What Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use - Article 10: Specific considerations for vulnerable populations requires
Organizations must give specific consideration to the assessment of clinical trial authorisation applications involving vulnerable populations such as minors, incapacitated subjects, pregnant or breastfeeding women, and other specific groups.
Pillar: Biotech & Genomics · Authority: European Parliament and Council of the European Union · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014R0536
SHA-256 integrity: a7a1db5bf4ca453faa68079a90bc10cca1daa9f0934ee79b5d53dad5acf98b28
Primary Citations — 5 traced to source
- Article 10(1): Where the subjects are minors, specific consideration shall be given to the assessment of the application for authorisation of a clinical trial on the basis of paediatric expertise or after taking advice on clinical, ethical and psychosocial problems in the field of paediatrics.
- Article 10(2): Where the subjects are incapacitated subjects, specific consideration shall be given to the assessment of the application for authorisation of a clinical trial on the basis of expertise in the relevant disease and the patient population concerned or after taking advice on clinical, ethical and psychosocial questions in the field of the relevant disease and the patient population concerned.
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