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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Award Number: U01FD005690
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Geneva, 1 October 2020 Funding Opportunity RFA-FD-21-002 Project Summary International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international non-profit organisation the purpose of which is to promote public health through international harmonisation of technical requirements that contributes to the timely introduction of new medicines and continued availability of the approved medicines to patients, to the prevention of unnecessary duplication of clinical trials in humans, to the development, registration and manufacturing of safe, effective, and high quality medicines in an efficient and cost- effective manner, and to the minimisation of the use of animal testing without compromising safety and effectiveness. A major output of ICH’s work is the development of harmonised technical guidelines on Quality, Safety and Efficacy topics. The ICH Guidelines represent agreed-upon scientific guidance for meeting technical requirements for registration of pharmaceutical products. Each ICH Regulatory Member is expected to implement ICH Guidelines in line with ICH Procedures according to its national/regional requirements, with the stage of implementation of all ICH Guidelines also being dependent on when a Member joined ICH. Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus. As part of its effort to achieve global harmonised implementation of ICH Guidelines, ICH is also working on ensuring that high quality training is available based upon scientific and regulatory principles outlined in the ICH Guidelines. The ICH Secretariat provides administrative and project management support for these activities. To-date 65 harmonised ICH Guidelines on Safety, Quality and Efficacy topics, as well as Multidisciplinary topics have been developed.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE	ROUTE DE PRE-BOIS 20	GENEVA				CHE	Food and Drug Administration Research	000	9	10/10/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $302,188 )
2024	2024	INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE	ROUTE DE PRE-BOIS 20	GENEVA				CHE	Food and Drug Administration Research	000	9	7/11/2024	NON-COMPETING CONTINUATION	$302,188
														Subtotal = $302,188

Issue Date FY: 2023 ( Subtotal = $23,054 )
2023	2023	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	ROUTE DE PRE BOIS 20	GENEVE 15 AEROPORT	GE			CHE	Food and Drug Administration Research	000	8	4/14/2023	NON-COMPETING CONTINUATION	$282,271
2023	2021	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	ROUTE DE PRE BOIS 20	GENEVE 15 AEROPORT	GE			CHE	Food and Drug Administration Research	002	6	9/26/2023	COMPETING CONTINUATION	$120,406
2023	2021	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	ROUTE DE PRE BOIS 20	GENEVE 15 AEROPORT	GE			CHE	Food and Drug Administration Research	003	5	9/26/2023	SUPPLEMENT FOR EXPANSION	-$24,000
2023	2021	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	ROUTE DE PRE BOIS 20	GENEVE 15 AEROPORT	GE			CHE	Food and Drug Administration Research	004	5	9/26/2023	SUPPLEMENT FOR EXPANSION	-$10,000
2023	2020	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	ROUTE DE PRE BOIS 20	GENEVE 15 AEROPORT	GE			CHE	Food and Drug Administration Research	001	5	9/26/2023	NON-COMPETING CONTINUATION	-$216,014
2023	2019	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	ROUTE DE PRE BOIS 20	GENEVE 15 AEROPORT	GE			CHE	Food and Drug Administration Research	005	4	9/26/2023	NON-COMPETING CONTINUATION	-$129,608
														Subtotal = $23,054

Issue Date FY: 2022 ( Subtotal = $283,717 )
2022	2022	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	ROUTE DE PRE BOIS 20	GENEVE 15 AEROPORT	GE			CHE	Food and Drug Administration Research	000	7	7/13/2022	NON-COMPETING CONTINUATION	$283,717
														Subtotal = $283,717

Issue Date FY: 2021 ( Subtotal = $374,298 )
2021	2021	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	ROUTE DE PRE BOIS 20	GENEVE 15 AEROPORT	GE			CHE	Food and Drug Administration Research	000	5	1/12/2021	SUPPLEMENT FOR EXPANSION	$24,000
2021	2021	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	ROUTE DE PRE BOIS 20	GENEVE 15 AEROPORT	GE			CHE	Food and Drug Administration Research	002	5	3/31/2021	SUPPLEMENT FOR EXPANSION	$10,000
2021	2021	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	ROUTE DE PRE BOIS 20	GENEVE 15 AEROPORT	GE			CHE	Food and Drug Administration Research	001	6	3/8/2021	COMPETING CONTINUATION	$340,298
														Subtotal = $374,298

Issue Date FY: 2020 ( Subtotal = $341,450 )
2020	2020	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	ROUTE DE PRE BOIS 20	GENEVE 15 AEROPORT	GE	1215		CHE	Food and Drug Administration Research	000	5	3/25/2020	NON-COMPETING CONTINUATION	$341,450
														Subtotal = $341,450

Issue Date FY: 2019 ( Subtotal = $362,450 )
2019	2019	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	ROUTE DE PRE BOIS 20	GENEVE 15 AEROPORT	GE	1215		CHE	Food and Drug Administration Research	001	4	8/29/2019	NON-COMPETING CONTINUATION	$60,000
2019	2019	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	ROUTE DE PRE BOIS 20	GENEVE 15 AEROPORT	GE	1215		CHE	Food and Drug Administration Research	000	4	3/28/2019	NON-COMPETING CONTINUATION	$302,450
														Subtotal = $362,450

Issue Date FY: 2018 ( Subtotal = $302,450 )
2018	2018	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	CHEMIN DES MINES 9	GENEVE	GE	1202		CHE	Food and Drug Administration Research	001	3	2/8/2018	NON-COMPETING CONTINUATION	$0
2018	2018	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	CHEMIN DES MINES 9	GENEVE	GE	1202		CHE	Food and Drug Administration Research	000	3	2/6/2018	NON-COMPETING CONTINUATION	$302,450
														Subtotal = $302,450

Issue Date FY: 2017 ( Subtotal = $267,950 )
2017	2017	THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH)	CHEMIN DES MINES 9	GENEVE	GE	1202		CHE	Food and Drug Administration Research	000	2	3/24/2017	NON-COMPETING CONTINUATION	$267,950
														Subtotal = $267,950

Issue Date FY: 2016 ( Subtotal = $280,000 )
2016	2016	International Council for Harmonisation	Chemin des Mines 9	Geneva				CHE	Food and Drug Administration Research	000	1	3/28/2016	NEW	$280,000
2016	2016	International Council for Harmonisation	Chemin des Mines 9	GENEVA				CHE	Food and Drug Administration Research	001	1	6/23/2016	NEW	$0
														Subtotal = $280,000

Grand Total All Awards = $2,537,557

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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Award Number: U01FD005690

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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