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Scientific advice and protocol assistance

Scientific advice is an opportunity to ask the regulatory authorities integral questions about your development strategy.

If you are developing a small molecule, biologic or cell and gene therapy, we can support your engagements with the following health authorities:

  • European Medicines Agency,
  • Food and Drug Administration,
  • Medicines and Healthcare Products Regulatory Agency, and
  • European National Competent Authorities.

We have decades of experience preparing for and attending scientific advice meetings throughout Europe, including national and centralised advice.

We will work with you to identify which aspects of your development plan require advice from the regulatory agencies, and at which point in development. The timing and strategy for scientific advice will depend on the timing of your clinical trials and submission of the marketing authorization application.

How we can help 

  • draft the questions and company positions for the briefing book,
  • prepare and submit the advice package to the agency, and
  • prepare for direct interactions with the agency during the advice procedure.

We can also help you draft US-specific briefing books and prepare for the Food and Drug Administration’s (FDA) questions.

Scientific Advice and Protocol Assistance (PRIME and ILAP) Resource

Download our free guide

Find out more about how to plan your scientific advice or protocol assistance, and what fee reductions are available.

FAQs

What is EMA scientific advice?

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.

What is the difference between scientific advice and protocol assistance?

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.

What are the fees for scientific advice?

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.

How do I submit scientific advice to the EMA?

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).

years of regulatory expertise

clients supported

agency interactions

orphan applications

marketing applications

We have been involved in 50+ regulatory agency interactions

4 benefits of receiving EMA Scientific Advice; how to apply and why you should

If there’s one piece of advice any regulatory specialist should give you as a medicine developer, it’s to seek scientific advice from regulatory authorities.

The European Medicines Agency (EMA) offers scientific advice at all stages of development, which is especially critical to those medicines targeted for a centralized approval in Europe.