Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01)
The summary for the Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01) grant is detailed below.
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Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01): The Food and Drug Administration announces its intention to consider and accept a single source application for award to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The purpose of this program is to provide support in convening leading global drug regulatory agencies and pharmaceutical manufacturer associations to achieve greater harmonization of technical standards to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. The outcome of this effort will be a series of guidelines internationally recognized and categorized into four main topics:
1. Quality Guidelines: Harmonization achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.
2. Safety Guidelines: A comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity.
3. Efficacy Guidelines: The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety, and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/ pharmacogenomics techniques to produce better targeted medicines.
4. Multidisciplinary Guidelines: These are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the Common Technical Document (CTD), and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).
1. Quality Guidelines: Harmonization achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.
2. Safety Guidelines: A comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity.
3. Efficacy Guidelines: The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety, and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/ pharmacogenomics techniques to produce better targeted medicines.
4. Multidisciplinary Guidelines: These are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the Common Technical Document (CTD), and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).
Federal Grant Title: | Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01) |
Federal Agency Name: | Food Drug Administration |
Grant Categories: | Consumer Protection Food and Nutrition Health |
Type of Opportunity: | Discretionary |
Funding Opportunity Number: | RFA-FD-15-014 |
Type of Funding: | Cooperative Agreement |
CFDA Numbers: | 93.103 |
CFDA Descriptions: | Food and Drug Administration_Research |
Current Application Deadline: | Sep 30, 2015 |
Original Application Deadline: | Sep 30, 2015 |
Posted Date: | May 18, 2015 |
Creation Date: | May 18, 2015 |
Archive Date: | Oct 30, 2015 |
Total Program Funding: | $500,000 |
Maximum Federal Grant Award: | $500,000 |
Minimum Federal Grant Award: | none |
Expected Number of Awards: | 1 |
Cost Sharing or Matching: | No |
- Applicants Eligible for this Grant
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Additional Information on Eligibility
- Only the following organization is eligible to apply: International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
- Link to Full Grant Announcement
- Federal Register Notice of RFA-FD-15-014
- Grant Announcement Contact
- Lisa Ko
Grants Management Specialist
[email protected]
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