Clinical Trials | New Regulatory Developments
- 17/10/2019
- Articles
The European Commission (the EC) has been active in the field of clinical trials lately.
New Site Suitability Template
On 15 October 2019, the EC published a new “Site Suitability Template” that sponsors of clinical trials can use as part of their application dossier. Although the template was developed for use under the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014; the CTR), which, as you know, has yet to take effect, the EC emphasises that “this template is also relevant under Directive 2001/20/EC and may be used in advance of the Regulation applying”.
It is clear that it will still take some time for the CTR to enter into force. During the latest meeting of the European Medicines Agency's Management Board (the EMA Board), it became apparent that it is currently too early for the EMA Board to even consider the timing of the audit of the CTR’s underlying IT systems (i.e., the EU Clinical Trials Portal and EU Database) (see here, p. 2). Yet, the entry into force of the CTR is contingent on an audit of the EMA Board confirming that the EU Clinical Trials Portal and EU Database are fully functional.
Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products
Yesterday, the EC published guidelines on Good Clinical Practice (GCP) specific to Advanced Therapy Medicinal Products (ATMPs). The guidelines describe the GCP requirements that are specific to clinical trials conducted with ATMPs. They complement the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines on Good Clinical Practice (ICH-GCP), which are of general application. In case of discrepancies, the EC guidelines prevail.
