed and compounded from active pharmaceutical ingredients into a specific pharmaceutical form and dosage. Preparations are classified into medicines to be prescribed by physicians (prescription drugs), medicines designated by physicians, pharmacists, and/or assistant pharmacists (instruction drugs), and over-the-counter drugs (OTC drugs). Prescription drugs, according to Article 50 of the Pharmaceutical Affairs Act, shall not be dispensed or supplied in the absence of such a prescription. Instruction drugs, which are milder in nature and have higher safety compared to prescription drugs, are available for purchase by the general public at community pharmacies and can be used with the supervision of a physician, pharmacist, or assistant pharmacist. OTC drugs (including Class B OTC drugs), as defined in Article 9 of the Pharmaceutical Affairs Act, refer to drugs that are processed and manufactured from active pharmaceutical ingredients 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 OTC drugs indicated, and which can be used for the treatment of illnesses without requiring the instructions of physicians. The following will introduce how to apply for the registration of prescription, instruction and OTC drugs. For the latest announcements, please visit the website of Pharmaceutical Regulations in Taiwan.
I. Classification of medicines:
(I) Drugs that meet one of the following conditions can be classified as instruction drugs:
1. Drugs that meet the Guidelines on the Review of Instruction Drug(The announcement No. 1081406576 dated August 5, 2019).
2. Drugs that do not meet the Guidelines on the Review of Instruction Drug; however, there are approved instruction drugs in Taiwan with the same ingredients, dosage form, strength, and efficacy that can serve as a reference for prescription.
(II) Drugs that meet one of the following conditions can be classified as OTC drugs (including Class B OTC drugs):
1. Ingredients and content comply with "Enema" in Appendix 1 (9) or "Mouthwash" in Appendix 2 (6) of Article 2 of the " Regulations Governing Over-the-Counter Drugs and Preparations of Inherited Formulation ."
2. Ingredients listed in Appendix 1 (excluding (9) Enema) or Appendix 2 (excluding (6) Mouthwash) of Article 2 of the " Regulations Governing Over-the-Counter Drugs and reparations of Inherited Formulation ," and there are approved OTC drugs in Taiwan with the same ingredients, dosage form, dosage, and efficacy.
(III) Approved NDA classified as instruction drugs or OTC drugs (including Class B OTC drugs).
II. Documents required for application:
Please follow the "ANDA Registration" or "NDA Registration" process based on the type of drug.
|
Drugs that meet the Guidelines on the Review of
Instruction Drug
|
Please follow the ANDA Registration process. |
|
Drugs that do not meet the Guidelines on the Instruction
Drug; however, there are approved Instruction Drug in
Taiwan with the same ingredients, dosage form, strength,
and efficacy that can serve as a reference.
|
|
Ingredients and content comply with "Enema" in Appendix 1 (9) or "Mouthwash" in Appendix 2 (6) of Article 2 of the "
Regulations Governing Over-the-Counter Drugs and
Preparations of Inherited Formulation."
|
|
Drugs of which the ingredients are listed in Appendix 1
(excluding (9) Enema) or Appendix 2 (excluding (6)
Mouthwash) of Article 2 of the " Regulations Governing
Over-the-Counter Drugs and Preparations of Inherited Formulation," and there are approved instruction drugs in
Taiwan with the same ingredients, dosage form, strength,
and efficacy that can serve as a reference for prescription.
|
|
For those who do not meet the above conditions and cannot apply through the ANDA Registration , please follow the NDA Registration process.
|
(I) According to the announcement on May 9, 2018 (The announcement No. 1071404052) , active pharmaceutical ingredients (API) for instruction drugs or OTC drugs that are not new chemical entities (NCE) or not on the list of post marketing surveillance, and meet the Good Manufacturing Practice (GMP) standards, can replace the technical dossier of API with the reaction steps and flow chart, specifications, analytical methods, and certificate of analysis (COA) provided by the API manufacturer.
(II) According to the announcement on March 8, 2016 (The announcement No. 1051402838), "Format and Specifications of Package Inserts and Outer Boxes for Non Prescription Drug," the format of package inserts and outer boxes for non-prescription drugs is standardized. It also requires providing measures on the outer box to assist visually impaired and elderly people in reading drug information, enhancing the readability of drug package inserts. Detailed implementation was respectively announced on March 8, 2016 (The announcement No. 1051402838), September 29, 2016 (The announcement No. 1051409381), and November 16, 2016 (The announcement No. 1051411127).
