The European Medicines Agency (“EMA”) has proposed a new draft guideline document on good pharmacovigilance practices concerning medicinal products used by the paediatric population. The proposed guideline will replace the existing “guideline on the conduct of pharmacovigilance for medicines used by the paediatric population” and be a chapter of the good pharmacovigilance practice guidelines (GVP). Integrated as GVP Chapter, the envisaged guideline will integrate paediatric pharmacovigilance with the structures and processes for pharmacovigilance overall.

According to EMA, the increased development of paediatric medicines and the new pharmacovigilance legislation have direct consequences on the conduct of pharmacovigilance in the paediatric population. In particular, Regulation 1235/2010 and Directive 2010/84/EU, adopted in 2012, introduced several changes particularly relevant for the paediatric population.

The draft guideline establishes the structures and processes for the conduct of pharmacovigilance in the paediatric population and covers all paediatric groups. In particular, the draft guideline:

  • Outlines that adverse reactions in the paediatric population need a specific evaluation, as they may substantially differ from those occurring in the adult population;
  • Highlights the importance of risk management plans for medicinal products with a paediatric indication;
  • Emphasises on the need to manage the individual case safety reports by taking into consideration the aspects specifics to the paediatric population.

The proposed guideline also provides guidance in relation to periodic safety reports, post-authorisation safety studies, signal management and safety communication.

The EMA released the draft guideline for public consultation. Marketing Authorisation applicants and holders, EU Member States and any other interested parties may submit their comments on the document until 13 October 2017. The anticipated date for entry into effect is early 2018.