EU pilot project ‘Market Launch of Centrally Authorised Medicinal Products’

One commitment in the Pharmaceutical Strategy for Europe highlights the need for fair and equitable access to healthcare for all. This latest pilot program has arisen as the European Commission (EC) aims to deliver on this commitment.

Many marketing authorisation holders (MAHs) that pursue the centralised procedure choose not to market their products in all European Union (EU) countries. Factors that may lead to this include:

  • National pricing and reimbursement policies
  • Population size
  • The organisation of health systems and national administrative procedures (particularly in smaller and less wealthy markets)
  • Operational limits of smaller pharmaceutical companies that may be unable to market a product in all Member States

Since this contradicts the core principle of the centralised procedure (to market medicinal products and make them available to patients and healthcare professionals throughout the EU based on a single marketing authorisation), the pilot project is being initiated to better understand the reasons for this and to develop strategies to solve it accordingly. As such, the stated overall objective is “to improve regulators’ knowledge of the planned marketing of centrally authorised medicinal products (CAPs) and on the reasons behind delayed market launch by engaging with prospective marketing authorisation holders through voluntary sharing of their marketing intentions for specific types of CAPs in the pre-authorisation phase.”

Note that the medicinal products covered in this pilot are orphan and oncology medicines as these relate to the unmet needs in the EU and are of high public health interest.

Marketing intentions of the participating companies will be shared through their completion of a questionnaire in the EU Survey tool. The template of this questionnaire is provided in Annex 1 of the document. For new applications, the information will be collected at the time of its submission whilst for ongoing applications, it will be collected at the time of CHMP opinion. Additionally, a Q&A document on the practical aspects of the project has been released by the EMA to help MAHs participate in the pilot.

Further information in the document pertains to the key questions and their outcome measures for this project.

The pilot will launch on 25 March and will run for 18 months until the end of August 2022.

For more details, click here.