European Medicines Agency announces start of process improvement of core business procedures

Press release 18/03/2011

Improvements aim for efficiency gains through better regulation

The European Medicines Agency has today launched a project to improve processes of its core business, as announced in its 'Road map to 2015' in January 2011. The project responds to one of the road map's objectives, namely to ensure a continuous high-quality delivery of the Agency's core business in an increasingly complex regulatory and scientific environment, while making optimal use of available resources.

The programme aims to improve the efficiency of processes in order to support the Agency's capabilities to deliver sustainable results. The programme will initially focus on processes for the authorisation, supervision and maintenance of medicinal products to increase internal efficiency while maintaining quality of opinions and satisfaction of applicants.

While some improvements will result from identification and elimination of internal process complexity, significant improvements in throughput and lead time will require that applications be submitted to the highest possible standard.

As one of the first measures to improve the efficiency of processes, the Agency is providing a pre-notification checklist to help applicants submit complete and correct type IA variation notifications for medicines for human use, with the aim of raising the quality of these applications.

An initial analysis of the process for minor variations of type IA indicated that notifications received by the Agency are often not correct or incomplete, despite post-authorisation guidance provided by the Agency to applicants. This has resulted in unprecedented numbers of requests for supplementary information to improve the quality of submissions and longer timelines from receipt to closure of type IA notification procedures.

The Agency will continue to monitor the future quality of type IA notifications submitted and further measures may be required.

The Agency will continue to keep stakeholders informed, as part of its programme to improve core business processes.

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