EMA: How to better apply the paediatric legislation to boost development of medicines for children


How to better apply the paediatric legislation to boost development of medicines for children

EMA and European Commission invite stakeholders to register for joint workshop and support development of an action plan

The European Medicines Agency (EMA) is inviting expressions of interest in a workshop organised together with the European Commission on 20 March 2018 to identify and discuss potential improvements to the implementation of the European Union’s (EU) regulatory framework specific for paediatric medicines, the Paediatric Regulation.

The workshop, which will be held at EMA’s premises in Canary Wharf, London, is a crucial step for the development of a concrete action plan to address challenges identified with medicine development for children in Europe.

The Paediatric Regulation came into force in the European Union (EU) in 2007. In 2017, the European CommissionExternal link icon published a ten-year report on the implementation of the regulationExternal link icon which showed an increase in medicines for children in many therapeutic areas during this time, most notably in rheumatology and infectious diseases. However, it also revealed, for example, that little progress had been made in diseases that only affect children or where the disease shows biological differences between adults and children, particularly some rare diseases. The report has identified areas for concrete actions to address the identified shortcomings. Based on these conclusions, the Commission, EMA and its Paediatric Committee (PDCO) committed to develop a detailed action plan to foster the development of medicines for children in Europe. Feedback from stakeholders at the workshop will contribute to the development of this plan.

A broad range of stakeholders, including patients/carers, academia, healthcare professionals, and industry are invited to the workshop to explore opportunities regarding identification of paediatric needs, timely completion of paediatric investigation plans (PIPs) and improvements in the handling of applications for PIPs. Representatives from national competent authorities, EU institutions and other stakeholders will also attend.

Completed forms for expression of interest from patients, academia and healthcare professionals to attend the workshop should be sent to pmeworkshops@ema.europa.eu by 14 February 2018. Industry representatives will be invited through the registered associations.

Places are limited and will be allocated to ensure a fair representation of all stakeholder groups and organisations.

The workshop will be held from 09:30 to 17:30 UK time. The draft programme of the workshop is available.

A report of the workshop, the action plan and presentations from the workshop will be published on the EMA website.

A live broadcast of the workshop will be available.

This article was originally posted on the EMA website