The European Union (EU) is the world’s second-largest pharmaceutical market and boasts abundant clinical resources for biopharmaceutical companies seeking global expansion. However, the region has a distinct regulatory architecture and high compliance costs, presenting challenges for developers and sponsors new to the territory.
The European Medicines Agency (EMA) allows sponsors to request Scientific Advice at various stages of drug development to ensure studies are appropriately designed and to mitigate the risk of significant pushback during the subsequent Marketing Authorisation Application (MAA) process.
The following five tips will help guide developers through the EMA’s Scientific Advice procedures.
1. Assess the Best Circumstances to Request Scientific Advice
Scientific Advice is not mandatory. However, drug developers should seek regulatory guidance when a project meets particular uncertainties:
- Gaps in existing guidance: If a sponsor is developing an innovative drug and finds a lack of sufficient details in EU guidelines for it. Also, if a sponsor is developing new or repurposed medicines targeting pathogens for which there is an unmet medical need, but little or no guidance available.
- Deviation from established norms: If a sponsor chooses to deviate from established scientific guidelines in its development plan.
- Limited regulatory experience: If the sponsor is an academic group or a micro, small, or medium-sized company, they may have limited knowledge of medical regulation and should request Scientific Advice.
Scientific advice can cover many topics. These include quality, non-clinical, and clinical aspects, methodological issues, and the overall development strategy.
2. Consider the Application Process and Timelines
The Scientific Advice Working Party (SAWP) meets monthly. Applicants must work to the EMA’s published timetables when submitting Scientific Advice requests.
In the initial planning stage, drug developers put together a briefing document for the drug. First-time applicants or developers of complex products can request a free preparatory meeting to refine their list of questions and receive preliminary guidance. The request must then be submitted by the relevant deadline.
The EMA then accepts the request, validates the documentation, and provides written advice on one of two timelines. There is either a 40-day or a 70-day procedure, depending on whether a discussion meeting is required. The time for document preparation and submission is not included.
3. Plan Out the Administrative Precursors
All Scientific Advice applications must be submitted via the EMA’s IRIS platform. Developers must follow a few short steps to do so.
1. Activate an EMA user account. This includes an individual account and an organizational account.
2. Register the organization in the Organization Management Service (OMS): This enables real-time data synchronization with IRIS.
3. Obtain an EMA customer account number: Used for payment processing, invoicing, and other financial transactions.
4. Apply for a Research Product Identifier (RPI). This must be requested via IRIS.
It’s also important to ensure the Scientific Advice briefing package is prepared in the correct format. The official Word template must be used and include the questions and the applicant’s proposed positions. The initial briefing document must be clearly marked as “DRAFT” in the filename. During the assessment phase, revised versions must be labeled “UPDATED,” and only the final submitted briefing document, confirmed by EMA, should be marked “FINAL.” Supporting study reports and references can be uploaded as compressed files.
4. Establish the Fees and Reduction Policies
Knowing the fee and reduction policies when preparing for Scientific Advice is crucial for budgeting. The fees are updated often. Depending on the scope of advice requested, fees for 2026 range from approximately EUR 51,900 to EUR 98,400.
Fee reductions are available under certain conditions. A 100% waiver is available for pediatric medicinal products, non-profit entities, and clinical trials related to pandemic vaccines or public health emergencies. Small and medium-sized enterprises registered in the European Economic Area can apply for a 90% reduction, while products with orphan designation may qualify for a 75% reduction. Advanced Therapy Medicinal Products can obtain a 65% reduction.
5. Consider FDA-EMA Parallel Scientific Advice
The EMA and U.S. regulators have established a framework for Parallel Scientific Advice (PSA), which is primarily intended for products where development guidelines are inadequate, where significant differences exist between regulators’ guidance, or for drugs addressing unmet medical needs.
To nominate a product for PSA, sponsors should address a “Request for PSA” letter to the EMA and FDA, including relevant information, including:
- The product in development
- Why a discussion with the assessors of both regulators would be beneficial
- Specific questions requiring clarification
- Desired goals for the meeting
- Explicit authorization for the agencies to exchange information relevant to the product, including trade secret information.
The process usually follows the EMA’s 70-day SAWP timeline and the FDA’s Type B meeting timeline. A teleconference or videoconference is typically scheduled around Day 60.
A Final Word on Scientific Advice for EU New Drug Applications
Scientific Advice requests are a crucial tool drug developers can use to help ensure development timelines in the EU are as smooth as possible. For sponsors unfamiliar with EU regulatory requirements, requesting critical support can reduce the risk of delays in the approval process.
As with all regulatory procedures, attention to detail is important, and understanding the process for requesting Scientific Advice will save time and money. By working with partners experienced in drug development in the E.U., drug developers can ensure they avoid the pitfalls of operating in an unfamiliar territory.
