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The European Medicines Agency (EMA) has announced two initiatives to improve medicine provision in Europe.
The EMA will hold a workshop jointly with the European Commission on paediatric medicine to find out how better to apply paediatric legislation to boost development of medicines for children.
The workshop — to be held on 20 March 2018 at EMA’s offices in Canary Wharf, London — will identify and discuss potential improvements to implementing the Paediatric Regulation, the European Union’s (EU) regulatory framework specific for paediatric medicines.
In 2017, the European Commission’s 10-year report on the implementation of the regulation revealed little progress had been made in diseases that only affect children or where the disease shows biological differences between adults and children. The report identified actions to address the regulation’s shortcomings.
Based on these conclusions, the Commission, EMA and its Paediatric Committee (PDCO) said they were “committed to develop a detailed action plan to foster the development of medicines for children in Europe”, and that “feedback from stakeholders at the workshop will contribute to the development of this plan”.
The EMA has also updated procedural advice on the evaluation of advanced therapy medicinal products (ATMPs).
It said the aim was to streamline some procedural aspects, strengthen collaboration between EMA’s scientific committees, and address specific needs of ATMP developers in the evaluation procedure for initial marketing authorisations.
The EMA said it hoped this will help developers of these medicines – often small and medium-sized enterprises (SMEs) or academic spin-offs – navigate the regulatory process in the EU.
Updates to procedural advice include streamlining the list of questions and outstanding issues discussed by the EMA’s scientific committees assessing ATMPs, and allowing developers more time to respond to questions.
The EMA said the updated advice was “an important step forward in the support of developers as it addresses their need for more clarity in the evaluation procedures for these innovative medicines”.
Completed forms for expression of interest from patients, academics and healthcare professionals to attend the paediatric medicine workshop should be sent to pmeworkshops@ema.europa.eu by 14 February 2018.
