Pilot project ‘Market launch of Centrally Authorised Medicinal Products’
The Pharmaceutical Strategy for Europe highlights the importance of patients' access to medicines. Innovative and promising therapies do not always reach the patient and, in the EU, there are still different levels of access to medicines.
It is a particular challenge to the underlying principle of the centralised authorisation procedure. This procedure allows marketing authorisation holders to market medicinal products and make them available to patients and healthcare professionals throughout the EU based on a single marketing authorisation.
While EU countries are mostly concerned with the issue, both the European Commission and the European Medicines Agency (EMA) have an important stake in this discussion due their role in the marketing authorisation process for centrally authorised products and the link to certain provisions in the EU legislation.
In the strategy, the Commission has committed to initiate a pilot with EMA and EU countries, with the participation of future marketing authorisation holders, to better understand the root causes of deferred market launches for centrally authorised products. This action is supported by the Human Pharmaceutical Committee.
The pilot’s overall objective is to improve regulators’ knowledge of
- the planned marketing of centrally authorised medicinal products (CAPs) and
- the reasons behind delayed market launch
The Commission and EMA expect to achieve this by engaging with marketing authorisation applicants through voluntary sharing of their marketing intentions for specific types of CAPs in the pre-authorisation phase. The applicants can also make suggestions on how to improve the situation.
From 25 March 2021, the European Medicines Agency will invite marketing authorisation 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 information collected will be well stored in a secured environment and used for the purpose of the pilot project only.
25 March 2021 to August 2022