Normativa europea
Regolamento (UE) n. 536/2014: LIVE!
Today, 31st January 2022, the Clinical Trials Regulation 536/2014 (CTR) is officially live!
EFPIA press release available here
the European Commission published a notice in the Official Journal of the European Union that the Clinical Trials Regulation (CTR), a new law regulating clinical trials will come into force in the EU on 31 January 2022, replacing the existing law in phases, as follows:
- 2022: Both new and old law run in parallel
- 2023: All new studies must be under the CTR
- 2025: All ongoing studies must be under the CTR
This introduces a new, EMA-hosted electronic portal (CTIS) that will manage:
- Initial application and amendments
- Notification of clinical trial milestones (such as FPFV, LPLV)
- Safety reporting
- Reporting of study results
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