European SME Week – early dialogue with the EMA is key to success

26 November 2013

“Companies that request and follow scientific advice provided by the European Medicines Agency (EMA) have a 90% success rate at the stage of marketing-authorisation application compared with a 30% success rate for companies that do not comply* with scientific advice,” explains Spiros Vamvakas, Head of Scientific Advice at the Agency.

Scientific advice is one of many tools available to micro, small and medium-sized companies (SMEs) to support them in the development of their medicines and increase their chance of success at the marketing-authorisation stage. These tools promote interaction and dialogue with the Agency from the very early stages of medicine development and throughout the medicine's lifecycle.

Support to medicine development is a priority for the Agency. This is reflected in the Agency's new structure, which aims to consolidate its support to development through the creation of its Human Medicines Research and Development Support Division.

An Tools available to micro-, small- and medium-sized enterprises (SMEs) during the development of their medicines is available.

Tools available to micro-, small- and medium-sized enterprises (SMEs)

Focus on some tools for early dialogue

• Scientific advice: Companies can request scientific advice from the Agency at any stage of development of a medicine. Scientific advice helps companies ensure that they perform the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorisation application (MAA). Parallel scientific advice with health-technology assessment (HTA) bodies or with the United States Food and Drug Administration is also available. SMEs that are registered with the Agency benefit from a 90% fee reduction on scientific-advice procedures. In 2012-2013, 28% of SMEs sought scientific advice for human medicines. Contact point: [e-mail].
• Innovation Task Force (ITF): this platform allows early dialogue with applicants to identify scientific, legal and regulatory issues related to emerging therapies and technologies and borderline medicines. ITF is often the first contact point with the Agency. The service is free for all companies. Six SMEs in 2012 and four in 2013 were involved in ITF meetings. Contact point: [e-mail].
• Qualification of new methodologies for development: to support companies in the research and development of new medicines, the Agency's Committee for Medicinal Products for Human Use (CHMP) issues opinions on the acceptability of using novel methodologies, such as an imaging method, a modelling methodology or a biomarker, in their clinical development. The qualification opinion can be provided prospectively on the planned strategy for developing a novel methodology or be based on an assessment of data submitted by the applicant. In 2012-2013, six SMEs requested such qualifications. Contact point: [e-mail].
• Certification of advanced-therapy medicinal products (ATMPs): This service is provided to SMEs only. The certification procedure is an opportunity for SMEs to get an assessment of the quality and non-clinical data they have generated in the development of their ATMP. The aim is to identify any potential issues early in the development so that these can be addressed prior to the submission of an MAA. Three ATMP certifications have been completed so far. Contact point: [e-mail].

 

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**Correction: On 27 January 2014 at 12:00, the statement 'Companies that request and follow scientific advice provided by the European Medicines Agency (EMA) have a 90% success rate at the stage of marketing-authorisation application compared with a 30% success rate for companies that do not request scientific advice' was corrected to ' Companies that request and follow scientific advice provided by the European Medicines Agency (EMA) have a 90% success rate at the stage of marketing-authorisation application compared with a 30% success rate for companies that do not comply with scientific advice'.