Roundtable debate: MEP welcomes dialogue on new legislation


TOPRA organised a roundtable discussion where regulatory affairs professionals had the opportunity to meet Marina Yannakoudakis, MEP. The event took place on 10 January 2013 at the Royal Society.

Marina is an MEP for the London region in the UK and sits on the ENVI committee, the Environment, Public Health and Food Safety committee within the European Parliament.

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Human medicines highlights - Issue 47 - December 2012

The December 2012 issue of the European Medicines Agency's newsletter 'Human medicines highlights' is now available.

All issues of the newsletter are available on the Agency's website.

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CAT Monthly Report for December 2012

The monthly report of the Committee for Advanced Therapies (CAT) has been published in the European Medicines Agency's website.

See all the CAT Monthly Reports

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MHRA publishes medicines reclassification guidance

mhra_website_logo.jpgFollowing the announcement in the Chancellor’s Autumn Statement, the Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new, streamlined procedure to speed the process of moving medicines from prescription-only to over-the-counter medicines.

Read more on the MHRA website

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Industry raises some concerns over PRACticalities of pharmacovigilance hearings

The infrastructure for holding public hearings under the EU pharmacovigilance legislation’s Urgent Union Procedure is not yet in place, but industry is nonetheless concerned about how this will work in practice. At TOPRA’s Annual European Medicines Agency Review of the Year and Outlook for 2013, companies pressed EMA officials for more information on the procedure during an update on PRAC (Pharmacovigilance Risk Assessment Committee) activities.

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