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2014 EDQM-TFDA Agreement Signing Ceromony and Symposium

2014 EDQM-TFDA Agreement Signing Ceromony and Symposium 【Date:2014-08-06】 unit:風險管理組

The Taiwan Food and Drug Administration (TFDA) has signed a confidentiality agreement with the European Directorate for the Quality of Medicines & Healthcare (EDQM, Council of Europe) on May 12, 2014 to share non-public information regarding the quality and manufacture of Substances for Pharmaceutical Use, i.e. Active Pharmaceutical Ingredients (API) and Excipients that are used in the manufacture of medicinal products.

The agreement will facilitate the exchange of information on the procedure for ‘Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs)’ and GMP inspections of manufacturers of pharmaceutical substances. Moreover, signing of the agreement represents an important first step towards establishing close collaboration between the two Parties.

The TFDA hosted the first joint symposium of TFDA and EDQM on May 12-13, 2014 in Taipei. Three EDQM experts, including the director, Dr. Susanne Keitel, visited Taipei to offer technical advice and consultation to Taiwan pharmaceutical industry regarding application for CEPs.