This Memorandum of Understanding (MoU) made and entered into
between:

The TAIPEI ECONOMIC AND CULTURAL OFFICE in the Philippines
represented by MR. RAYMOND L.S. WANG, Representative,
hereinafter referred to as “ TECO ”; and

The MANILA ECONOMIC AND CULTURAL OFFICE in Taiwan represented by
MR. ANTONIO I. BASILIO, Resident Representative, hereinafter
referred to as “ MECO ”;

WHEREAS, desiring to promote an understanding between the Taiwan
Food and Drug Administration (TFDA) and the Food and Drug
Administration Philippines (FDAP) of each other's regulatory
requirements and processes;

WHEREAS, to facilitate the exchange of information and
documentation relating to the regulation of health products; and

WHEREAS, to enable the development of collaborative activities
between the TFDA and the FDAP;

WHEREAS, the term “ Health Product ” refers to human use
health products including food, drugs, medical devices and
cosmetics, which are regulated by TFDA and FDAP;

WHEREAS, the TECO and MECO, hereinafter referred to as “
Participants ” wish to enter into this Memorandum of
Understanding (MoU);

NOW THEREFORE, for and in consideration of the foregoing
premises, the Participants have come to the following
understanding:

PARAGRAPH I
Responsibilities of Participants
The Participants will designate respectively, a representative
agency to implement this MoU. For TECO, the implementing agency
is the Taiwan Food and Drug Administration (TFDA), and for the
MECO, the implementing agency is the Food and Drug
Administration Philippines (FDAP).

PARAGRAPH II
Areas of Cooperation
Acting within the framework of their power, interests and
responsibilities, the Implementing Agencies will:
1. Establish avenues of communication to facilitate the exchange
of information and documents about the regulation of health
products by each implementing agency, including policies,
practices, standards, manufacturing, quality, laboratory
testing, pre-market assessment, post-market surveillance,
pharmacovigilance, market compliance and requirements for the
regulation of health products;
2. Explore the potential for collaborative activities, which may
include the exchange of personnel, observing inspections and
the planning of joint workshops, seminars and meetings.
3. Develop appropriate regulatory cooperative activities,
including training programs and scientific discussions or
cooperation. Appropriate regulatory cooperative activities
may include but not limited to the following:
a. Development and coordination of the training programs for
regulatory inspectors;
b. Technical exchanges and training relating to the use of Good
Clinical Practice (GCP) to ensure the safety of human
subjects and the collection of valid clinical data; and
c. Training and exchange on the development of evaluation
methods, inspection techniques, establishment of computer
databases, evaluation report standard formats, and the
development of technical guidance documents;
4. Develop a joint research on vaccine development with focus on
technological initiatives and applied research to further
improve and promote vaccine safety.
5. Promote the participation of each agencies in international
activities concerning regulatory convergence.

PARAGRAPH III
Implementation of this MoU
1. Unless otherwise agreed upon, each Participant will be
responsible for the costs in the implementation of this MoU.
2. Financial arrangements to cover expenses for cooperative
activities under this MoU will be mutually decided upon, on a
case-to-case basis and subject to the availability of funds
and other resources.
3. The implementation of plans, programs and activities as
specified under this MoU will be subject to specific
arrangements to be mutually decided in writing.

PARAGRAPH IV
Confidentiality
1. TFDA
a. Nothing in this MoU requires TFDA to release confidential
information to FDAP.
b. Unless otherwise required by law, TFDA will not disclose
any information received from the FDAP under this MoU,
except with the written consent of the FDAP.
c. Unless otherwise required by law, the TFDA will not use the
information disclosed to it under this MoU for any other
purpose than the performance of its health product
regulatory activities.
2. FDAP
a. Nothing in this MoU requires the FDAP to release
confidential information to TFDA.
b. Unless otherwise required by law, the FDAP will not
disclose any information received from the TFDA under this
MoU, except with the written consent of the TFDA.
c. Unless otherwise required by law, the FDAP will not use the
information disclosed to it under this MoU for any other
purpose than the performance of its health product
regulatory activities.

PARAGRAPH V
Settlement of Disputes
Any disputes between the Participants arising from the
interpretation or implementation of this MoU will be settled
amicably through consultations between the Participants.

PARAGRAPH VI
Amendment
This MoU may be amended at any time by the mutual consent in
writing of the Participants.

PARAGRAPH VII
Effectivity and Duration
1. This MoU will come into effect upon the date of the last
signatures of the Participants.
2. This MoU will remain effective unless suspended or terminated
by either Participant,
a. Either Participant may suspend the application of this MoU
upon prior written notice to the other Participant of its
decision to suspend this MoU.
b. Either Participant may terminate this MoU upon three (3)
months prior written notice to the other Participant of its
decision to terminate this MoU.
3. The termination of this MoU will not affect the
implementation of any on-going activity or project before the
notice of termination was given, unless both Participants
mutually decide otherwise.

PARAGRAPH VIII
Agency Contact
The liaison officers responsible for the administration of this
MoU are:
1. for the TFDA, the person holding the position of Head,
Planning and Research Development Division of the TFDA; and
2. for the FDAP, the person holding the position of the Head of
Policy Planning Office.

IN WITNESS WHEREOF the undersigned, being duly authorized
thereto, have signed this MoU in duplicate in the Chinese and
English languages, the two texts being equally valid. In case of
any divergence in interpretation, the English text shall
prevail.


For:

THE TAIPEI THE MANILA
ECONOMIC AND ECONOMIC AND
CULTURAL OFFICE CULTURAL OFFICE
IN THE PHILIPPINES IN TAIWAN

__________________ __________________
RAYMOND L.S. WANG ANTONIO I. BASILIO

Representative Resident Representative

(Date) (Date)
Sep. 12, 2014 Sep. 12, 2014

(Place) (Place)
MAKATI CITY, MANILA MAKATI CITY, MANILA

Witnessed by:

__________________ __________________
MING-KUNG YEH, Ph.D. KENNETH Y. HARTIGAN-GO, M.D.

Director-General Director
Food and Drug Food and Drug
Administration Administration
Ministry of Health and Republic of the
Welfare Taiwan Philippines