News/Events

Thursday 16 December 2010 White paper: New law strengthens EU pharmacovigilance system!


Member state ministers are under  huge political and social pressure to ensure the safety of medicinal products by improving preventive measures and by keeping a constant watch on the risk/benefit analysis of these products. Pharmacovigilance programmes need to be adequately supported to achieve these objectives. This is taking place in times of a difficult economic climate and governmental indebtedness which is the reason why our healthcare system must be protected.
The following elements are therefore particularly important in the current environment:

 

  • The future guideline for the Development Safety Update Report (DSUR) is currently in ICH step 4 and should come into effect at the end of 2011. This guideline implies an exhaustive reporting, not only on observed safety concerns during clinical trials, but also cross analysis with non-clinical data and, more challenging, an ongoing re-evaluation of the benefit-risk balance of medicinal products during clinical trials.

  • The Eudravigilance database will be the single portal of receipt of reporting of PV cases. Its goal is to promote the electronic communication of the cases (ICH E2B) and to allow transparent information towards EU citizens on the safety profiles of  marketed drugs . This includes a summary of the risk management plans and the capacity for any citizen to report on what he/she believes as an abnormal reaction to a medicinal product.

  • The  PV system, while still required to be set up and detailed for inspections by each company, shall be described in less detail to the authorities. Only key elements will need to be submitted.

  • The scope of the Periodic Safety Update Report will also change to present a risk/benefit analysis of the product instead of a list of individual case reports which are already submitted through Eudravigilance.

  • A new Pharmaceutical Risk Assessment Committee (PRAC) at the EMA will play a decisive role. It will continuously analyse and prioritise new risk signals and changes to the risk/benefit balance of medicinal products. Its recommendations could lead to a new appraisal of marketing authorisations.

  • Post Marketing Safety Studies and even Post Marketing Efficacy Studies may be imposed on the Marketing authorization holder by the EMA.

 

Thus there are a lot of criteria which have to be taken into account as early as possible. Before the new legislation comes into effect, you need to be well prepared for the new challenges. The following aspects need to be planned for:

 

  • Information needs to be controlled: external and internal, clinical and non clinical as well as information relating to safety and efficacy•    Information needs to be presented to authorities in new ways

 

  • Information needs to be organized for confidentiality so as to be able to provide summaries to the public, competitors, scientific publications and as a basis and for discussion on appraisals of the risk/benefit analysis of medicinal products.

 

ProductLife  predicted these developments beforehand and has extensive experience and expertise in preparing and assisting you in impleting these changes and/or transitions by providing process, business and consulting services adapted to your particular needs .
ProductLife is on a well known territory when it comes to the areas of assistance and the daily support of companies.

 

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