Guidelines on engaging with regulators
Many IMI projects are developing tools and methods with a potential regulatory impact, such as tests and measures to evaluate medicines safety or efficacy, or alternative clinical trial designs. For this reason, we encourage all projects to seek regulatory engagement as early as possible. Early engagement with regulators is critical, and this is emphasised by regulators themselves, for example in the conclusions of the regulatory science summits organised by IMI in collaboration with the EMA and FDA.
IMI has developed guidance for projects to raise awareness of the various opportunities to interact with regulators in the framework of research on regulatory sciences with a potential impact on public health. Through documents and webinars, we provide a high-level overview of the existing services offered by regulators. Note that these documents do not replace official procedures and requirements to validate or obtain formal advice from the relevant regulatory agencies.
- In December 2017, IMI held a webinar covering: EMA activities in support of EU-funded research projects for medicines innovation; the EMA’s Innovation Task Force; EMA’s qualification of novel methodologies; EMA support to SMEs; opportunities for engagement with the FDA to support drug development
Download the presentations | Watch the webinar online
- This guidance document (August 2015), developed jointly by EFPIA and IMI, summarises the services offered by regulators and is intended for use by researchers who wish to have a better understanding of these opportunities.
Links to relevant pages on the EMA and FDA websites
- European Medicines Agency (EMA) page on qualification of novel methodologies for medicine development
- Qualification of novel methodologies for drug development: guidance to applicants (EMA/CHMP/SAWP/72894/2008)
- European Medicines Agency process for engaging in external regulatory sciences and process improvement research activities for public and animal health
- U.S. Food & Drug Administration (FDA) page on Drug Development Tools Qualification Programs