Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Status quo 2015 - Post-Authorisation Pharmacovigilance for Human and Veterinary Medicinal Products in Germany and Europe

Sabine Günther-Commerscheidt (Abschlußjahr: 2015)

Summary
Language: English
Marketing authorisation holders and applicants, service providers, organisations, competent authorities as well as the European Medicines Agency (EMA) have gained experience with the new pharmacovigilance legislation for human medicinal products for three years now. All these parties were faced with new challenges. Until 2012 the regulations on veterinary and human pharmacovigilance were largely the same. With the new pharmaceutical package that came into effect in July 2012, a clear cut was made between veterinary and human pharmacovigilance. Contrary to initial expectations, work load and manpower requirements on the human site increased to fulfil obligations. Currently, great flexibility is required from marketing authorisation holders of human medicinal products, as unforeseeable work due to e. g. referral procedures, changes in the EURD list or changes in Individual Case Safety Reports (ICSRs) reporting modalities can arise at any time. The willingness of pharmaceutical companies to invest in new or existing marketing authorisations in the EU decreases, when costs and efforts are not covered by revenue. The new approach improved transparency, whereof patients, health professionals and pharmaceutical stakeholders are supposed to benefit. Important projects which still need to be worked on are the EudraVigilance database and Guideline on Good Pharmacovigilance Practices (GVP) Modules XI, XII and XIV. It remains to be seen, when the database provides all necessary functionalities and when the GVP guideline will be completed with the outstanding modules.
The so called pharmaceutical package was intended to harmonise, rationalise and strengthen pharmacovigilance in human medicine in the EU. It appears that the aim of rationalisation was not achieved in the first years of implementation, although a few steps forward were made. Thus, updates of the Pharmacovigilance System Master File (PSMF) are now facilitated as competent authorities accept a summary of the pharmacovigilance system instead of full description. Progress was made towards the goal of strengthening pharmacovigilance by 1) establishment of Pharmacovigilance Risk Assessment Committee (PRAC), 2) enhancement of the power of competent authorities to impose conditions to marketing authorisations, 3) granting patient organisations access to committees, e.g. PRAC, as well as improving communication of pharmacovigilance issues to the public and 4) extending the scope of responsibilities and duties of marketing authorisation holders. Little harmonisation was reached between EU member states, as for example Directive 2001/83/EC and Directive 2010/84/EU were transposed into national law of member states, but in partly divergent ways.
Recognising important problems linked to the current legislation on veterinary medicinal products, the European Commission decided to revise Directive 2001/82/EC and related legislation. A draft proposal for a new regulation on veterinary medicinal products was published in September 2014. The proposal includes major changes in pharmacovigilance, e.g. for ICSRs no distinction will be made between serious and non-serious events and all these reports will be submitted within 30 days. Marketing authorisation holders may designate several QPPVs each with limited competence for specific products of the portfolio. The Detailed Description of the Pharmacovigilance System, DDPS, will be aligned to the PSMF and will relate to the product and not to the marketing authorisation holder as before. Submission of a PSMF summary is not yet planned, but from the industry’s and competent authorities’ point of view highly recommended. Periodic Safety Update Reports are no longer required. Signal detection via EMA database will be the major tool for identification of safety issues. It remains to be seen, which pharmacovigilance innovations will be implemented and whether this regulation will lead to new revisions of the pharmacovigilance legislation for human medicinal products.
Pages: 70