Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Changes of Pharmacovigilance Requirements within the Scope of Volume 9A and Related EU Guidelines

Dr. Desi W. Soegiarto (Abschlußjahr: 2007)

Language: English

On 25 January 2007, the European Commission published the Volume 9A of the Rules Governing Medicinal Products in the European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use which took effect immediately upon publication. The Volume 9A replaces the up to now valid Volume 9. Whereas the old document applied as well as to medicinal products for human use and veterinary medicinal products, the scope of the Volume 9A is exclusively for human medicinal products. Volume 9B Pharmacovigilance for Medicinal Products for Veterinary Use is not yet available and therefore the version of Volume 9 that was made public in June 2004 remains valid for medicinal products for veterinary use.

The Volume 9A contains rules in a number of areas that are not covered by the Volume 9 and provides greater clarity to old issues for the safety professional to contend with. Several guidelines, e.g. Guideline on Monitoring of Compliance With Pharmacovigilance Regulatory Obligations and Pharmacovigilance Inspections, ICH E2E Guideline Pharmacovigilance Planning (Pvp): Note for Guidance on Planning Pharmacovigilance Activities, Guideline on Risk Management Systems for Medicinal Products for Human Use, and Guideline On the Handling of Direct Healthcare Professional Communications on the Safe and Effective Use of Medicinal Products for Human Use (draft version), have been incorporated into Volume 9A to cover new subjects. Furthermore, Guideline on Conduct of Pharmacovigilance for Medicines Used by the Paediatric Population has been pointed out for reporting of data on use of medicinal products in children. Substantial changes in Volume 9A include new and more detailed rules on the role and responsibilities of Qualified Person Responsible for Pharmacovigilance (QPPV), new responsibilities of Marketing Authorisation Holder towards the QPPV, more clarity on transferring pharmacovigilance tasks to third parties (contractual arrangements), details of Individual Case Safety Report submission, a number of new sections regarding requirements for reporting in special situations, and changes to the reporting timelines for Periodic Safety Update Report submission.

Based on the results of the public consultation of 2006 the European Commission announced on 26 February 2007 its intention to develop a proposal in 2008 for improvements to the pharmacovigilance framework in the European Union (EU). The European Commission pointed out that the current pharmacovigilance EU system is complex, unclear, duplicative and an impediment to the single market in pharmaceuticals, and, therefore, needs rationalisation and strengthening. By simplifying reporting rules and by ensuring that robust safety studies are performed to support rapid EU decision-making, the planned reform will better protect public health and support the safe use of new and innovative medicines.

Pages: 55