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Procedures news


The pharmaceutical industry is moving towards greater transparency, driven by requirements of regulatory authorities like the EMA and Health Canada.

CTIS applicable | Faster Access to Clinical Trial Information in Europe

CTIS is the single-entry point for the submission and assessment of clinical trial applications in the EU. It features a public, searchable database aimed at delivering a high level of transparency. The authorisation and oversight of clinical trials are managed by EU/EEA Member States, while the EMA maintains the CTIS. The European Commission oversees the implementation of the Clinical Trials Regulation.

Timeline Transparency Policy 0070

FLYER | Transparency Policy 0070

The EMA has progressively restarted the activities related to Policy 0070 for centrally authorised medicinal products for

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