Regulation (EU) No 536/2014
E553848
Regulation (EU) No 536/2014 is the European Union’s main legal framework governing the conduct, authorization, and oversight of clinical trials on medicinal products for human use.
Statements (51)
| Predicate | Object |
|---|---|
| instanceOf |
European Union regulation
ⓘ
clinical trials regulation ⓘ |
| abbreviation | CTIS NERFINISHED ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| adoptionDate | 2014-04-16 ⓘ |
| aimsTo |
ensure the reliability and robustness of clinical trial data
ⓘ
harmonise rules on clinical trials across EU Member States ⓘ increase transparency of clinical trial information ⓘ protect the rights, safety and well-being of clinical trial subjects ⓘ simplify and streamline clinical trial authorisation procedures ⓘ |
| applicableFrom | 2022-01-31 ⓘ |
| appliesIn | all EU Member States ⓘ |
| appliesTo |
clinical trials conducted in the European Union
ⓘ
medicinal products for human use ⓘ |
| contains |
rules on clinical trials in emergency situations
ⓘ
rules on clinical trials involving incapacitated subjects ⓘ rules on clinical trials involving minors ⓘ rules on inspection of clinical trials ⓘ rules on labelling of investigational medicinal products ⓘ rules on low-intervention clinical trials ⓘ rules on manufacturing and import of investigational medicinal products ⓘ rules on safety reporting and pharmacovigilance in clinical trials ⓘ |
| directlyApplicable | yes ⓘ |
| enteredIntoForceDate | 2014-06-16 ⓘ |
| establishes |
EU database for clinical trials
ⓘ
EU portal for clinical trial applications ⓘ |
| fullName | Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use NERFINISHED ⓘ |
| implementedThrough | Clinical Trials Information System NERFINISHED ⓘ |
| introduces |
coordinated assessment procedure between Member States
ⓘ
risk-based approach to clinical trial oversight ⓘ |
| legalBasis | Treaty on the Functioning of the European Union ⓘ |
| number | 536/2014 ⓘ |
| OJReference | OJ L 158, 27.5.2014, p. 1–76 ⓘ |
| policyArea |
clinical research
ⓘ
pharmaceuticals ⓘ public health ⓘ |
| publicationDate | 2014-05-27 ⓘ |
| publishedIn | Official Journal of the European Union NERFINISHED ⓘ |
| relevantAuthority |
European Medicines Agency
NERFINISHED
ⓘ
national competent authorities of Member States ⓘ |
| repeals | Directive 2001/20/EC NERFINISHED ⓘ |
| requires |
ethics committee involvement in clinical trial assessment
ⓘ
informed consent of clinical trial subjects ⓘ publication of clinical trial information in a public database ⓘ safety reporting of serious adverse events ⓘ single EU-wide clinical trial application per trial ⓘ submission of summary of clinical trial results ⓘ |
| shortName |
CTR
ⓘ
EU Clinical Trials Regulation NERFINISHED ⓘ |
| subjectMatter | clinical trials on medicinal products for human use ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.