Pharmaceutical regulation

The life sciences sector encompasses companies in the fields of pharmaceuticals, biotechnology and medical technology that focus on the research, development and commercialisation of a wide range of products that have a medical application. Such products include pharmaceuticals (ie everything from over-the-counter painkillers to advanced therapies for treating diseases such as cancer or HIV), medical devices (eg plasters, syringes, heart stents, pacemakers, etc) and diagnostics. This subtopic provides an overview of pharmaceutical regulation in the EU.

In the EU, a large amount of the regulation originates from directives or regulations and is supplemented by guidance issued by the European Commission and by the European Medicines Agency (EMA), the decentralised agency of the EU responsible for the scientific evaluation, supervision and safety monitoring of medicines.

Regulation of medicinal products

Article 1(2) of Directive 2001/83/EC, the Pharmaceutical Code defines a medicinal product as a substance that is either:

•
presented as preventing or treating disease, or
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used to correct or modify a physiological function by pharmacological, immunological or metabolic action, or to make a medical diagnosis

Practice Note: Introduction to the regulation of medicinal products—EU provides an

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