The Taiwan Food and Drug Administration of Ministry of Health
and Welfare (TFDA) and the European Directorate for the Quality
of Medicines and HealthCare of the Council of Europe (EDQM),
hereinafter referred to as "the Parties", share the common goal
of protecting public health and safety by ensuring the quality
and safety of Substances for Pharmaceutical Use, i.e. Active
Pharmaceutical Ingredients (API) and Excipients that are used in
the production or preparation of medicinal products.

The Parties will co-operate as follows to facilitate the sharing
of information related to the quality and manufacture of
substances for pharmaceutical use and in particular Active
Pharmaceutical Ingredients (APIs) of common interest, including
non-public and proprietary information.
1. The information to be shared by EDQM includes:
(a) information on negative actions taken on Certificates of
suitability to the monographs of the European Pharmacopoeia
(CEPs), or applications for CEPs in the context of the EDQM
inspection programme, which includes details of the reasons
for GMP non-compliance for the companies inspected by EDQM;
(b) information on negative actions taken on CEPs, or
applications for CEPs, as a consequence of a failure from
the holder or intended holder to meet the requirements of
the Certification procedure;
(c) upon request from TFDA, information on inspections of
manufacturers of pharmaceutical substances carried out by
EDQM (typically inspections reports);
(d) upon request from TFDA, to help the assessment of licensing
applications referring to a CEP, and subject to prior
agreement of the holder of the CEP, evaluation reports for
CEP applications;
(e) information on new technical guidance.
2. The information to be shared by TFDA includes:
(a) upon request from EDQM, information on inspections of
manufacturers of pharmaceutical substances carried out by
TFDA on the Taiwanese territory or elsewhere, typically
information on outcomes of inspections or inspection
reports;
(b) information on new technical guidance or changes in
regulation.
3. Parties understand that some of the information they receive
from each other may include non-public information exempt
from public disclosure under the applicable laws and
regulations, including each Party's internal rules, such as
confidential commercial information, trade secret
information, personal privacy information, law enforcement
information or internal operational information. Both Parties
understand that this non-public information is shared in
confidence, and that it is critical that the confidentiality
of the information is maintained.
4. Both Parties shall inform each other of the non-public status
of the information at the time that the information is
shared. They shall guarantee confidentiality in accordance
with the applicable laws and regulations, including their own
internal rules.
5. TFDA and EDQM note that this Agreement relating to the
exchange of information:
(a) does not affect the authority of the Parties to carry out
their regulatory responsibilities;
(b) does not create any obligation to share information and that
each Party may decline to provide information to the other
Party.
6. Any disputes or disagreements with respect to the
interpretation or implementation of this Agreement shall be
resolved amicably by good faith negotiations between the
Parties.
7. This Agreement is to enter into force on the date of the
latter signature. Either Party may terminate this Agreement
at any time by giving a three month written notice to the
other Party.
8. This Agreement may be amended through negotiations by the
Parties.

This Agreement is signed in duplicate in English.


Taiwan Food and Drug European Directorate
Administration of for the Quality of
Ministry of Health and Medicines and
Welfare HealthCare of the
Council of Europe

＿＿＿＿＿＿＿＿＿ ＿＿＿＿＿＿＿＿＿
Dr. Ming-Kung Yeh Dr. Susanne Keitel
Director-General Director

Date: 2014. 05. 12 Date: 2014. 05. 12
Place: Taipei Place: Taipei