Scientific advice: Difference between revisions
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Scientific advice (SA) is the most formal and detailed form of interaction between [[health technology]] developers and regulatory or HTA agencies. | Scientific advice (SA) is the most formal and detailed form of interaction between [[health technology]] developers and regulatory or HTA agencies. | ||
Scientific advice is a service provided by regulatory agencies to support companies in optimizing the development of their health technology products. This advice covers various aspects of R&D, including clinical trial design, manufacturing processes, and regulatory requirements. The primary aim is to ensure that the data generated during R&D will be robust enough to support a marketing authorization application (MAA). | |||
Scientific advice is crucial for ensuring that the device development aligns with regulatory or reimbursement expectations and scientific standards. It is the last step within a chain starting with [[Early dialogues]] and [[Early Advices]] to assure awareness of all requested requirements for market access. | This process involves comprehensive consultations to address scientific and technical questions related to the development, regulatory approval, and post-market surveillance of health technologies. The name sometimes is different according to the legal role of the regulatory/reimbursement body. | ||
Nevertheless the consultation by these bodies does have a specific topic in relation to the intended use and related legal requirements as well as in relation to comparators e.g. | |||
Other aims of Scientific advice are the impact on the quality of submissions received by the organization. Companies that utilize this service are better equipped to address regulatory requirements comprehensively, resulting in higher-quality dossiers that facilitate smoother review processes. Secondary the increase quality should reduce the time for approval. | |||
Scientific advice is crucial for ensuring that the device development aligns with regulatory or reimbursement expectations and scientific standards. It is the last step within a chain starting with [[Early dialogue|Early dialogues]] and [[Early advice|Early Advices]] to assure awareness of all requested requirements for market access. | |||
=== References === | |||
[https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance Scientific advice and protocol assistance | European Medicines Agency (europa.eu)] | |||
[https://www.fda.gov/drugs/news-events-human-drugs/fda-ema-parallel-scientific-advice-psa-program-03162022 FDA-EMA Parallel Scientific Advice (PSA) Program - 03/16/2022 | FDA] | |||
[https://www.g-ba.de/english/benefitassessment/ Benefit Assessment of Medicinal Products - Gemeinsamer Bundesausschuss (g-ba.de)] | |||
Latest revision as of 07:52, 18 July 2024
Scientific advice (SA) is the most formal and detailed form of interaction between health technology developers and regulatory or HTA agencies.
Scientific advice is a service provided by regulatory agencies to support companies in optimizing the development of their health technology products. This advice covers various aspects of R&D, including clinical trial design, manufacturing processes, and regulatory requirements. The primary aim is to ensure that the data generated during R&D will be robust enough to support a marketing authorization application (MAA).
This process involves comprehensive consultations to address scientific and technical questions related to the development, regulatory approval, and post-market surveillance of health technologies. The name sometimes is different according to the legal role of the regulatory/reimbursement body.
Nevertheless the consultation by these bodies does have a specific topic in relation to the intended use and related legal requirements as well as in relation to comparators e.g.
Other aims of Scientific advice are the impact on the quality of submissions received by the organization. Companies that utilize this service are better equipped to address regulatory requirements comprehensively, resulting in higher-quality dossiers that facilitate smoother review processes. Secondary the increase quality should reduce the time for approval.
Scientific advice is crucial for ensuring that the device development aligns with regulatory or reimbursement expectations and scientific standards. It is the last step within a chain starting with Early dialogues and Early Advices to assure awareness of all requested requirements for market access.
References
Scientific advice and protocol assistance | European Medicines Agency (europa.eu)
FDA-EMA Parallel Scientific Advice (PSA) Program - 03/16/2022 | FDA
Benefit Assessment of Medicinal Products - Gemeinsamer Bundesausschuss (g-ba.de)