Written by Nicole Scholz
A high level of protection for human health is a central objective of European Union (EU) public health policy. To guarantee this objective, high standards of quality and safety for medicinal products are essential. Although pharmaceuticals are primarily regulated at the national level by the Member States, there is a large body of EU legislation in the field.
A medicine must be authorised before it can be placed on the market. In the EU regulatory system, there are several routes for obtaining marketing authorisation: either at European level (the centralised procedure) or at national level (the decentralised and mutual-recognition procedures). Under the centralised procedure, EU authorisation is granted by the European Commission via an application to the European Medicines Agency (EMA). The EMA coordinates the assessment of the quality, safety and efficacy of medicinal products. It draws up scientific opinions for the evaluation of such medicines for the EU institutions and the Member States. The EMA also coordinates Member States’ activities in connection with the monitoring of medicines for safety once they have been placed on the market (pharmacovigilance), and manages the internet-based information system created to this effect. In addition, the EMA coordinates Member States’ supervision and inspection of manufacturers.
Two special authorisation procedures exist outside the conventional routes: Article 58 applications (for medicines used exclusively outside the EU) and the procedure for compassionate use. There are specific regulatory rules for ‘orphan medicines’, as well as paediatric, geriatric, advanced-therapy, herbal, homeopathic and non-prescription medicines.
A number of instruments have been put in place to guarantee that a medicinal product fulfils the legal requirements in terms of quality, safety and efficacy. These are the principles of good manufacturing, good distribution, and good pharmacovigilance practices. They are complemented by information for patients and protection against
falsified medicines. With a view to allowing early access to medicines, a new concept – the adaptive pathways approach – has recently taken shape. It is based on existing regulatory procedures such as compassionate use, and involves progressive access to medicines in advance of full authorisation. This could particularly benefit patients who have a medical condition not adequately addressed by an existing therapy.