The European Medicines Agency (EMA) has implemented a new section to its guidelines on good pharmacovigilance practices (EU-GVP), named “Product- or population-specific considerations II: Biological medicinal products”. Good pharmacovigilance practices are a set of procedures intended to make sure the strength of the system of safety monitoring. The new chapter provides supervision on how to better check and control the safety of biological medicines to optimize the secure and efficient use of these products in Europe.
Biological medicines hold one or more active substances made by or resulting from a biological source, such as blood or plasma. Some of them may be already present in the human body and examples include proteins like insulin and growth hormone. The dynamic substances of biological medicines are larger and more composite than those of non-biological medicines. Only living organisms are able to reproduce such complication. Their density as well as the way they are produced may result in a degree of inconsistency in molecules of the same active substance, particularly in different batches of the medicine.
Therefore the direction seem to support those accountable for monitoring these medicines by:
- highlighting detailed issues and challenges for the pharmacovigilance of biological medicines, e.g. in relation to inconsistency of the active gist or tractability of products;
- providing proposals on how to deal with these specificities and challenges;
- Delineation the roles and responsibilities of the various actors.
The GVP guidance comes into force on 16 August 2016.
Date: 15/08/2016