Paediatric medicinal product

A significant proportion of the medicinal products prescribed to children have not yet been (adequately) researched in children. The efficacy and risks of their use in children therefore require more thorough documentation. The MEB attaches great importance to obtaining appropriate data on medicinal products for children. The development of new knowledge, as well as additional information about the use of medicinal products in children, will contribute to improved treatment.

The MEB has a good working relationship with prominent paediatricians/pharmacists in the Netherlands in the field of pharmacotherapy in children, including the Dutch Knowledge Centre for Paediatric Pharmacotherapy NKFK and various research groups.

Paediatric Committee

On 26 January 2007, the Regulation on medicinal products for paediatric use was published and an EMA committee was established, the Paediatric Committee (PDCO). This committee plays a key role in monitoring authorisation studies for paediatric medicinal products.

Currently, the marketing authorisation application for a new medicinal product must also include the outcomes of research performed on the basis of a so-called PIP (Paediatric Investigation Plan). This PIP must be approved by the PDCO. The PDCO can also grant deferment for research in children or decide that such research is not needed (e.g., because the medicinal product is intended for diseases that do not occur in children). As an incentive for paediatric medicines research, patents for medicinal products (in effect the Supplementary Protection Certificate = SPC or additional patent protection certificate) is extended by 6 months.

The option of marketing a special paediatric medicinal product (Paediatric Use Marketing Authorisation - PUMA) is created for existing medicinal products. A special protective mechanism applies for these products: even if the paediatric medicinal product is a line extension of an existing medicinal product, a new protective period for the dossier is nonetheless created.

Paediatric Worksharing procedures

Articles 45 and 46 of the Regulation on medicinal products for paediatric use outline two types of worksharing procedures. Article 45 of the Regulation stipulates that marketing authorisation holders must submit the outcomes of all trials with their medicines in children to the authorities before 26 January 2008. All marketing authorisation holders have now complied, even if no paediatric indication is authorised for their product. The objective of this regulation article is to have all data which had not been submitted previously, available and evaluate them in a worksharing procedure. Following the worksharing procedure, a public assessment report is published and paediatric information in SmPCs and package leaflets of products is harmonised where possible. The CMDh coordinates this worksharing procedure. Harmonisation often proves difficult as the products did not undergo prior harmonisation.

Regulation article 46 stipulates that marketing authorisation holders must submit all paediatric medicine trials to the authorities within 6 months following completion of the trial. The objective of this regulation article is to evaluate all new studies in a worksharing procedure also, enabling direct harmonised inclusion of this new information in the SmPCs and package leaflets of all relevant products in the EU. This worksharing procedure is also coordinated by de CMDh.

Paediatric Medicines Experts

Both the European Commission and the MEB attach great importance to:

  • The development of new medicinal products for children
  • Continued research into the use of existing medicinal products in children
  • The development of new pharmaceutical forms of existing medicinal products for children
  • Remaining focused on medical (research) practice while realising its tasks

With the adoption of the Regulation on medicinal products for paediatric use, and in that connection the establishment of the Paediatric Committee in Europe, the MEB has expanded and consolidated its expertise in the field of paediatric medicine. To this end, collaboration has been sought with a number of prominent paediatricians/pharmacists and research groups in the Netherlands in the field of pharmacotherapy in children.

Openbare beoordelingsrapporten kindergeneesmiddelen

The website of the 'Heads of Medicines Agencies' (the joint website for all national competent authorities) has an overview of all public assessment reports (PARs) in the area of paediatric medicinal products.

These reports are obtained via the EU work sharing system. EU work sharing is a cooperative process in which EU Member States share the activities involved in assessing paediatric data.