Masterstudiengang "Drug Regulatory Affairs"


Impact of the new Pharmacovigilance legislation on national level

Sylvia Streit (Abschlußjahr: 2012)

The rapid increase of medicinal products on the market provides a great benefit for patients, but is also associated with an enhanced risk of adverse side effects. The term Pharmacovigilance (PV) comprises all aspects associated with the risk-benefit ratio of medicinal products after their authorisation including detection, assessment and prevention of adverse effects. In this thesis, the new Regulation (EC) No 1235/2010 and the Directive 2010/84/EC upon its implementation into the draft 16th amendment of the German Drug Law are being analysed with regard to their impact on Pharmacovigilance on national level.

One of the major changes the new PV legislation intends to cause is increased transparency with regard to PV-related topics. To this end, the Eudravigilance database will become the central site in Europe to collect all PV data for medicinal products. The preparation of publicly accessible lists of closely monitored medicines and the constant adaptation of their package leaflets will help to enhance transparency for patients. Additionally, the responsibilities and tasks of Member States, Marketing Authorisation Holders and the Agency will be defined more clearly. In order to avoid multiple assessments of reports on adverse drug reactions (ADRs), reporting procedures will be simplified by submitting these reports directly to the Eudravigilance database. Moreover, patients will be encouraged to report encountered side effects themselves to the national authorities. In future, overdosing- and medication error-related as well as non-serious adverse effects shall be notified as well.

Furthermore, the new legislation is going to provide a legal basis for a proactive risk management system for each new medicinal product which in its contents shall be proportional to the drugs potential risk. As PSURs will focus more on the analysis of the risk-benefit ratios rather than represent a sequence of individual case reports, they shall also reflect the potential risk associated with the medicinal product in a proportional manner. As a consequence, routine reporting of PSURs will no longer be necessary and PSUR submissions, in general, are going to be facilitated.

Through the establishment of the new committee PRAC, the EU decision-making procedures will be improved as harmonised decisions will be made and resources will be used more efficiently. Moreover, one of the major PRACs responsibilities will be to take over the assessment of PSURs which is supposed to allow a faster update of the product information.
For MAHs, the most relevant change currently will be the requirement to provide the Agency with key information on all authorised and registered medicinal products in line with Article 57(2) of the new Regulation. Additionally, the legal right of competent authorities to request post-authorisation safety and efficacy studies also represents an important change for MAHs as well as the new labelling requirements.

In conclusion, the amended legislation - once it came into force - will have significant impact on PV in Germany, as all concerned parties will be affected.