EU Initiative Flags Up Challenging Products For Regulators
Executive Summary
A new EU group is keeping a bird's eye view on new innovative medicinal products being brought before member states’ innovation offices, and has flagged up "emerging challenges" and "interesting cases" identified throughout 2017 that need further discussion at the level of the EU medicines network.
A preliminary list of "emerging challenges" and "interesting cases" that were brought before national EU competent authorities this year by developers of innovative medical products has been compiled by the EU Innovation Network (EU-IN). The list will be examined further to ascertain whether the EU medicines regulatory network is well enough prepared to evaluate these innovative products or requires further training.
The EU-IN was established last year to help EU member states voluntarily coordinate their ongoing efforts to identify and support the development of innovative medicinal products through their respective national-level innovation offices. (Also see "New Network To Boost Coordination On Innovative Drugs Across Europe" - Pink Sheet, 23 Jan, 2017.) It is particularly aimed at assisting small and medium-sized enterprises, hospitals and academia.
"One of the most important goals of the EU-IN is to see what gets landed on the tables [of national-level innovation offices], and whether we have the proper competence to answer the questions [posed by these innovative products], and whether these products highlight the need for training [the regulators]," said Esa Heinonen, director of Assessment of Medicinal Products at the Finnish Medicines Agency, Fimea.
Based on products brought before national-level innovation offices in 2017, the EU-IN has already compiled "quite a long list of interesting cases," Heinonen said at a conference organized jointly by the EU Heads of Medicines Agencies (HMA) and The Organisation for Professionals in Regulatory Affairs (TOPRA) in Tallinn, Estonia, on Dec. 1.
Heinonen explained that next year, there are "plans to have a more detailed discussion on some of the selected topics." The discussion will proceed depending on whether the developers of these innovative products agree to their products being examined within the EU-IN and provide additional supporting data.
Nanomedicine and novel manufacturing strategies, such as 3D bioprinting, have been flagged as potential challenges.
Among other topics, nanomedicine and novel manufacturing strategies, such as 3D bioprinting, were flagged up as emerging areas that can pose challenges for regulators, said Heinonen, who chairs the EU-IN along with the European Medicines Agency's Marisa Papaluca.
The EU-IN is a joint initiative of the EMA and the HMA, and it has grown in strength since it became functional earlier this year. As of October this year, the EU-IN had 23 members, up from 17 in January. The plan is to bring more member states within its fold next year.
Heinonen explained that all national-level innovation offices are organized differently. While some operate as virtual groups within the national drug regulatory agency, others are established as separate units. Most of their clients are SMEs, research foundations, consortia and academia, to whom they offer informal advice on a wide range of topics, such as manufacturing processes, GMP, import/export issues, antimicrobials, biostatistics, how to prepare for scientific advice meetings, pharmacovigilance, and interactions with health technology assessment bodies/payers.
The EU-IN is also interested to see how the innovations move forward, and with this purpose in mind it is planning to launch a pilot next year to "track a company's journey through the national and EU regulatory pathway" after it makes an "initial contact" with a national-level innovation office, the Finnish regulator explained.
The pilot, Heinonen said, will be undertaken when concrete cases moving through the EMA's PRIME scheme or other pathways are identified. One of the key aims of the EU-IN is to improve the EU medicines network's capability to help product developers bring their innovations forward from the national to the EU level.
From the editors of Scrip Regulatory Affairs.