On 3rd July 2025 EMA conducted its annual meeting with representatives of industry stakeholders to address topics of evidence generation along the medicine’s life cycle and related product-development support activities, such as scientific advice and qualification, as well as specifics for paediatric and orphan medicines.
The aim of this platform is to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders.
EMA provided an update on the status of the Scientific Advice Working Party (SAWP)/Clinical Trials Coordination Group (CTCG) scientific advice pilot to date. Nine applications have been submitted to date and seven of these have been completed. Applicants’ feedback is positive as they consider that the SAWP/CTCG interaction allows harmonization of clinical trial and marketing authorization requirements, identification of issues in advance and creates expectations for fewer request for information during clinical trial application assessment. On the other hand, concerns were expressed by industry representatives regarding lack of participation in the pilot of all Member States concerned in the intended clinical trial application and, generally, in relation to the European Medicines Regulatory Network (EMRN) awareness at the time of clinical trial application of the prior advice given. Moreover, requests were made by them for involvement of ethics committees and for extension of the pilot scope to combined studies and combination products, while it was also clarified that phase 2 studies are not excluded from the pilot currently.
On the topic of more interactive and agile scientific advice, industry representatives presented a well-developed proposal for shorter timelines and lighter process for scientific advice requests restricted to few questions, involving a single area of advice and not requiring referral to other committees and working parties. EMA acknowledged that changes to development plans are sometimes observed in the course of scientific advice procedures, a fact which attests to the need for more prompt regulatory feedback. However, EMA also expressed feasibility concerns relating to the industry proposal in the current environment and with the existing IT tools. Nevertheless, EMA committed to bring the proposal to the SAWP towards possibly tripartite discussions between SAWP, EMA and industry associations for further discussions on the topic.
Finally, EMA announced an upcoming update to the scientific advice briefing document template with the main purpose of improving its use by patient representatives and enhancing their input into scientific advice. Other changes revolve mainly around special populations.
Follow-up:
- EMA to bring the proposal from developers for introducing agility into scientific advice to the SAWP, with the aim of initiating tripartite discussions to further refine the proposal and co-create a pilot framework.
- Once the update of the briefing document is progressed, sharing of the draft with the sounding board for comments.
- For the SAWP-CTCG pilot, feedback from developers to discuss further with the EMRN and address within the final pilot report, in terms of 1) clarification in guidance and 2) structural optimisation.
Pharma Design specialises in producing briefing documents for scientific advice meetings with EMA, MHRA and European regulatory authorities on behalf of sponsors. Contact us for more information at admin@pharma-design.co.uk