1.Signed on April 13, 2010;
Entered into Force on April 13, 2010.
The Taipei Economic and Cultural Office in Australia and the
Australian Commerce and Industry Office in Taipei
(hereinafter referred to as the “ Parties ” ) wish to
develop a cooperative relationship by exchanging information
in the area of therapeutic goods regulation.
This Memorandum of Understanding (MOU) will be implemented on
a) the Taipei Economic and Cultural Office in Australia by
the Taiwan Food and Drug Administration (TFDA), Taiwan.
b) the Australian Commerce and Industry Office in Taipei by
the Therapeutic Goods Administration (TGA), Australia.
The objectives of this MOU are:
a. to promote an understanding between the TFDA and the TGA
of each other ’ s regulatory requirements and processes;
b. to facilitate the exchange of information and
documentation relating to the regulation of therapeutic
c. to enable the development of collaborative activities
between the TFDA and the TGA.
3.1 In this MOU, the term “therapeutic goods” means:
a. therapeutic goods as defined in Section 3 of the
Australian Therapeutic Goods Act 1989, as amended from
time to time; and
b. pharmaceuticals and medical devices as defined in
Taiwan’s regulations. The term "medicament" as used in
the Pharmaceutical Affairs Act 2006; as amended from time
3.2 In this MOU, the term “confidential information” means
a. is by its nature confidential;
b. is designated by an implementing authority to be
c. is designated by law to be confidential, but does not
include information which is or becomes public knowledge.
4. AREA OF COOPERATION
4.1 Acting within the framework of their power, interests and
responsibilities, the Implementing Authorities will:
a. establish avenues of communication to facilitate the
exchange of information and documents about the
regulation of therapeutic goods by each implementing
authority, including policies, practices, standards,
manufacturing quality, laboratory testing, pre-market
assessment, post-market vigilance/surveillance, market
compliance and requirements for the regulation of
therapeutic goods; and
b. explore the potential for collaborative activities, which
may include the exchange of personnel, observing
inspections and the planning of joint workshops, seminars
5.1.1 Nothing in this MOU requires TFDA to release confidential
information to TGA.
5.1.2 Unless otherwise required by law, TFDA will not disclose
any information received from the TGA under this MOU,
except with the written consent of the TGA.
5.1.3 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 therapeutic
goods regulatory activities.
5.2.1 Nothing in this MOU requires the TGA to release
confidential information to TFDA.
5.2.2 Unless otherwise required by law, the TGA will not
disclose any information received from the TFDA under this
MOU, except with the written consent of the TFDA.
5.2.3 Unless otherwise required by law, the TGA will not use the
information disclosed to it under this MOU for any other
purpose than the performance of its therapeutic goods
6. FINANCIAL ARRANGEMENTS
6.1 The Implementing Authorities will be responsible for the
administration and expenditure of their respective resources
in relation to activities performed under this MOU.
6.2 The Implementing Authorities mutually determine that
activities conducted by an Implementing Authority at the
request of the other Implementing Authority, will be
provided on the basis of full cost recovery (including taxes
, duties and charges), unless otherwise mutually determined
in writing between the Implementing Authorities.
This MOU may be amended at any time by the mutual consent in
writing of the Parties.
8. SETTLEMENT OF DISPUTES
Any disputes between the Parties arising from the
interpretation or implementation of this Memorandum of
Understanding will be settled amicably through consultations
between the Parties.
9. EFFECTIVE DATE
This MOU will come into effect upon the date of the
signatures for the Parties and will continue in effect until
terminated in accordance with clause 11.
10. AGENCY CONTACT
The liaison officers responsible for the administration of
this MOU are:
a. for the TFDA, the person holding the position of Head,
Planning and Research Development Division of the TFDA;
b. for the TGA, the person holding the position of Head,
Executive Support Unit of the TGA.
11.1 Either Party may, at any time, give written notice of
termination of this MOU to the other Party. This MOU
(excepting clause 5) will terminate six months after the
date of receipt of the notice of termination by the other
11.2 The termination of this MOU will not affect the
implementation of arrangements made under it before notice
of termination was given, unless otherwise mutually
determined in writing by the Parties.
Signed at Canberra on April 13, 2010, in duplicate in the
Chinese and English languages, the two texts being equally valid
. In case of any divergence in interpretation, the English text
by the Representative of by the Representative of
the Taipei Economic and the Australian Commerce
Cultural Office in and Industry Office in
Song-Huann Lin Alice Cawte