How can SME Accreditation Maximise your Benefits with the EMA?

Navigating the pharmaceutical landscape in the European Union (EU) can be a complex and daunting task, particularly for small and medium-sized enterprises (SMEs). Accreditation with the European Medicines Agency (EMA) is a crucial step for SMEs aiming to bring orphan drugs or innovative medical products to the market. SME accreditation can offer additional benefits to the companies that have orphan designation (OD), when combined, these two frameworks can offer significant advantages to the sponsors. This blog provides an overview of the benefits of EMA SME accreditation for orphan drug and other medicinal product developers, and how the upcoming reforms in EU pharmaceutical legislation impact SMEs, and the incentives and services available to support these businesses.

SME Incentives from the EMA

The EMA offers a variety of incentives designed to support SMEs in their journey to bring new medicines to market:

• Fee reductions and deferrals: SMEs can benefit from reduced fees for various regulatory procedures, including scientific advice, marketing authorisation applications, and inspections. Fee deferrals are also available, allowing SMEs to delay payment until after the completion of specific regulatory milestones. SMEs holding orphan designations (ODs) are eligible for substantial reductions or waivers of regulatory fees as detailed in the table below.

Financial Incentives of SME holders:

MA: marketing authorisation; MAA: marketing authorisation application; OD: orphan designation

• Translation assistance: The EMA provides support to SMEs for translating product information into all official European Union (EU) languages for ODs and initial marketing authorisations.

• Administrative and procedural assistance: The EMA offers administrative assistance to help SMEs with the preparation and submission of regulatory documents. This includes support with the use of electronic submission systems and guidance on regulatory requirements. This can accelerate timelines, lower costs, and improve access to OD.

• Tax credits and research and development (R&D) Incentives: In some EU member states, SME status combined with OD can qualify for additional tax credits or R&D incentives aimed at encouraging innovation in rare disease treatments.

• Access to MedDRA: SMEs can receive fee waivers for subscriptions to the Medical Dictionary for Regulatory Activities (MedDRA), essential for the coding of medical data.

• Contact the SME office for questions about regulations, administrative requirements or procedures by phone or email.

• Request a briefing meeting to…
  • • engage in an early dialogue with a multidisciplinary EMA team
    • discuss a regulatory strategy for a human or veterinary product development
    • find out about available procedures, guidance and incentives

• Receive guidance on clinical data publication

• Stay up to date with SME newsletters

• Participate in training events

• Receive support with looking for academic partners in the paediatric-medicine field

• Certification for ATMPs: The certification procedure for ATMPs is open exclusively to SMEs. It provides a mechanism for companies to receive scientific feedback on quality and non-clinical data generated during the course of development. The certification procedure aims to provide support for companies seeking to attract investors for the development of their product or to license it out.

Impact of EU Pharmaceutical Legislation Reforms on SMEs

The EU pharmaceutical legislation is continuously evolving to enhance the regulatory environment, ensuring that it keeps pace with scientific advancements and the needs of patients. Recent reforms have significant implications for SMEs:

• Streamlined regulatory processes: The introduction of more streamlined procedures for the approval of medicines aims to reduce the time and cost involved in bringing a product to market. This is particularly beneficial for SMEs, which often operate with limited resources.

• Enhanced support for innovation: The reforms emphasise the importance of fostering innovation. This includes providing scientific advice and support to SMEs throughout the development process, ensuring they can navigate regulatory requirements effectively.

• Increased transparency and predictability: The updated legislation aims to increase the transparency of the regulatory process and provide greater predictability. This helps SMEs to better plan their development and commercialisation strategies.

• Simplified procedures for orphan and paediatric medicines: Special provisions have been made to support the development of orphan and paediatric medicines, which often involve high risk and significant investment. These reforms can be particularly advantageous for SMEs focusing on niche markets.

SME Services Provided by DLRC

At DLRC, we provide comprehensive support to SMEs navigating EMA accreditation.

Our services include:

SME holding

If you are a non-EEA-based SME company, through our German affiliate Orphix Consulting GmbH’s SME holding services, you can benefit from all the SME incentives in the EU.

SME application

We offer expert advice on your SME application, helping you understand and comply with EMA requirements. Our team of experienced professionals ensures that the submission is meticulously prepared, and any further enquiries from the EMA are handled with care. We have helped numerous clients to attain SME accreditation.

SME renewal

Our experts are dedicated to assisting you with SME renewal each year to ensure your SME status is active so that you continue to qualify for incentives.

SME transfer

We also provide transfer services for SMEs from different organisations or different affiliates within the same organisation.

Summary

European Medicines Agency (EMA) accreditation is a critical step for small and medium-sized enterprises (SMEs) aiming to bring rare or orphan drugs and innovative medical products to the European market. Understanding the implications of recent European Union (EU) pharmaceutical legislation reforms and leveraging the available incentives can significantly enhance an SMEs chance of success. With our specialised services, we are committed to guiding SMEs through the complex regulatory landscape, ensuring they can focus on what they do best: developing groundbreaking medical solutions.

For more information on how we can support your SME in achieving EMA accreditation, please contact us today at hello@dlrcgroup.com with any questions you may have – our experienced team of SME experts are here to assist you in the advancement of your SME accreditation and will participate in these discussions with you to facilitate your communication with the regulatory agencies.