Tuesday, February 18, 2020

Tuesday, February 18, 2020

FDA Update: international cooperative arrangements


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Since the year 2000, the U.S. Food and Drug Administration has entered into 40 cooperative arrangements involving foods, pharmaceuticals or medical devices with foreign governments or partners in other nations, according to the FDA.

The agency, however, must have a confidentiality commitment in place in order to share nonpublic information with those who are part of the arrangement.

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FDA Foreign Cooperative Arrangements since 2000

Country / OrganizationSubjectEffective DateExpiration Date
MexicoSafety and Sanitary Quality of Refrigerated Fresh and Frozen Aquacultured Molluscan Shellfish Exported from the United Mexican States to the United States of America11/01/201811/1/2023
CanadaSharing Information And Facilitation of Collaborative Research Projects10/18/201710/18/2022
ChinaRegistration of U.S. Food Manufacturers Exporting to China6/15/2017Indefinite
AustraliaFood Safety Systems Recognition04/18/2017Indefinite
IrelandCertification requirements for caseins, caseinates, and mixtures exported from Ireland FDA

DAFM

08/25/201608/25/2021
CanadaFood Safety Systems Recognition05/04/2016Indefinite
New ZealandSafety and Defense of Foods for Human Consumption and Animal Feeds09/30/2015Indefinite
KoreaFresh and Fresh Frozen Molluscan Shellfish06/15/201506/15/2020
IndiaFood Safety Hindi 03/23/201503/23/2020
FranceLaw Enforcement Cooperation12/02/2014Indefinite
ChinaImplementing Arrangements:

CFDA

AQSIQ

11/21/201412/16/2014
MexicoCooperation on the Produce Safety Partnership for Fresh and Minimally Processed Produce07/24/2014Indefinite
IndiaCooperation on Medical Products02/10/201402/10/2019
ChinaFood safety risk assessment, management, and communication12/11/2013Indefinite
New ZealandFood Safety Systems Recognition12/10/2012Indefinite
BrazilCooperation to Enhance Activities of Mutual Interest

Portuguese

11/26/201211/26/2017
Australia, Brazil, and Canada (Multilateral)Cooperation in the Medical Device Single Audit Program11/17/2012Indefinite
MexicoCantaloupe

Extended

FDA-SENASICA

11/16/2012Indefinite
MexicoCantaloupe

Extended

FDA-SENASICA

08/28/201211/25/2012
MexicoSafety and Quality of Fresh and Frozen Aquacultured Molluscan Shellfish Exported from the United Mexican States to the United States of America06/26/201206/26/2017
MexicoCooperation to Enhance Activities of Mutual Interest in the Area of the Safety of Foods for Human Consumption06/13/201206/13/2017
MexicoCantaloupe

Extended

FDA-SENASICA

04/30/2012Indefinite
MexicoCantaloupe

Extended

FDA-SENASICA

10/28/201104/28/2012
Inter-American Institute for Cooperation on AgricultureTo facilitate the exchange of information and the development of projects of mutual interest04/15/201104/14/2016
ChinaCeramicware intended for use in the preparation, serving or storage of food or drink and offered for export to the United States of America11/09/201011/09/2015
MexicoCantaloupe

Extended

FDA-SENASICA

10/28/201010/28/2011
RussiaDrug Products, Good Clinical Practices05/27/2010Indefinite
ChinaSafety of drugs and medical devices12/11/200712/11/2009

Automatically Extended to:

12/11/2013

ChinaSafety of Food and feed12/11/200712/11/2017
MexicoCantaloupe

Amended

FDA

SENASICA

04/19/200710/26/2010
CanadaProprietary Software to Minimize Medication Errors12/01/200512/01/2015
CanadaSharing and Exchange of Information about Therapeutic Products12/01/2005Indefinite
MexicoCantaloupe

Original MOU

FDA - SENASICA

10/26/200510/26/2010
European Union

(EC, DG SANCO)

Food Safety09/23/2005Indefinite
SingaporeMedical Products06/24/200506/24/2010
CanadaExchange of Information About Therapeutic Products

Amended

11/18/200311/18/2013
SwitzerlandExchange of information about pharmaceutical products for human and animal use, and medical devices09/22/200309/22/2013
JapanExchange of Good Manufacturing Practices Inspection Information

12/27/2000Indefinite
AustraliaPharmaceutical Good Manufacturing Practice Inspections10/11/2000Indefinite
SpainClementines09/27/2000Indefinite
Source: U.S. Food and Drug Administration

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