Drug development is a long, complex and expensive process. Errors, missing documentation or unclear technical information can result in costly delays and even prevent a drug from gaining market authorisation. To help drug sponsors navigate this journey, the European Medicines Agency (EMA) offers valuable support through scientific advice and protocol assistance programs.

This article outlines the procedure drug developers must follow to receive scientific advice and protocol assistance from the EMA, highlights key steps and requirements, and explains how regulatory affairs consultants can help you make the most of these services to give your drug or medical device the best chance of success.

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Scientific advice from the EMA

The EMA offers support to drug sponsors at every stage of development via their Scientific Advice Working Party (SAWP) to facilitate the development of safe, high-quality and effective medicines within the EU.

Advice from the SAWP is available through two services:

• Scientific advice: available for all types of medicine
• Protocol assistance: scientific advice specifically for designated orphan medicines for rare diseases

The SAWP’s program is wide-ranging, but their guidance can cover topics like quality, clinical trials, methodology and overall strategy. To access this advice, developers must present a series of questions and proposed solutions in a development plan. They can then receive advice on their proposed solutions. This can help them understand anything from the best way to generate robust data about benefits and risks to designing effective clinical trials or allocating resources efficiently.

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EMA scientific advice procedure

Obtaining valuable advice from the EMA is an involved and detailed undertaking, and it takes skill and expertise to benefit fully from the service. That’s why many organisations work alongside regulatory strategy consultants to ease the process and maximise the advice available to them.

1. Determining timing

Developers must first decide when it is best to seek scientific advice. Usually, it’s most beneficial to request advice at an early stage of development, but a regulatory consultant can offer in-depth advice depending on your circumstances. You may choose to work with a consultant for just one stage of the EMA scientific advice procedure or you could work closely with them from beginning to end.

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2. Preparing for pre-submission meeting

Before formally seeking advice, developers can request a pre-submission meeting with the EMA. During this meeting, they can clarify the scope of the request, discuss the content and format of the document and ask questions about the overall procedure.

Getting the most from this meeting takes careful preparation. Here, regulatory consultants like MWB Consulting can offer valuable expertise to help you lay the groundwork for an effective meeting. They can also arrange and attend any required sessions, make sure you ask the right questions, utilise the time available effectively and help you draft responses to any queries that regulatory officials may have.

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3. Preparing the briefing document

Developers formally request advice via a briefing document which usually includes background information about the product, development plans, and specific questions and responses for EMA consideration. They submit this briefing document with supporting documentation and pay any required fees.

This is a crucial document which must be comprehensive yet concise. Regulatory strategy consultants draw on many years of experience with regulatory documentation to ensure packets like this contain the right information and are formatted correctly to help you get the best advice possible. Here, it pays to speak to an organisation like MWB Consulting as we can help you understand and benefit from the significant fee reductions that are available.

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4. Working with the SAWP

The SAWP will create a team and meet to discuss the submission. They may request additional information or clarification of the briefing document. Sometimes, the developer may be invited to a discussion meeting to discuss questions and proposed solutions directly. This typically happens in complex cases, when significant clarification is needed, or when the SAWP disagrees with the proposed plan and wants to suggest an alternative approach.

At this stage, a regulatory consultant can be an invaluable resource as they can arrange and attend this discussion meeting, suggest what questions are likely to be asked, and prepare your team so they can provide full, detailed and relevant answers.

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5. Receiving and implementing advice

Based on the SAWP’s recommendation, the final advice is adopted by the Committee for Medicinal Products for Human Use (CHMP).

Advice to developers isn’t legally binding, but following it is recommended. Deviating from this advice can lead to additional work, time and expense when seeking market authorisation, as any deviations must be justified.

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6. Following up

If a developer’s plans change significantly or new issues arise, they can request follow-up advice. This procedure is similar to the full process but will focus on the new issues and plans.

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Benefits of seeking scientific advice from the EMA

The scientific advice available within the EU is particularly beneficial for organisations developing innovative medicines or medicines where little guidance is currently available, as well as those following a unique development plan or lacking experience and expertise within the European market.

While this scientific advice isn’t a guarantee of marketing authorisation, it does help ensure that the information submitted during the process is complete, robust and appropriate. It also helps developers understand and adhere to the EU regulatory process and all its requirements, reducing the chances of time-consuming and costly queries or objections when they do seek marketing authorisation.

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Working with MWB Consulting

At MWB Consulting, our in-house team of industry experts have many years of experience working with both the EMA and SAWP. We’re available to offer ad hoc advice to troubleshoot a single stage of the scientific advice procedure or we can work in partnership with your team through the end-to-end process. We aim to help you prepare for, submit, and manage your advice request effectively so you can stay compliant with the regulatory process, reduce costs, save time and maximise the likelihood of a successful launch.