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1.5.2. Improving scientific tools and methods to support policy making and regulatory needs

There is a need to support research, development, integration and use of scientific tools, methods and statistics for rapid, accurate and predictive assessment of the safety, efficacy and quality of health interventions and technologies including new drugs, biologics, advanced therapies and medical devices. This is particularly relevant for new developments in domains concerning biopharmaceuticals, vaccines, antimicrobials, cell/tissue and gene therapies, organs and transplantation, specialist manufacturing, biobanks, new medical devices, combination products, diagnostic/treatment procedures, genetic testing, interoperability and e-health, including privacy aspects. Similarly, support for improved risk assessment methodologies, compliance frameworks, testing approaches and strategies relating to environment and health is required. There is also a need to support the development of relevant methods for assisting the assessment of ethical aspects of the above-mentioned domains.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-04 · Text as adopted (Official Journal); later amendments are not incorporated in this text.