GXP Inspection & Lab Accreditation
【Update Date:2022-04-06】unit:品質監督管理組
Information on application of GMP Compliance Assessment of API with an import drug permit license
I. Introduction:
In accordance with article 3 of Pharmaceutical Good Manufacturing Practice Regulations and The Notice (MOHW-FDA 1021150475) of “The Timetable and Measures for Implementing Good Manufacturing Practices for API manufacturers, and the regulations shall be implemented on the date of announcement” announced by the Ministry of Health and Welfare on 25 September 2013. The manufacturers of API with an import drug permit license shall fulfill the GMP requirements by 31 December 2015. Since 1 January 2016, the applicant/holder of API import permit license should apply for GMP assessment to obtained an effective approval letter issued by the TFDA, and the letter should be provided while applying for the registration, change or extension of drug import permit license.
II. Management Requirements:
1. In principle, API with drug permit license should apply for GMP compliance assessment by providing the GMP Certificate of API GMP issued by the Competent Authority of origin, with the exception for APIs of Biological medicinal products that the PMF review or on-site inspection is still required. In addition, the TFDA reserves the right of on-inspection.
2. Criteria for the API GMP Certificate recognized by the TFDA:
(1) Issuing Authority:
Competent health authorities in the country of origin of APIs (central or local authorities, depending on the actual operational mechanism in each country), PIC/S Participating Authorities, EDQM, WHO, or others that are recognized by the TFDA.
(2) GMP Standards:
The Western Pharmaceuticals Good Manufacturing Practice: Part II (PIC/S GMP Guide-Part II GMP for APIs) announced by the Ministry of Health and Welfare on 22 May 2013 or its equivalent (e.g. EU GMP Guide Part II; ICHQ7; WHO GMP for APIs).
(3) The GMP Certificate shall, at a minimum, specify:
(a) The name and address of API manufacturer
(b) API items that has being inspected
(c) Date of inspection/Issuing, and/or expiration date of the certificate
(d) The inspection is carried out in accordance with PIC/S GMP Part II or equivalent API GMP standards
(e) Signature of the issuing authority or person in charge
(4) Both the original or the photocopy of the certificate should be authenticated by the embassy, representative office or agencies authorized by the Ministry of Foreign Affairs of R.O.C., the authentication requirement may be waived if:
(a) The original certificate is issued by A10 countries, which include Germany, US, UK, France, Japan, Switzerland, Canada, Australia, Belgium, and Sweden.
(b) The certificate could be verified on the official website of issuing authority, and an affidavit indicating that the photocopies are true copies of their originals must be enclosed as well.
(5) The examples of GMP Certificates adopted by the TFDA could be refer to the official website of the TFDA (http://www.fda.gov.tw ).
3. The drug registration and GMP compliance assessment should be applied for at the same time if the API item do not have a permit license yet:
(1) For New API manufacturer which have never been registered before, it is required that at least one API item should be applied for drug registration.
(2) For registered API manufacturer which applied for validity extension, all the API items should have permit licenses or be applied for drug registration.
(3) For registered manufacturer which applied for addition of new API items, all the new items should be applied for drug registration.
4. Once the assessment has been approved, the effective approval letter would be issued by the TFDA, and the validity of the letter is in accordance with the GMP certificate. The holder of the letter should apply for extension autonomously before the expired date to prevent the right being affected, and the one which do not apply for extension would be listed for enforced management.
5. If the TFDA receives the international Rapid Alerts related to the registered API manufacturers, follow up actions related to the approval letter would be initiated in accordance to “Regulations Governing international GMP Rapid Alerts of import drugs“.
III. Documents to be enclosed (including extension of the approval letter):
1. Application Form of GMP Compliance Assessment of API with an import drug permit license (Form A)
2. Check list of contents of Site Master File (Form B)
3. Photocopy of API permit license, or application form for registration, change or extension of permit license.
4. API GMP Certificate.
5. Site Master File (SMF)
(1) The format and contents should be referred to the “Information for Preparing the Site Master File of Pharmaceutical Manufacturing Plants” announced by the TFDA.
(2) It shall be a Chinese or English version; the electronic files shall be enclosed.
IV. Receiving Unit:
Division of Quality Compliance and Management, Taiwan Food and Drug Administration
V. Review Fees:
In accordance with “The Standards of Review Fees for the Registration of Western Medicines” and “Standards of Review Fees for the Registration of orphan drug” announced by the Ministry of Health and Welfare.