Relevant news for those medical device manufacturers who also have pharmaceutical products: by the end of this month, on 31 January 2022, the pharma Clinical Trials Regulation (CTR) EU 536/2014 comes into application. With the Regulation, the European Commission aims to increase the efficiency and transparency of clinical trials with medicinal products and to ensure the highest standards of safety for trial participants.
The CTR replaces the existing EU Clinical Trials Directive (EC) No. 2001/20/EC and corresponding national legislation. The CTR harmonises the assessment and supervision processes for clinical trials with medicinal products throughout the EU. Key to the implementation of the CTR is the Clinical Trials Information System (CTIS) which is set up and maintained by the European Medicines Agency (EMA). The CTIS contains a centralised application portal and a publicly accessible clinical trials database. After years of delay the CTIS is now fully functional, which finally allows for the full application of the CTR on January 31st. Currently approved trials will be allowed a 3 year transition period after which they would have to comply with the new requirements (if still ongoing).
Several handy resources are available for Sponsors of clinical trials with medicinal products to help understand and comply with the requirements of the CTR:
The full text of Regulation EU 536/2014 can be found here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014R0536.
The European Commission website lists documents that are applicable to clinical trials that will be authorised under the CTR: https://ec.europa.eu/health/documents/eudralex/vol-10_en#fragment1. The set of documents include application document templates; guidance on safety reporting; templates and guidance covering quality requirements; guidance with regards to good clinical practice (GCP) inspections; additional documents and supplements.
One very useful document is the extensive Q&A document on the CTR, currently in Draft version 4.1: https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf.
A much debated area has been the application of the General Data Protection Regulation (GDPR) EU 216/679 to clinical trials. A separate Q&A document on the interplay between CTR is available here: https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf.
The CTIS Go-Live planning can be found here: https://www.ema.europa.eu/en/documents/other/european-union-clinical-trials-information-system-ctis-go-live-planning-summary-key-areas_en.pdf
The EMA offers training and support materials on the CTIS system, including the recently updated CTIS Sponsor Handbook. The Sponsor Handbook is a compilation of key guidance, technical information, recommendations and references for getting ready for use of the CTIS, including how to get access. Other useful documents include a Sponsor Quick Guide, the principles for sponsor organisation modelling and personas documents. There is also a recently updated online modular training programme. More on training offered by the EMA can be found here: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support.
Lastly, Competent Authorities have been working hard to put into place national legislation and processes to implement the Regulation. Keep an eye out for publications of the national competent authorities and changes in local requirements. In The Netherlands, for example, the Central Committee for Human Research (CCMO) has recently published a CTR decision tool to help determine whether a trial falls under the scope of the CTR (https://english.ccmo.nl/latest/news/2021/12/22/new-online-tool-makes-ctr-scope-more-transparent), and they have revised the rates for medical ethical review (https://english.ccmo.nl/latest/news/2021/09/17/rates-established-for-assessment-of-research-under-ctr-and-mdr).
Plenty of new information and changes to deal with, but hopefully the CTR and CTIS will indeed increase efficiency and transparency to clinical trials of medicinal products in Europe. The CTR and CTIS do not affect clinical trials of medical devices, which are covered by the Medical Device Regulation (MDR) EU 2017/745. The MDR also requires a central electronic databank and clinical trial application portal to be created (EUDAMED), however in contrast to the CTR, the application of the MDR went ahead on 26 May last year despite the EUDAMED system not being fully functional. If you would like to know more about medical device clinical trials, the MDR and EUDAMED, do not hesitate to contact us for further information.