Finland as a rapporteur in the centralised marketing authorisation procedure (CP)

The European Medicines Agency (EMA) coordinates the centralised marketing authorisation procedure in the EU.

In the centralised procedure, the EMA appoints a Rapporteur and (if necessary) a Co-Rapporteur for each new marketing authorisation application. For human medicines, the members or alternate members of the EMA’s Committee for Medicinal Products for Human Use (CHMP) or the Committee for Advanced Therapies (CAT) can act as a rapporteur together with their assessment teams. In addition, a rapporteur and a co-rapporteur are nominated from the Pharmacovigilance Risk Assessment Committee (PRAC). Their task is to assess the risk management plan. The goal is to select those assessment teams who have the best expertise and experience on the subject of the marketing authorisation application.

Rapporteurships are applied every month.

EMA sends the list of products requiring rapporteurs appointment to the Committee members and each member of the CHMP/CAT/PRAC and their teams then apply for the desired rapporteurships by submitting an application back to EMA. As a result of this application process, EMA nominates the rapporteurs.

Fimea is actively involved in the EU Regulatory Network taking into account the needs of the Finnish health care system. Fimea especially applies for marketing authorisation rapporteurships related to selected focus areas, which are biological and generic medicinal products. Fimea also applies for rapporteurships that are related to new chemical entities that are significant for public health.

In recent years, Fimea has mainly applied for rapporteurships for biosimilars, advanced therapy medicinal products (cellular and gene therapy, tissue engineering), other biological medicinal products for various therapies as well as generic medicinal products.

Fimea has been proactive in piloting multinational assessment teams (that contain assessors from at least two different EU countries) and creating joint EU policies required in such projects. Fimea has a very positive attitude towards this kind of team work with assessors from different countries. Multinational assessment teams enable small countries to participate in and extend the capacity of the EU Regulatory Network.