Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

2 years Variation Regulation: A retrospective critical assessment from the industrial perspective ***

Angelika Kamp (Abschlußjahr: 2012)

On 01st of January 2009, Commission Regulation (EC) No 1234/2008 entered into force, replacing the former Commission Regulations 1084/2003 and 1085/2003. The new Variation Regulation should design the regulatory framework "simpler, clearer and more flexible, without compromising public and animal health and reduce administrative burden". (Commission Regulation (EC) 1234/2008)

In order to achieve this objection, several innovations were introduced, such as "Do and tell", Annual Report, Worksharing, Grouping and Type IB by default.
Since 01st of January 2010, the new Variation Regulation is applicable for all MAs registered via CP, MRP or the Decentralised Procedure (DCP).

The retrospective assessment of the new Variation Regulation two and half years after its applicability showed that the newly introduced tools have a great impact on the work in Regulatory Affairs Departments.

With the help of a survey on Commission Regulation (EC) No. 1234/2008, including 23 participants from 18 different companies, the general assessment of the Variation Regulation and the impact of its innovations on the practical work was estimated.

The offered options of the revised Variation Regulation were adopted by the pharmaceutical industry to a varying extent, depending on their usability in practice. Next to the advantages provided by the new tools, such as an increased flexibility, decreased workload and downgraded variation types, new challenges are linked to the usage of the diverse tools, such as the need for intensive tracking and strategic planning or the increased complexity of the dossier maintenance.

The last two years showed that Commission Regulation (EC) 1234/2008 influences the number of variations, the distribution per variation type and the total variation costs.

In sum, the options offered by the new variation regulation present the Regulatory Affairs Departments with several advantages and a new set of challenges.

It is concluded that the introduction of Commission Regulation (EC) 1234/2008 is regarded as an improvement by the pharmaceutical industry, but that there are still areas for improvement.

A short outlook indicates that, especially for Germany, the implementation of the Variation Regulation at a national level will change the variation system to a great extent and entail major challenges.

Pages: 57, Annexes: 21 pages