​​​​​​​New study examined development needs of the regulatory competence of European medicines agencies

Fimea participates in the EU4H IncreaseNET project co-financed by the European Commission, which is aimed at enhancing cooperation and networking between the competent authorities in the pharmaceutical sector and identifying the most critical learning needs of the pharmaceutical authorities.

The aim of the project is also to increase understanding of what expertise the medicines agencies are lacking, what obstacles hinder education and training and how the learning needs vary in different regulatory areas. The collected information can be used to better support the development of the authorities’ competence, for example, by producing and piloting innovative training models and strengthening recruitment strategies. 

Shortcomings have been identified, but the learning needs have not been completely understood

The results of the surveying carried out in the project have now been published in the Clinical Pharmacology & Therapeutics journal.

The EU Medicines Regulatory Network plays a key role in ensuring the safety and efficacy of medicines for human use.

The rapid scientific and technological development has challenged the network’s capabilities in competence and capacity. It has also created development gaps that threaten the decision-making related to regulations. Although the shortcomings have been identified, a comprehensive understanding of the network’s specific learning needs has been incomplete.

The interviews with stakeholders and the extensive survey carried out in the study enabled the identification of six priority areas for competence development:

• advanced therapy medicinal products
• biological active substances
• clinical drug trials
• modelling and simulation
• pharmacokinetics and
• statistics.

The results also highlighted systemic obstacles, such as uneven distribution of expertise, a high workload and challenges in recruitment. In addition, the study revealed methodological inconsistencies in the assessment of the network’s learning needs.

The results of the study support the development of more agile and flexible regulatory competence. It is made possible by providing information for the design of targeted and pedagogically sensible training strategies. The development of competence and capacity increases the quality of drug evaluations. It also speeds up patients’ access to innovative treatments in Europe.