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GXP Inspection & Lab Accreditation
GMP for Medicinal Products
Follow-Up Management of Foreign Pharmaceutical Manufacturers
Management of Overseas Medicines Manufacturers
Follow-Up Management of Foreign Pharmaceutical Manufacturers
Follow-Up Management of Foreign Pharmaceutical Manufacturers
【Update Date:
2018-10-17
】
unit:品質監督管理組
In order to ensure the quality of imported medicinal products and to protect public health, GMP verification is also conducted on pharmaceutical manufacturers that export medicinal products to Taiwan for GMP compliance. There is also continuous follow-up management of foreign pharmaceutical manufacturers that have already exported medicinal products to Taiwan.
Follow-up management of manufacturers that export medicinal products to Taiwan includes: the Document Review of Validation based on the requirement of validation that was included in GMP regulations in 2003; the Document Review of PIC/S GMP Compliance based on the upgrading of the GMP standard to PIC/S GMP in 2008; and the Periodic GMP Review carried out on all Foreign Pharmaceutical manufacturers since 2012.
Document Review of Validation (application discontinued as of January 6, 2015)
Based on the fact that the requirement of validation was included in GMP regulations, between 2003 and the end of 2005, for foreign pharmaceutical manufacturers that were already been approved for GMP review, the Document Review of Validation was conducted in three stages; the manufacturers were required to complete three-stage validation review by December 10, 2005. As of January 1, 2015, PIC/S GMP has been put into effect for all pharmaceutical manufacturers that export medicinal products to Taiwan; as a result, this stage of the mission was completed. In accordance with the Ministry of Health and Welfare's official letter MOHW FDA No. 1031106493, dated January 6, 2015, the FDA has discontinued the application of Document Review of Validation to pharmaceutical manufacturers that export medicinal products to Taiwan.
Document Review of PIC/S GMP Compliance (application discontinued as of January 6, 2015)
In order for Taiwan's pharmaceutical GMP management system to be on a par with its international counterparts, the Department of Health announced on December 19, 2007, through the official letter DOH FDA No. 0961401849, the Schedule for Pharmaceutical manufacturers to Implement International GMP Standards (PIC/S GMP). This was enforced simultaneously for both local and imported medicinal products.
For foreign pharmaceutical manufacturers applying for GMP review for the first time, the Plant Master File (PMF) review or on-site inspection were conducted as per the PIC/S GMP standards, and the PIC/S GMP approval letter was issued after they were approved. For foreign pharmaceutical manufacturers that had already been approved for GMP review and which were registered within imported drug licenses, on the other hand, the Combined Measures for Pharmaceutical Manufacturers to Implement International GMP Standards (PIC/S GMP) (official letter DOH FDA No. 097140035798 dated April 24, 2008, and official letter DOH FDA No. 0981401363 dated September 30, 2009) were to be followed; they were required to apply for Document Review of PIC/S GMP Compliance and needed to complete the application before December 31, 2014. For foreign pharmaceutical manufacturers failing to undergo the review in accordance with the PIC/S GMP standards, their GMP approval letters were no longer valid; in addition if contracted manufacturing was not registered under the existing imported drug license or discontinued importation was not indicated in an affidavit, the related imported drug license was voided.
As of January 1, 2015, PIC/S GMP has been put into effect for all manufacturers of imported drugs; as a result, this stage of the mission was completed. In accordance with the Ministry of Health and Welfare's official letter MOHW FDA No. 1031106493, dated January 6, 2015, the FDA has already discontinued the application of Document Review of PIC/S GMP Compliance for manufacturers that export drugs to Taiwan.
Periodic GMP Review for Foreign Pharmaceutical Manufacturers
The National Drug Policy Conference took place on December 31, 2008. There, consistency on GMP on-site inspections, both domestically and internationally, was discussed and agreed upon. The Department of Health was also requested to establish the periodic review system for follow-up management of foreign pharmaceutical manufacturers. This was in order to achieve consistency in the management of domestic and foreign pharmaceutical manufacturers; and also the GMP status of foreign pharmaceutical manufacturers were required to be verified subsequently in order to ensure the quality of imported drugs. In light of this fact, the Ministry of Health and Welfare (formerly known as the Department of Health) has put in place the management for foreign pharmaceutical manufacturers. The amended Regulations of Medicament Manufacturer Inspection (Order DOH FDA No. 1001100780, Order MOEA IDB No. 10004604010) were promulgated July 6, 2011, adding requirements for follow-up management of foreign pharmaceutical manufacturers as per international common practice and incorporating risk assessment. The reviews take place once every two years and may be extended by one to two years (the Regulations, Article 9), depending on the drug regulation system and standards of the exported country.
In order to effectively utilize the inspection resources and enhance the efficacy of GMP review, the current Periodic GMP Review for follow-up management of foreign pharmaceutical manufacturers is both by document review and by on-site inspection based on risk assessment, in which the dosage form, the operation, the GMP review history, and the drug regulation system and standards of the exported country will be considered. The validity period will be decided and indicated on the GMP approval letters issued by TFDA. Holders of GMP approval letters should submit relevant documents and apply for Periodic GMP Review at six months prior to the expiration date of the GMP approval letters. Applicants are also required to pay fees in accordance with the Standards of Review Fees for the Registration of Western Medicines and Medical Devices (Executive Yuan, Department of Health Order DOH FDA No. 1001101530, dated March 6, 2012). The GMP approval letter issued after approval of Periodic GMP Review is used as the document to justify that the manufacturers comply with the GMP Guidelines in applying for registration of drugs, post-approval change, or extension.
As mentioned above, the holders of GMP approval letters for foreign pharmaceutical manufacturers within the validity period shall apply for Periodic GMP Review on their own initiative. In addition, for foreign pharmaceutical manufacturers approved by Document Review of PIC/S GMP Compliance, the TFDA has also included them within the Periodic GMP Review. Starting in 2012, holders of GMP approval letters for Document Review of PIC/S GMP Compliance have been informed individually at different times over three years to apply for Periodic GMP Review.
The purpose of Periodic GMP Review is to verify the status of GMP compliance of foreign manufacturers that export medicinal products to Taiwan. The Periodic GMP Review is a review for quality of manufacturing, and is a method to continuously certify the GMP of foreign manufacturers. After the introduction of Periodic GMP Review, for those holders failing to apply for Periodic GMP Review as scheduled, the GMP compliance of the foreign pharmaceutical manufacturers stated on the GMP approval letters will no longer be assured; the information on the GMP approval letters will no longer be considered valid.
Details related to the Periodic GMP Review for foreign pharmaceutical manufacturers are specified in the official letters DOH FDA No. 1001101667 dated November 1, 2011 (stipulating principles and documents submitted) and DOH FDA No. 1011100231 dated March 14, 2012 (stipulating application information), from the former Department of Health, Executive Yuan, and the official letter MOHW FDA No. 1011100231 dated May 1, 2017 (regarding alternatives for documents submitted and extensions of validity period). The TFDA holds seminars about management and review practice for foreign pharmaceutical manufacturers regularly on a yearly basis since 2012 to explain relevant regulations to domestic companies that import medicinal products into Taiwan.