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1.Signed on December 18, 2012 Entered into force on December 18, 2012

 
Introduction:
1. The Food and Drug Administration (FDA) of Taiwan and the
Medicines and Healthcare products Regulatory Agency of the
United Kingdom of Great Britain and Northern Ireland (UK)
(the MHRA), are the regulatory authorities (collectively, the
Participants) with responsibility in their respective
countries/territories for the authorisation, granting,
renewal, variation, suspension, and revocation of licences,
certificates, or other regulatory mechanisms relating to
those medicinal products and medical devices for human use
which are clinically investigated, marketed, supplied,
manufactured, or assembled in the UK and Taiwan respectively.
2. The FDA acknowledges that the MHRA is authorized, subject to
relevant data protection requirements, to exchange
information and documentation relating to medicinal products
and medical devices in accordance with the domestic laws
under which it is constituted.
3. The Participants consider that from time to time
circumstances will arise where sharing information held by
one regulatory authority will assist the other regulatory
authority in carrying out its regulatory functions in
relation to medical devices or to ensure the safety, quality,
and efficacy of medicinal products for human use which are
under clinical investigation, authorised for marketing, or
under review for marketing authorisation in both the UK and
Taiwan.
4. The FDA will co-operate with the MHRA to facilitate the
sharing between the FDA and the MHRA of otherwise non-public
documents and information for the purposes of assisting the
FDA in carrying out its functions. This MOU sets out a
co-operation framework for the information which the FDA and
the MHRA may share with each other and the basis upon which
they may share it. Non-public documents or information means
any document or information not in the public domain that is
held by a Participant and is treated as confidential by that
Participant in accordance with the domestic laws applicable
to the Participant.
5. In this Confidentiality MOU, the term "medicinal products for
human use" excludes all medicinal products subject to
evaluation or authorised by the European Medicines Agency
(EMA) under the centralised procedure as well as medicinal
products authorised at national level by European Union
Member States that are subject to official European Union
arbitration and referrals.

Information that may be shared between the MHRA and the FDA:
6. The type of information that may be shared between the
regulatory authorities includes, but is not limited to:
I. Post-authorisation pharmacovigilance data held by one
Participant which raises safety concerns about a product
manufactured or distributed in the territory of the other
authority.
II. Information on quality defect or product recalls held by
one Participant in relation to medicinal products and
medical devices which are distributed or have been
manufactured in the territory of the other Participant.
III. Information contained in marketing authorisation
applications and applications to vary a marketing
authorisation received by one Participant which are of
significant public health interest to the other
Participant to which they are disclosed.
IV. Information contained in reports on inspections done by
one Participant which are of significant public health
interest to the other Participant to which they are
disclosed.
7. The Participants, their officials or representatives, may in
their absolute discretion limit the scope of the above
information, particularly if its dissemination or exchange
may harm the commercial interests of a third party, breach a
duty of confidence or privacy attaching to the information,
disclose a trade secret, or be contrary to the public
interest or the interests of the Participant. In some cases,
exchange of information under this understanding may be
subject to prior consent from the companies or individuals
concerned.

The basis on which this information is shared between the FDA
and the MHRA:
8. The Participants recognise that it is an essential element of
this MOU that confidential information emanating from one
Participant to the other will continue to be treated as such
by the receiving Participant, and that so far as practicable
and to the extent permitted by its respective laws, the
receiving Participant will keep the information exchanged
confidential.
9. The FDA acknowledges that some of the information it will
receive from MHRA may include non-public information exempt
from public disclosure under the relevant laws and
regulations of the UK, such as confidential information,
commercially sensitive information, trade secrets, personal
information, law enforcement information, or internal
pre-decisional information. The FDA understands that this
non-public information is shared in confidence with it, and
that the MHRA considers it critical that the FDA maintain the
confidentiality of this information. The FDA understands that
the MHRA will advise the FDA of the non-public status of the
information at the time that the information is shared.
10. The FDA understands that the MHRA affirms that the MHRA has
the authority to protect such non-public information
provided to it (including its officials and representatives)
by the FDA, and that it will protect such information as
information not to be disclosed by it under the UK Freedom
of Information Act. The FDA considers it crucial that such
non-public information should not be disclosed without the
consent of the FDA and that disclosure made without such
consent could endanger the relations between the
Participants and seriously jeopardise any further scientific
and regulatory interactions between the FDA and the MHRA.
11. The FDA understands that the MHRA is of the view that the
disclosure by the FDA of any non public information provided
to it (including its officials and representatives) by MHRA
could seriously jeopardise any further scientific and
regulatory interactions between the FDA and the MHRA and
would prejudice the relations between the MHRA and the FDA.
The FDA understands that the MHRA considers that it is
crucial that this non-public information is protected from
disclosure and that the condition of sharing this non-public
information with the FDA is that it be held in strict
confidence by the FDA.
12. The FDA affirms that it has the authority to protect
non-public information, including confidential commercial
information, provided to its officials or representatives by
the MHRA and will take all practicable steps to protect any
such non-public information from disclosure unless the owner
of the information has provided written authorisation to
make the information public or, unless in relation to the
information requested, the MHRA informs the FDA that it no
longer considers the information to be non-public or that it
no longer considers that disclosure of the non-public
information will harm relations between the MHRA and the FDA
or if the non-public information is required to be released
under applicable local law.
13. Within 5 working days of receiving from the FDA a third
party request for disclosure, the MHRA will inform the FDA
as to whether the MHRA remains of the view that the
requested disclosure should not be made and that if made it
will breach a confidence and/or endanger relations between
the Participants.
14. On each occasion where the FDA receives a request from a
third party for disclosure to that third party of non-public
information received from the MHRA, the FDA will consult
with the MHRA on that requested disclosure and understands
that the MHRA will respond to the FDA as per paragraph 13.
15. On each occasion when the MHRA receives a request from a
third party for disclosure to that third party of non-public
information received from the FDA, the FDA understands that
MHRA will consult with the FDA on that requested disclosure,
and the FDA will provide the MHRA with its position on
whether or not that non-public information should be
disclosed within 5 working days of receiving from the MHRA
any third party request for disclosure.
16. The Participants recognise that there may be occasions when
the Participant with whom confidential information is shared
may as a result of receiving that information need to take
measures to protect public health which may necessitate
sharing some or all of such confidential information with
certain other agencies. In those circumstances the
Participants will only decide to share the information in
consultation with the other Participant.
17. Both the MHRA and the FDA recognise that if requests for
information in their possession (including otherwise
non-public information received from the other Participant)
are demanded by judicial, parliamentary order or other order
issued under law, the Participant will have to surrender the
information to the court, legislature, or person concerned.
If such an order is received for otherwise non-public
information received from the other Participant, the
Participant under order to produce the information will
inform the requestor immediately and will take all measures
open to it to ensure that the information will be disclosed
in a manner that protects the information from public
disclosure.

Duration, change, and termination of Memorandum of
Understanding:
18. This MOU will come into effect on signature. It is intended
to replace any previous similar understandings between the
Participants and will continue in effect until terminated by
either Participant on 30 days written notice to the other
Participant or if mutually decided by the Participants at
any time.
19. The Participants may amend this MOU at any time by mutual
decision in writing.


Jaw-Jou Kang, Ph.D.
Director General
Food and Drug Administration

(Signed on 18/12/12 in duplicate in the English language)
資料來源:全國法規資料庫