EU officials discuss advice pathways, return to office at Convergence

LONG BEACH, CA – Andrea Laslop, head of the scientific office at the Austrian Medicines and Medical Devices Agency (AGES), said that seeking scientific advice from regulators on innovative products is a “well-defined and established process” and that such advice can be requested on any issue related to developing these products.

Laslop made these remarks during the Europe Health Authority Forum at RAPS Convergence 2024.

The panel also featured Sabine Haubenreisser principal scientific administrator at the European Medicines Agency’s (EMA) stakeholders and communication division, Anabela Marcal, an EMA liaison official to the US Food and Drug Administration (FDA), and Caroline Pothet, head of advanced therapies and hematological diseases at EMA.

Laslop explained the three different avenues available to sponsors for seeking advice. These include the EMA Innovation Task Force (ITF), which is meant for sponsors who are seeking advice on products she described as “gamechangers.” These meetings are free of charge and are characterized by “early informal dialogue” with regulators on scientific, legal, and regulatory issues related to their products.

The meetings are characterized by their “brainstorming” style and are meant to cover areas without existing guidance. The aim of these meetings is to prepare for formal regulatory interactions; they are also intended to support the classification of borderline products.

Another pathway is the EU Innovation Network, which provides collaborative regulatory support for medicine developers at the national and the European level. The network aims to facilitate the development of innovative medicines and technologies for drug development by addressing gaps in early regulatory support. It is also meant to provide a platform to share best practices and to strengthen engagement between regulators and innovators. The network is comprised of representatives from the National Competent Authorities and the EMA Innovation Task Force.

EMA’s Priority Medicines (PRIME) scheme also supports medicines of major public health interest and allows expedited scientific advice and various opportunities for interaction with regulators. This pathway is available for medicines that address an unmet medical need and promise a major therapeutic advantage over existing products. The scheme also enables accelerated assessment of these products.

EMA back to in-person meetings

The regulators were asked to discuss EMA’s recent relocation to Amsterdam – which began just before the COVID-19 pandemic erupted – and whether they have encountered any operational or logistical challenges in the move from their long-time headquarters in London.

Haubenreisser said that the move, in addition to the pandemic, prompted the agency to “put things on hold,” though EMA was able to “make sure our core business kept going.”

She added that EMA personnel are shifting back to the office from working remotely. “Our colleagues are in the office a few days a week. People are now there … We now have face-to-face meetings.”

The panelists were also asked to address why EMA and FDA sometimes reach different conclusions about whether to approve the same product, even though there is a move towards greater collaboration between the agencies.

Laslop said that one reason is that EMA officials are “more conservative” than their FDA counterparts and are less likely to approve a product based on surrogate endpoints, whereas FDA has greater leeway to approve or grant accelerated approval to products based on surrogate endpoints.

EU officials discuss advice pathways, return to office at Convergence

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