The Directors and Consultants at Kinesys all have many years of preparing and filing successful CTAs around Europe, as well as a range of INDs in USA.
The conduct of clinical trials in the EU is currently governed by the Clinical Trials Directive (2001/20/EC). However, the legislation will undergo a major change when the Clinical Trial Regulation EU No. 536/2014 comes into force in 2019.
The Regulation EU No. 536/2014 harmonises the assessment and supervision processes for clinical trials throughout the EU, via an EU portal and database. The European Medicines Agency (EMA) will set up and maintain the portal and database, in collaboration with the Member States and the European Commission. This Regulation features:
- A streamlined application procedure for all clinical trials conducted in Europe via a single EU portal and database. All applicants must be registered before assessment
- A single authorisation procedure for all clinical trials, to allow a faster and more thorough assessment by all concerned EU countries
- The extension of the silent agreement principle to the authorisation process giving more legal certainty to sponsors and researchers, in particular SMEs and academics
- Strengthened transparency for clinical trials data
The major benefit to sponsors will come from submitting a single application in electronic format leading to coordinated assessment and approval in multiple countries within a defined timeline.
Although the Regulation entered into force on 16 June 2014 the timing of its application depends on the development of a fully functional EU portal and database by the EMA together with the EU countries and the Commission. It is estimated that the new regulation will come into force during 2019.
In preparation for the new regulation some member states are offering pilot or transition schemes for submission of CTAs. Kinesys understands that NCAs will be keen for sponsors to use these schemes and they have the advantage of providing CTA and Ethics approval simultaneously.
Kinesys has the experience of submitting CTAs through the current regulation and also through the new pilot or transition schemes. Kinesys’ Regulatory Consultants can help you prepare, review and submit your application to the Competent Authorities and Ethic Committees, as well as help you address any validation queries or grounds for non-acceptance (GNAs) that may arise from the review of your CTA Application.