European Commission, EMA Pilot Launched to Challenge Centralized Authorization Procedure

BRUSSELS, Belgium – The European Medicines Agency (EMA) and the European Commission (EC) have launched a new pilot program focused on improving regulators’ knowledge of the planned marketing of centrally authorized medicinal products (CAPs) and the reasons behind delayed market launch.

Together, the two bodies will engage with marketing authorization applicants through voluntary sharing of their marketing intentions for specific types of CAPs in the pre-authorization phase.

According to the document, the pilot project will run for a total period of 18 months, from 25 March 2021 to until August 2022, when the results and lessons learned from the pilot project will be published by the European Commission, based on aggregated data and fully respecting the confidentiality principle.

Particularly orphan and oncology products with newly submitted centralized applications, or applications under consideration, are eligible to choose to participate in the pilot. From the starting date, the EMA will invite marketing authorization applicants for orphan medicines and medicines to treat cancer to participate in the pilot project by making a declaration of market launch intentions on a voluntary and confidential basis.

The Commission noted in the release: “It is a particular challenge to the underlying principle of the centralized authorization procedure. This procedure allows marketing authorization holders to market medicinal products and make them available to patients and healthcare professionals throughout the EU based on a single marketing authorization.

“While Member States are mostly concerned by the issue, both the European Commission and the European Medicines Agency (EMA) have an important stake in this discussion due to their role in the marketing authorization process for centrally authorized products and the link to certain provisions in the EU legislation.

“In the Pharmaceutical Strategy, the Commission has committed to initiate a pilot together with the EMA and Member States, with the engagement of future marketing authorization holders, to better understand the root causes of deferred market launches for centrally authorized products. This action is supported by the Human Pharmaceutical Committee.”