The Clinical Trial Regulation: Get Ready for Go-Live – Part 2
Regulation (EU) no. 536/2014 on clinical trials on medicinal products for human use streamlines and digitises the processing of trials via a Clinical Trials Information System.
Read Part 1 of the “The Clinical Trial Regulation: Get Ready for Go-Live” series here.
Clinical Trials Information System
Regulation (EU) no. 536/2014 on clinical trials on medicinal products for human use (the “Clinical Trial Regulation”) streamlines and digitises the processing of trials via a Clinical Trials Information System (“CTIS”). On 31 July 2021, the Commission confirmed the introduction of the CTIS no later than 31 January 2022.
CTIS will be a centralised European database and single entry point for the submission of all clinical trial information in the EU. It is designed to harmonise the submission, assessment and supervision of trials, facilitate greater regulatory oversight and provide increased transparency of trial information.
CTIS will support the day-to-day business processes of Competent Authorities and sponsors throughout the life cycle of a clinical trial. It will be a role-based system featuring three main components to fulfil the needs of its different users:
- Submission Workspace – for clinical trial sponsors to compile and submit data / information.
- Authority Workspace – collaborative space for EU Member States and the Commission to support the evaluation of data / information submitted by the sponsors, to submit assessment reports and to manage requests for information.
- Public Website – for public to access available data and information relating to clinical trials in the EU.
The authorisation of clinical trials will remain the responsibility of the Member States but the European Medicines Agency (“EMA”) will manage CTIS and the publication of content on its website.
Authorisation for a Clinical Trial
In order to obtain authorisation for a clinical trial, a sponsor must submit a single set of documents to the Competent Authority of the Member State in which it intends to submit the clinical trial application (“CTA”). Where the CTA is multi-jurisdictional, the sponsor must nominate a single Reporting Member State (“RMS”) to which it submits the CTA documents and whose role is to assess the CTA. This represents a significant departure from the previous requirement that a separate CTA needed to be submitted to each Member State Concerned (“MSC”).
The authorisation procedure will be split into two stages:
- Part I – a co-ordinated scientific assessment of the CTA by the RMS and all MSCs.
- Part II – an ethical assessment of country-specific and site-specific documents by each MSC according to its own territorial requirements.
Following this procedure, each MSC will reach its own outcome and notify the sponsor through CTIS whether the clinical trial is authorised, authorised subject to conditions, or refused.
The entire process takes place within a maximum timeline of 60 days and is broken down into three phases following submission of the CTA:
- Validation: 10 days
- Assessment: 45 days
- Final Decision: 5 days
Modifications, amendments and safety reporting may also be submitted post-authorisation through CTIS.
The Health Products Regulatory Authority (“HPRA”) is the competent authority for approval of CTAs in Ireland and will lead the national scientific assessment set out in Part I above.
The National Office for Research Ethics Committee for Clinical Trials (“NREC-CT”) is the responsible body for the ethical assessment set out in Part II above. It will also co-ordinate with HPRA to select the RMS and will have input on the Part I decision.
The authorisation constitutes a single national decision to be issued by the HPRA to the sponsor through CTIS and will incorporate the HPRA Part I assessment and the NREC-CT Part II assessment.
Appeals must be submitted to the HPRA within 28 days of the final decision. The HPRA will handle the appeal but may consult the NREC-CT as appropriate.
If you would like to know more about the legal, regulatory and contractual aspects of clinical trials in Ireland, please contact Colin Kavanagh or Bridget McGrath.