Scientific Advice and Protocol Assistance

National scientific advice can be requested from each country’s national competent authority (NCA), which has its own process and requirements for applications, briefing materials, and fees. This advice addresses scientific or regulatory aspects of drug development, covering areas such as quality, clinical and non-clinical topics, biostatistics, and pharmacovigilance. It can be sought at any stage, from preclinical to post-authorization.

Advice meetings are now usually held virtually but can be in written form based on NCA preferences, with applicants sometimes able to choose. Key steps include submitting and validating the request, providing briefing materials, meeting with the NCA, and receiving an advice letter.

Scientific advice is the process of meeting with regulatory authorities—either the Committee for Medicinal Products for Human Use (CHMP) or national authorities individually—to discuss your product’s development programme. It is an opportunity to ask regulators questions regarding your manufacturing, non-clinical and clinical development, paediatric development, and overall development strategy. This could include dose-finding and bridging studies, and the adequacy of your proposed safety database.

National advice is limited to the national competent authority selected, and the process must be repeated individually for each national scientific advice procedure. Conversely, CHMP scientific advice encompasses a committee made up of experts drawn from all the national competent authorities. Additionally, national scientific advice often includes discursive advice (a meeting with the agency) compared to a (more commonly) written scientific advice letter from the CHMP. The CHMP may invite the applicant to a meeting, in which case, the advice letter is issued on Day 70 of the procedure as opposed to Day 40. However, such a meeting is at the discretion of the EMA/CHMP.

CHMP advice fees run into the tens and sometimes hundreds of thousands of Euros – we can help you avoid some or all of these costs using fee derogations. As a recognised SME, we can act as the orphan sponsor and provide small or medium enterprise status to reduce fees.

Any regulatory affairs consultant worth their salt will advise you to take scientific advice from the relevant regulatory authorities.

Scientific advice is available for all medicine developers, whereas protocol assistance is available for pharma and biotech companies developing orphan medicines for rare diseases. The process is the same for both, but protocol assistance allows for regulatory fee reductions.

Scientific advice fees vary depending on the scope of the advice. This is also true for the type of medicinal product being developed, and the size of the company developing the product. Fee reductions are available for small and medium-sized enterprises, orphan medicines for rare diseases and medicines developed for diseases that are public health emergencies.

You can submit your application, along with your Briefing Book, through the IRIS portal. If it’s your first interaction with the EMA, you must register with the EMA through various portals before applying for scientific advice/protocol assistance.

This includes:

1. getting your customer account number to settle fees for the scientific advice you receive,
2. registering your organization through the EMA’s organization management service (OMS),
3. delegating appropriate user access roles to apply for scientific advice through the IRIS portal, and
4. registering your medicinal product with a unique identifier called a Research Product Identifier (RPI).