Current projects

Pharmacovigilance of biologics

Biologics are medicinal products obtained from natural sources such as humans, animals or micro-organisms. Biologics are much larger and more complex than small molecule medicines, as well as that they are more difficult to manufacture. Biologics can sometimes be more sensitive to small alterations in the manufacturing process, which can influence product characteristics and result in batch-to-batch variations. The EU pharmacovigilance legislation specifically calls out the need to report adverse drug reactions (ADRs) for these products by brand name and batch number to ensure that ADRs are accurately ascribed to the correct causative product. However, recent studies have found that only about 20% of ADR reports for biologics contained the batch numbers.

Working within community and hospital settings, the objectives of this new project are to evaluate practices and health information systems for tracking biological product information and the ADR reporting processes in the EU. This project will also be estimating the potential impact of misclassification of products during ADR reporting on safety signals for biologics. 

The project is executed in collaboration with Utrecht University and Exon Consultancy. For the investigation of the practices in the Netherlands, Escher is collaborating with the Royal Dutch Pharmacists Association, the Dutch Association of Hospital Pharmacists and the Netherlands Pharmacovigilance Centre Lareb. The project is supported by an unrestricted research grant of the European Biopharmaceutical Enterprises (EBE).

Improving the EU system for marketing authorisation

Learning from regulatory practice
A data–driven assessment of the regulatory system for marketing authorisation, based around a number of case studies, which aims to identify opportunities for improving the system. Specific cases include: pharmacovigilance & PASSs studies, the conditional marketing authorisation pathway, the decentralised & mutual recognition procedure and paediatric investigation plans. 

Download the latest report

The regulatory system for the marketing authorisation (MA) of medicines has been successful, helping to bring many safe and effective medicines to the market. Various changes to the system over recent years demonstrate the ambition of the EMA and its European network to learn and to adapt to new challenges.

Such changes to different parts of the regulatory system are directed at finding a better way to balance two main goals. First, to ensure timely patient access to medicines that address healthcare needs. Second, to ensure that medicines are marketed only when there is sufficient confidence about a positive benefit-risk balance.
Continuous reflection is therefore needed to assess whether or not regulation is achieving its intended aims, and many potential questions arise. For example, do we know the added value of recent changes? What can we learn from their introduction, and how can we make sure that future changes are implemented in an effective manner? Answering questions of this kind depends on gaining more insight into the use and performance of the regulatory system, via monitoring, analysis and evidence-based assessments. By producing the current report, Escher is seeking to make its own contribution to providing this insight.

Aims
The project has two aims:

• To provide a scientific analysis of topics in a number of key areas in the regulatory system
• To reflect on how the regulatory system can benefit from further research.

Organization and way of working
This is an independent research project carried out by Escher, under the umbrella of TI Pharma, and currently funded by a grant from EFPIA and AESGP. The project is executed by Utrecht University and Exon Consultancy. Additional public and private partners support the project by delivering data and expertise through advisory groups.