EMA - Scientific advice
Scientific advice is a service offered by the European Medicines Agency (EMA) that allows medicine developers to receive guidance on the most suitable methods to ultimately achieve market authorization. This service helps increase the likelihood of successful approval for a medicine or medical technology.
When to apply?
Medicines can only be marketed once a marketing authorization has been granted. Therefore, aligning development processes with the requirements of regulatory authorities is essential to bringing therapies to patients. Scientific advice can be requested at any point during the development process, such as prior to clinical studies or before submitting a marketing authorization dossier. However, it is advisable to apply early in the process to ensure the development proceeds efficiently and smoothly.
How to apply?
1: Preparation
Prepare a document with a clear description of the product, its stage of development, and the specific questions you want addressed. EMA only responds to the questions posed by the applicant. Additionally, provide your suggested answers (applicant’s position). Adequate preparation is crucial.
2: Submission via the IRIS portal
Create an account in the EMA’s IRIS system and submit your application online, ensuring that all required documentation is included.
3: Costs
Fees are associated with applying for scientific advice. However, small and medium-sized enterprises (SMEs) and academic institutions may qualify for discounts or waivers. Discounts are also available for scientific advice related to orphan drugs.
Process
A preparatory meeting is available to refine your submission. After submission, the EMA internally drafts the advice. This may include a meeting with the applicant and patients, where the EMA may seek clarification or pose additional questions.
4: Advice report
Within a defined timeline (usually 40–70 days), you will receive a scientific advice report.
Protocol assistance for orphan products
For medicines targeting rare diseases, developers can apply for orphan drug designation. For such medicines in development, protocol assistance is available—a specialized form of scientific advice that also provides guidance on issues related to orphan drug designation, such as “significant benefit” and “clinical superiority.”
CBG tailored advice
The Dutch regulatory authority, CBG, offers a more accessible option for start-ups, small enterprises, and academic groups to request tailored advice. This process is especially suited for drug repurposing cases.
Key considerations
1: Specific questions
Formulate clear, relevant questions to ensure an efficient advice process.
2: Consistency
Ensure that the data and strategies align with current EMA guidelines and requirements.
3: SME or academic status
Verify if your organization is registered as an SME or an academic institution to potentially qualify for benefits.
More information
For detailed information on procedures and requirements, visit the official EMA website or consult the EMA guidelines on scientific advice.