CHMP work plans take account of patient involvement, new pharmacovigilance legislation and GCP issues.

The work of the CHMP in 2012 and beyond was discussed at the recent TOPRA/EMA joint meeting

Eric Abadie commented on the likely interactions between CHMP and PRAC and the challenges facing them (e.g. 30% of items on the CHMP agenda are expected to go to PRAC, hence timing of these interactions could be an issue in the Centralised Procedure). On quality, it is believed that the falsified medicines legislation will impact on CHMP as the provision for safety features will have a direct impact on products (packaging). Parallel assessment of Quality by Design applications has begun (1 application to date). Other key features of the work programme include new methodologies to assess benefit/risk balance and monitoring of new working parties and SAGs. New projects were summarised, including the SmPC implementation plan and the new geriatrics expert group. Revision of the pandemic preparedness plan will take place based on experiences with the 2009 pandemic. The CHMP will also be looking at how to improve use of the Centralised Procedure for OTC switch applications.

Isabelle Moulon reviewed recent experiences of patient involvement in the EU regulatory procedures, including ongoing CHMP projects. Interactions have increased dramatically over the last 1- 2 years. Patient groups are now members of all of EMA's main committees (and will be members of the new PRAC) and are involved in many EMA activities (e.g. SAGs, CHMP and SAWP consultations, safety communications and conferences and workshops). There is now 1 year of experience of patient involvement in SAGs, with 1 or 2 patient representatives routinely involved in SAG meetings throughout the year. Both patients and regulators found the experience positive, and a report on this experience is to be presented to CHMP shortly.. EMA plans to revise its framework on interactions between EMA, patient groups and consumer organisations within the next 2 years.

Jens Heisterberg provided some interesting insights on GCP issues whose impact on benefit/risk need to be considered by CHMP. Whilst many GCP issues can be resolved during the approval process, some are more likely to impact on the overall benefit/risk balance.

Emer Cooke provided an overview of the CHMP International Activities project, part of EMA's overall International strategy with a target date of Q4 2011. Dr Cooke highlighted what has been achieved in terms of bilateral confidentiality arrangements, ongoing collaboration with WHO, liaison staff from EMA and FDA in work placements at the other Agency, the increase in cluster activities (a new cluster is Biosimilars) and various ad-hoc interactions. Interactions between EMA/FDA and EMA/MHLW/PDMA have generally been increasing in recent years. Examples of new interactions include the first Quality by Design pilot application and new interactions in the cardiorenal and rheumatoid/pulmonary areas.

London 24 – 25 November 2011 – this meeting is an annual event organised by TOPRA with EMA and was held this year in the EMA building in Canary Wharf.

Notes to Editors

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The Organisation for Professionals in Regulatory Affairs (TOPRA)

TOPRA is the global organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector. Current membership is drawn from over 40 countries and members worldwide are actively involved in delivering the services needed by busy regulatory specialists. Members are drawn from industry, the regulatory agencies and the consultancy community and work in all sectors including medical technologies, biotech, borderline products and pharmaceuticals.

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