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EMA update

 

The European Medicines Agency (EMA) has published the first summaries for the public of the Paediatric Committee's (PDCO) evaluations of paediatric investigation plan (PIP) and waiver applications. The summaries published today relate to PIPs for a cell-based therapy for the treatment of non-traumatic osteonecrosis, a new medicine for the treatment of atopic dermatitis and a waiver for a medicine for eye diseases.

From now on, the Agency will publish such summaries for each PDCO evaluation of an application for a PIP or a full waiver. The summaries describe the proposal from the applicant for the development of their medicine in children, the PDCO's conclusion on the potential use of the medicine in the paediatric population, the plan agreed between the committee and the applicant at the completion of the procedure (including any partial waivers or deferrals) and the next steps.

This new type of document increases the amount of public-friendly information published by the EMA on its assessments of medicines that are still under development, before they are authorised for use in the European Union. These summaries complement the public-friendly information already made available by the Agency, including public summaries of European public assessment reports, risk management plans and opinions on orphan designation.

Since the Paediatric Regulation came into force in the EU in 2007, pharmaceutical companies have had a legal obligation to develop all new medicines for children as well as for adults in line with an agreed PIP, unless they obtain an exemption (waiver).

The PDCO reviews all applications for PIPs and waivers and issues an opinion on the clinical studies, pharmaceutical forms and tests that must be performed in children. These studies may be deferred, for example if the PDCO considers that experience in adults is needed before paediatric clinical trials are conducted. Additionally, the PDCO may grant a full or partial waiver from the obligation to develop a medicine in paediatric populations when the condition concerned does not exist in children, when the medicine is not likely to offer any benefit for children, or when it is unsafe to use it in children. This helps to avoid unnecessary paediatric studies.