LS&HC Horizons 2022 - Flipbook - Page 12
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
12
Clinical Trials
Clinical trials regulation
New clinical trials regulation brings possibilities, but also new
challenges for pharmaceutical companies conducting clinical trials in
the European Union and European Economic Area (EU/EEA): Since
the end of January 2022, clinical trials with medicinal products
in the EU/EEA are governed by a new regulatory framework, the
EU Clinical Trials Regulation (Regulation (EU) No. 536/2014, CT
Regulation), which begins replacing the prior EU Clinical Trials
Directive 2001/20/EC (CT Directive). The CT Regulation aims
to create a harmonized regulatory environment favourable for
conducting clinical trials in the European Union. While the CT
Regulation is directly applicable in the member states, national laws
are still required to fully govern clinical trials.
• The concept of co-sponsorship is formally introduced recognizing
that a clinical trial can have more than one sponsor and stipulating
the requirements the co-sponsors have to observe.
• The CT Regulation provides a transitional period allowing
pharmaceutical companies to continue, to commence (for a limited
time), and to finish clinical trials under the prior CT Directive
framework and implementing national laws. All clinical trials
conducted under the CT Directive with at least one active site in the
EU will have to be transitioned to the CT Regulation by 30 January
2025 triggering the need for a new authorization under the CT
Regulation.
Possibilities, but also challenges, arise for pharmaceutical companies
conducting clinical trials in the EU/EEA, including:
• T
he CT Regulation brings certain procedural innovations as, even
in a multinational trial, the sponsor will only be required to file one
request for authorization of the clinical trial. The involved member
states will assess the authorization request in a coordinated
procedure with each member state providing one approval covering
the approval by the national competent authority and the ethics
committee/institutional review board.
• T
he management of the clinical trial and all communications
between the sponsor and the involved member states will be done
throughout the complete life cycle of a clinical trial in a new online
portal, the Clinical Trial Information System (CTIS). The CTIS
will be used, e.g., for the authorization requests, any required
changes to the clinical trial, any requests by the member states or
the submission of annual safety reports as well as of the clinical
trial results. One aim of the CTIS is also to increase transparency in
clinical trials to the general public. Therefore, sponsor(s) need to
carefully consider which information
in the CTIS should instead remain confidential.
Arne Thiermann
Partner, Hamburg
Tina Welter-Birk
Senior Associate, Munich
