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2015 Annual Report
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Risk Assessment
Management and
Research Outcomes
Cosmetics
Management
Appendix
National
Laboratory and
Testing Network
Risk Communication
and Consumer
Protection
International
Cooperation and
Cross-Strait Exchange
Food
Management
Medicinal
Products
Management
Policy and
Organization
Controlled
Drugs
Management
Medical
Devices
Management
Figure 9-2
Signing of the
Confidentiality Agreement between the Taiwan Food and Drug Administration
of Ministry of Health and Welfare and the European Directorate for the Quality of Medicines
and HealthCare of the Council of Europe
International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), as well as
other international pharmaceutical organizations and conferences.
(3) Medical Devices
Taiwan is one of the founding member of the
Asian Harmonization Working Party
(AHWP). During
2013 to 2014 TFDA served as the Vice-Chair of the AHWP as well as the Chair of the
in vitro
diagnostic device (IVDD) work group (WG2-Premarket: IVDD) under the technical committee.
A total of five international guidances for IVDD led by TFDA have been accepted as formal
documents of the AHWP organization.
2. Bilateral Activities (including of relevant agreements and memorandum
assessment)
(1) Under the common objectives and understanding of
providing the public with high-quality and safe
medicinal products
, TFDA and the European Directorate for the Quality of Medicines & Healthcare
(EDQM, Council of Europe) have both signed a
Confidentiality Agreement
on 12 May 2014 (Figure
9-2) 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.Such measures will help integrate resources of both signatories
and ensure the safety and quality of pharmaceutical substances.
TFDA also held the first joint symposium of TFDA and EDQM on 12-13 May 2014. EDQM Director
Dr. Susanne Keitel was invited as a speaker to share the latest trends and regulations for API
management in Europe, providing technical advice and consultation to Taiwan pharmaceutical