Introduction The EMA Good Pharmacovigilance Practices consist of several chapters of the Notice to Applicants that are regularly updated. A new GVP Considerations Chapter (IV) regarding specific considerations for the paediatric population came into effect on 8 November 2018. The Considerations Chapter addressed pharmacovigilance issues that frequently arise with the paediatric population and related pharmacovigilance
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).
On 13 October 2016, the European Medicines Agency (“EMA”) opened for public consultation the Guideline concerning clinical investigation of medicinal products in the paediatric population, which has been revised to include a new addendum (“R1”). The public consultation opened following the approval of this draft guideline by the International Council for Harmonisation of Technical Requirements