Nogel, Mónika (2025) Az Európai Gyógyszerügynökség (EMA) precíziós medicinára vonatkozó jogi keretrendszere. JOG ÁLLAM POLITIKA: JOG- ÉS POLITIKATUDOMÁNYI FOLYÓIRAT, 17 (1). pp. 89-103. ISSN 2060-4580
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Abstract
Precision medicine represents a healthcare approach that utilizes patients’ molecular data – including genomic, transcriptomic, proteomic, and metabolomic information – alongside phenotypic and health data to enable targeted screening, diagnostics, and treatment options based on the most accurate data available, thereby improving the effectiveness of healthcare systems. Supporting precision medicine is in the interest of states for various reasons, as it can provide numerous social and economic benefits. This study aims to present the legal framework within which the EMA’s mechanisms related to precision medicine operate, focusing exclusively on legally relevant documents issued by EU institutions and guidelines and recommendations developed under the aegis of the EMA.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | precision medicine | European Medicines Agency | EMA | European Union law | advanced therapy medicinal products | advanced therapy methods | “-omics” |
| Subjects: | K Law / jog > K Law (General) / jogtudomány általában R Medicine / orvostudomány > RM Therapeutics. Pharmacology / terápia, gyógyszertan R Medicine / orvostudomány > RS Pharmacy and materia medica / gyógyszerészet, gyógyászati eszközök |
| SWORD Depositor: | MTMT SWORD |
| Depositing User: | MTMT SWORD |
| Date Deposited: | 05 Mar 2026 14:39 |
| Last Modified: | 05 Mar 2026 14:39 |
| URI: | https://real.mtak.hu/id/eprint/235353 |
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