Key guidance documents for the Clinical Trials Regulation
Guidance documents supporting the Clinical Trials Regulation, which governs investigational medicinal product trials in the EU.
EC Clinical Trials · EU-wideEC Clinical Trials
Regulation
Category
Type
Date
Stakeholders' Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22
Public consultation on amendments to GMP guidelines for pharmaceutical manufacturing, including Chapter 4, Annex 11, and a new Annex 22.
EC Clinical Trials · EU-wideCommission staff working document on the use of titanium dioxide in medicinal products
Commission staff working document addresses the use of titanium dioxide as an excipient in medicinal products.
EC Clinical Trials · EU-wideStakeholders' Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 1
Public consultation opened on proposed amendments to EudraLex Volume 4 GMP Guidelines Chapter 1.
EC Clinical Trials · EU-wideDocument summarising evidence supporting the legislative proposal for strengthening the availability, supply and production of critical medicines within the EU
European Commission announces evidence document supporting a legislative proposal to strengthen critical medicines availability, supply and production in the EU.
EC Clinical Trials · EU-wide
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