The following update is provided by the Brandsymbol Regulatory Division. Our regulatory division is committed to providing consistent educational content and updates on Name Safety Testing Best Practices and Medication Safety Error Prevention.
European Medicines Agency (EMA) Name Review Group (NRG) interested Parties Meeting was a teleconference held on 16 November 2023 to discuss the amendments to the final version Guideline on the acceptability of names for human medicinal products processed through the centralised procedure – revision 7.
Although the joint teleconference did not allow for external presentations, there was a substantial amount of time allotted during the meeting as well as after the presentation that allowed stakeholders to ask questions and share their views.
There was a great discussion on the following major updates:
- Definition of promotional message
- Misleading therapeutic and pharmaceutical connotation
- Change to the name validity period
- NRG review process
- Inclusion of NRG decision-making checklist as Appendix for similarity-based objections
The concept of “Similarity with INNs” was made clearer by the inclusion of the following decision tree, which Clayton Tolley, Brandsymbol’s President and CEO, found to be helpful to in applying this rule:
“When comparing your proposed (invented) name with a proposed INN or recommended INN, please apply the 50% rule followed by consideration of the shared-letter string sequence, and finally, the location of the letter string within the (invented) name should be considered.”
Brandsymbol applies the INN similarity rules early in the name development process in order to help prevent similarity concerns with INNs at the time of submission. To remain current with the NRG review process, this decision tree should be part of the standard of review and perhaps also be included in the supporting documentation when submitting the proposed (invented) name.
A special thank you to the Name Review Group (NRG) for organizing a discussion for the industry to be part of the changes to this Guidance Document, and we look forward to the adoption of revision 7 by CHMP on 4 December 2023.
At Brandsymbol, we recognize the importance of staying relevant and continue to analyze the application of this Guidance to (invented) names, and we update our SafeMark® Model where appropriate. If you have any questions regarding these updates, please contact us at Regulatory@brandsymbol.com.