The scope of this Reflection Paper is to clarify the practical application of requirements for clinical trials conducted outside of the EU/EEA and submitted in Marketing Authorisation Applications to the EMA (through the centralised procedure) or to National competent Authorities (through decentralised, mutual recognition, or national procedures) . The Paper set up practical steps to be undertaken during the provision of guidance and advice in the medicine development phase and during the evaluation of Marketing Authorisation Applications.
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Clinical trials – Regulation EU No 536/2014
Published by European Commission (EC)
RegulationClinical TrialsGood Clinical Practice (GCP)Good Manufacturing PracticeThe inspection of clinical trials may concern good clinical practice as regards the conduct of clinical trials as well as good manufacturing practices as regards the manufacturing of the investigational medicinal products.
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DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001
Published by Official Journal of the European Communities
Clinical TrialsGood Clinical Practice (GCP)This Directive establishes specific provisions regarding the conduct of clinical trials, including multi-centre trials, on human subjects involving medicinal products as defined in Article 1 of Directive 65/65/EEC, in particular relating to the implementation of good clinical practice. This Directive does not apply to non-interventional trials.
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