Obtaining marketing authorisation in Europe can be a complex and lengthy process — particularly for small to mid-sized biotech and pharma companies operating outside the European Union (EU).
The process requires careful planning, extensive documentation and a thorough understanding of the European regulatory framework. However, companies can significantly increase their chances of obtaining EMA marketing authorisation by working closely with a pharma services company to tap into relevant regulatory expertise.
Here are six steps you can take to help streamline the process and get your product to market faster and more cost-effectively…
1. Consult a regulatory expert
Before initiating the process, it’s important to consult with a regulatory expert who is familiar with the European regulatory framework. An experienced pharma services company with local knowledge can provide guidance on the regulatory requirements and processes for obtaining marketing authorisation in Europe — helping you identify any potential challenges or obstacles that may need to be addressed.
2. Determine the appropriate regulatory pathway
The regulatory pathway for obtaining EMA marketing authorisation will depend on the type of product being developed and the stage of development. In general, there are two regulatory pathways: the centralised procedure, which is required for biological products and products for rare diseases, and the decentralised or national procedures, which are used for most other products.
3. Develop a regulatory strategy
Once the appropriate regulatory pathway has been determined, you should develop a regulatory strategy that outlines the steps necessary to obtain marketing authorisation.
This may include pre-submission meetings with regulatory authorities, the preparation of a clinical development plan and the development of a comprehensive dossier that includes data from pre-clinical and clinical studies.
4. Conduct clinical trials
Clinical studies are an important component of the marketing authorisation process in Europe. You should ensure your clinical trials are designed to meet the requirements of the European regulatory authorities and conducted in accordance with good clinical practice (GCP) guidelines.
5. Submit a marketing authorisation application
Once clinical trials have been completed, you can submit a marketing authorisation application to the appropriate regulatory authority. The application should include a comprehensive dossier that covers data from pre-clinical and clinical studies, as well as a summary of the benefit-risk profile of the product.
6. Respond to regulatory feedback
After the application has been submitted, you should be prepared to respond to any questions or requests for additional information from regulatory authorities. This may require additional data collection or analysis, as well as modifications to the product labelling or other aspects of the application.
The European Medicines Agency’s new fees for regulatory submissions
Are you concerned about the European Medicines Agency’s (EMA) new fees for regulatory submissions?
As of 1 January 2025, the EMA — the regulatory authority responsible for granting marketing authorisation for drugs in the EU — implemented the EU Regulation 2024/568 on fees for regulatory submissions. This change resulted in a significant increase in some of the fees payable to the European Medicines Agency for scientific assessment of a medicinal product for the application of a marketing authorisation, variation or authorised product.
TMC Commercial provides flexible, full-service drug commercialisation services in the EU and UK — from preparing for submission to post-authorisation — giving you the confidence and opportunity to build your own commercial presence without needing to out-license to a partner.
We also have the specialist expertise to act as your marketing authorisation holder (MAH), either as a temporary bridge or long-term solution.
As an established EU/EEA-based MAH with SME status, we can be your EU/EEA representative, ensuring compliance with all local regulations whilst securing substantial discounts on EMA fees.
By taking on all the legal and regulatory accountability, we can ensure your product is manufactured, marketed and distributed according to the terms and conditions laid out in the marketing authorisation. We make sure, on your behalf, that the product always meets the quality, safety and efficacy standards as approved by the regulatory authorities — helping you bring your products to market efficiently and cost-effectively.
Find out more about TMC Commercial to see how we can save you thousands on your EMA marketing authorisation application and help you gain EU market access quickly and confidently.