News

Last weeks round-up; 13 – 17 January 2020

published 20 Jan 2020

THE ART OF DOING CLINICAL REGULATORY WELL

With over 8000 clinical applications every year, the landscape of clinical regulatory is becoming increasingly challenging to navigate. These additional challenges have pushed Sponsors into trying to achieve the same objective with the same or reduced financial and human resources. For this to be possible, project management and involvement of experienced CRO and regulatory consultants are vital to the smooth and effective running of clinical trial applications, with a focus on forward planning and anticipating issues that may be raised during the assessment process. For more information, please see the following link: https://lnkd.in/dQKjmDW

HPRA UPDATE: GUIDE TO LABELS AND LEAFLETS OF HUMAN MEDICINES

The HPRA have published an update to their Guide to Labels and Leaflets of Human Medicines at the beginning of January 2020. Amendments have been made to the information on leaflets and package labelling which does not require formal assessment and do not need to be notified until the next regulatory opportunity. More specifically, the HPRA does not require a formal notification when administrative information from an EU member state or the UK in the blue box is either added, deleted or changed, as long as no other changes are made, and it does not impact on the livery of font size of the packaging. The bulk of the update relates to multilingual packaging requirements.

The HPRA encourages the use of multilingual packaging, in the case of supply shortages on the Irish market, provided the readability is not compromised, following the principles of the CMDh Best Practice Guide on Multilingual packaging. New considerations are given to packaging which includes third country information (such as UK details), joint names and small immediate packaging unit requirements. For further information, please see the following link: http://bit.ly/2R73KAa