ここから本文です。

守秘に関する交換文書

1. 海外規制当局
Partner Type of Arrangement Documentation Date of Signature
Nation (Region) Organization from JAPAN to JAPAN
Australia TGA Confidentiality Arrangement PDF PDF 6 Sep. 2011
Brazil ANVISA Confidentiality Arrangement PDF PDF 26 Nov. 2012
Canada Health Canada Confidentiality Arrangement PDF PDF 9 Oct. 2009
Denmark DKMA

Confidentiality Arrangement

PDF PDF 2 May. 2018
EU EC Confidentiality Arrangement
(医療機器、extended)
PDF PDF 6 Jul. 2015*1
EC Confidentiality Arrangement
(化粧品)
PDF PDF 6 Jul. 2015*1
EC/EMA Confidentiality Arrangement (extended) PDF PDF 2 Feb. 2013
EC/EMA (expired)
Confidentiality Arrangement (extended)
PDF PDF 2 Feb. 2012
EC (expired)
Confidentiality Arrangement
(医療機器)
PDF PDF 28 Oct. 2009*2
EC/EMEA (expired)
Confidentiality Arrangement
PDF PDF 2 Feb. 2007
France ANSM Confidentiality Arrangement PDF PDF 28 Nov. 2012
Ireland IMB
(currently HPRA)
Confidentiality Arrangement PDF PDF 23 Oct. 2011
Italy AIFA Confidentiality Arrangement PDF PDF 26 Nov. 2012
Netherlands MEB Confidentiality Arrangement PDF PDF 20 Nov 2014
Poland URPL WMiPB Confidentiality Arrangement PDF PDF 23 Oct. 2017
Singapore HSA Memorandum on Information Exchange PDF PDF 13 May 2010
Sweden MPA Confidentiality Arrangement PDF PDF 28 Jun. 2017
Switzerland Swissmedic Confidentiality Arrangement PDF PDF 7 Nov. 2010*3
UK MHRA Confidentiality Arrangement PDF PDF 14 Oct.2010
USA FDA Confidentiality Commitment Statement PDF PDF 15 Sep. 2004*4

 

*1 Signed by EC on 14 Jul. 2015
*2 Signed by EC on 19 Oct. 2009
*3 Signed by Swissmedic on 3 Nov. 2010
*4 Signed by MHLW on
Signed by PMDA on
23 Jul. 2004
29 Jul. 2004

 

2. 国際機関
Partner
Organization
Type of Arrangement Documentation Date of Signature
from JAPAN to JAPAN
EDQM of
the Council of Europe
Confidentiality Arrangement PDF PDF 13 Sep. 2016
USP Confidentiality Arrangement PDF PDF 20 Jun. 2017
WHO Confidentiality Arrangement PDF PDF 7 Oct. 2016*1

 

*1 Signed by PMDA on 13 Oct. 2016

 

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守秘に関する交換文書
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