A session on the forthcoming Paediatrics Regulation, held at the TOPRA and EMEA joint meeting on 7th and 8th December, provided timely debate with publication of the regulation due before the end of the year. In an extensive question and answer session, concerns were raised among attendees with regard to the delay of regulations. However the delegates were appreciative of the preparatory planning work on this issue undertaken by the EMEA, led by Agnes St. Raymond.
Commenting on the importance of this session TOPRA President Axel Wenzel said, ‘Every regulatory affairs professional needs to understand the implications of this new regulation and the process around waivers and Paediatric Investigation Plans (PIPs). We appreciated the EMEA’s insight and eagerly await the publication of the regulation. Furthermore, we hope that our next meeting in Brussels in January will create similarly productive debate’.
This next meeting on Paediatrics Medicines is well-timed, following research undertaken by TOPRA highlighting the lack of knowledge throughout industry towards the forthcoming regulation. The results of the research found that only 21.1% of industry is fully aware of the impact that the new Paediatric Regulation will have on their planned Marketing Authorisation Applications (MAAs). Moreover 30.3% is not at all aware of the opportunities from the new regulation for their existing MAs, with almost half of respondents (47.8%) only partially aware.
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