Since clinical trials are often designed as multi-centre studies, potentially involving different Member States, on March 2006 the European Medicines Agency (EMA) introduced the Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials to define harmonized requirements for the documentation to be submitted throughout the European Union for approval prior to beginning a clinical trial in humans.
On July 1st, a new Draft of the Guideline, which will replace the earlier version issued in 2017, has been published for public consultation. Comments on the Draft of Revision 2 of the Guideline should be provided using the appropriate template provided by the EMA and sent to QWP@ema.europa.eu by 31st of August 2021.
The section on the changes to the Investigational Medicinal Products (IMP) has been implemented aligning it with the Clinical Trial Regulation (CTR) in order to help the Sponsor in management of the amendments which can be classified as:
- Substantial modification (art 2.2.13)
- Change relevant to the supervision of the trial (art 81.9)
- Non-Substantial modification (changes outside the scope of substantial modifications and changes irrelevant to the supervision of the trial)
In particular, in the Revision 2 of the Guideline, the concept of non-substantial changes relevant to the supervision of the trial (Art 81.9 change) has been introduced: these have the purpose of updating certain, specified information in the CTIS without the need for an substantial modification application, when this information is necessary for oversight but does not have a substantial impact on patients safety and rights and/or data robustness.
RPN is available to offer companies support for the assessment on the classification of IMP amendments, as well as to provide full support for the management of IMPD documentation in compliance with the European requirements.