3.1 The European network in medicines regulation – National Competent Authorities (NCAs)

The European network in medicines regulation – National Competent Authorities (NCAs)

At the level of concrete and detailed guidance to industry, the EU works together in a close network. National Medicines Agencies (National Competent Authorities, NCAs) work together with each other and with the EMA.

The 27 member states (MS) have established an informal network between the Heads of the Medicines Agencies (HMA) of the individual MS. This network meets on a regular basis with EMA participation. In the HMA group, the overall structure of the collaboration between participants in the network is overseen.

NCAs participate in regulation development at all levels. Formally, the ministry of health of a MS participates in council working parties on directives and regulations. However, in most MS staff from NCAs participates intensely in the work. In many cases, they will even accompany the ministry at meetings of council working parties or will be on secondment to the commission for extended periods (two to four years).

The EMA coordinates the development of new and revised scientific EU guidelines. The work takes place in EMA working groups. Typically, the NCA of each MS may appoint a member for each working party. Thus, representatives from the NCAs primarily do the concrete work on scientific guidelines.

Regulatory guidelines are most often developed by the Commission in the Notice to Applicants (NtA) Working Party. Again, NCA delegates participate substantially in the process.