There are currently a couple of EU clinical trials related guidelines under consultation.
Both guidelines must be considered in connection with Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, which came into force on June 20, 2014.
Since clinical trials will often be designed as multi-centre studies, potentially involving different Member States, it is the aim of both guideline to define harmonised requirements for the documentation to be submitted throughout the European Union.
The guidelines under consultation are:
| Guideline | Consultation start date | Consultation end date | Section(s) with substantial changes |
|---|---|---|---|
| Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials Revision 2 (Draft) | 1 July 2021 | 31 August 2021 | Section 9 entitled Changes to the investigational medicinal product and auxiliary medicinal product with a need to request a substantial modification to the IMPD (pages 36 – 42) |
| Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials Revision 2 (Draft) | 1 July 2021 | 31 August 2021 | Section 6 entitled Changes to the investigational medicinal product and auxiliary medicinal product with a need to request a substantial modification to the IMPD (pages 21 – 34) |
In this revision (Revision 2) of both guidelines, there are substantial changes in the section entitled Changes to the investigational medicinal product and auxiliary medicinal product with a need to request a substantial modification to the IMPD.
The main changes in this section of both guidelines (section 9 and 6 as detailed in the table above) include the following:
- A substantial modification is defined.
- More information is provided on non-substantial changes relevant to the supervision of the trial (Art 81.9 change), including when Art 81.9 changes can be submitted.
- In section 9 of the draft Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials, the table with examples for changes in IMPs containing chemically defined drug substances has also been updated significantly, with much more detail provided on substantial changes. A new column entitled Article 81.9 non-significant changes has also been added to the table.
- In section 6 of the draft Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials, a new and comprehensive table has been added in which examples are given for changes in IMPs containing biological active substances, and their classification.
How can you respond to the consultation?
You can respond to the consultation by downloading and completing the form for submission of comments on scientific guidelines here.
Source: European Medicines Agency