TOPRA: CHMP future discussed at annual meeting

Tuesday 6th December 2011

The future work of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) was discussed at a recent meeting in London.

The annual meeting of The Organisation for Professionals in Regulatory Affairs (TOPRA) took place in the EMA building in Canary Wharf from November 24 – 25.

Discussions included the likely interactions between CHMP and the Pharmacovigilance Risk Assessment Committee (PRAC), and the challenges facing them.

Thirty per cent of the items on the CHMP agenda are expected to go to PRAC, meaning the timing of these interactions could be an issue in the Centralised Procedure, it was suggested.

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, especially regarding packaging.

Parallel assessment of Quality by Design applications has begun, while other key features of the work programme for 2012 include new methodologies to assess benefit/risk balance and monitoring of new working parties and Scientific Advisory Groups (SAGs). 

New projects were summarised, including the Summary of Product Characteristics (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 Optimising over-the-counter (OTC) switch applications.

Recent experiences of patient involvement in the EU regulatory procedures were reviewed, including ongoing CHMP projects. 

Interactions have increased dramatically over the last one-to-two 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 Scientific Advice Working Party (SAWP) consultations, safety communications and conferences and workshops). 

There is now one year of experience of patient involvement in SAGs, with one or two 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. 

The EMA plans to revise its framework on interactions between EMA, patient groups and consumer organisations within the next two years.

Good Clinical Practice (GCP) issues were also discussed, with a suggestion that their impact on benefit/risk needs 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.

An overview of the CHMP International Activities project was also presented – part of EMA's overall International strategy with a target date of Q4 2011. 

Bilateral confidentiality arrangements have increased, alongside collaboration with World Health Organistation (WHO), liaison staff from EMA and the US Food and Drug Administartion (FDA) in work placements at the other Agency, the increase in cluster activities (e.g. Biosimilars) and various ad-hoc interactions. 

Interactions between EMA/FDA and EMA/MHLW/PDMA (Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices) have also 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.

TOPRA

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