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SME Briefing Meeting

 

What is it for?

It provides informal advice on the regulatory strategy of a medicinal product development and guidance on how to navigate the range of procedures and incentives available at EMA for SMEs. The service includes an informal meeting with EMA experts and staff, and company’s records of the meeting minutes with EMA comments as an outcome. An example of a follow up recommended actions is whether and when to apply to another EMA service such as scientific advice or PRIME. Some examples of topics are:

  • applying for scientific advice/protocol assistance (quality, nonclinical, clinical); 
  • regulatory and procedural topics for marketing authorisation application submission; 
  • gaining access to SME incentives; 
  • orphan drug designation and paediatric requirements; 
  • PRIME eligibility; 
  • pre/post-licensing evidence generation.

 

Who can apply? 

This support service is open to any SMEs EIC beneficiary working at any stage of development of any human and veterinary products types and therapeutics indications. 

 

How to apply?

To apply please contact SME@ema.europa.eu or the Helpline +31 (0)88 781 8787 with background information on the product, stage of development and questions to be addressed. There is no formal application form. An SME needs to have received the SME status from EMA to benefit from this free service. Please check here to find out how to obtain it. 

 

Timeline and Cost

One can apply any time and the service is free of charge to SMEs. There is not preset timeline for the service. The meeting will be set up in a timely manner once the EMA SME Office has confirmed that the questions can be addressed in an SME Briefing meeting. 

 

Learn more

To know more please watch here the recording of the EIC – EMA Info Day: Regulatory support for the development of innovative medicines and technologies offered on 31/01/2023/. The general presentation on EMA services addresses the SME briefing meeting at 43 min. The slides of the presentation (slides 11-12) can be found here. 

For more information please check: https://www.ema.europa.eu/en/human-regulatory/overview/support-smes.

 

Contact 

EMA SME contact entry point if you are still uncertain if you should apply, and when or how to apply:

SME@ema.europa.eu                        
Helpline +31 (0)88 781 8787