TeamDrive
RUS

European Commission released action plan on paediatrics

10 October 2018

GMP News

The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have published a joint action plan to support the development of medicines for children in Europe.

The action plan addresses challenges identified by the European Commission’s ten-year report on the implementation of the Paediatric Legislation. It also takes into account the ideas on how to better apply the Paediatric Regulation to boost the development of medicines for children collected during the multi-stakeholder workshop organised by EMA and the European Commission in March 2018.

The actions in the plan are clustered around five key areas:

  • identifying paediatric medical needs;
  • strengthening cooperation between decision makers;
  • ensuring timely completion of paediatric investigation plans (PIPs);
  • improving the handling of PIP applications;
  • increasing transparency around paediatric medicines.

It is expected that the implementation of these actions will increase the efficiency of paediatric regulatory processes in the current legal framework and boost the availability of medicines for children.

The plan was originally intended to be completed within a two-year timeframe. However, due to the impact of Brexit and the Agency’s relocation to the Netherlands, some actions are not expected to be completed by the end of 2020, as specified in the plan. The plan will be updated over time as necessary, depending on prioritisation and availability of resources.

The Paediatric Regulation came into force in the EU in 2007 to encourage manufacturers to research and develop medicines for children’s specific therapeutic needs by using a system of rewards and obliging developers to specifically plan the development of their medicine for children (e.g. by integrating it into the development for adults) and submit a corresponding PIP. PIPs are scientifically reviewed and agreed by the EMA’s Paediatric Committee (PDCO), which was also introduced by the same legislation.


Previous publication Next publication

Media Center

  • 19 October 2018

    FDA Publishes Guidance on the Rare Disease Treatments

    FDA published draft guidance on October 15, 2018 to assist sponsors developing treatments for rare diseases plan for pre-investigational new drug application (pre-IND) meetings with FDA. In the guidance, the agency describes topics that should be considered in early drug development and pre-IND meetings.

  • 18 October 2018

    Russia emerges as frontrunner in global fight against tuberculosis

    Russia has turned out to be the world’s most successful tuberculosis fighter, Russian Health Minister Veronika Skvortsova stated  during the interview with the Rossiya-24 channel. "We are the global leader according to the pace in solving this issue," she noted, adding, "all countries acknowledge Russia’s foremost role here."

  • 17 October 2018

    Scientists developed new tool for open exchange of biomaterials

    A new easy-to-use legal tool that enables open exchange of biological materials was launched. The OpenMTA is a Material Transfer Agreement (MTA) designed to support openness, sharing and innovation in global biotechnology. Material Transfer Agreements (MTAs) provide the legal frameworks within which research organisations define terms and conditions for sharing their materials – everything from DNA molecules to plant seeds to patient samples.

  • 16 October 2018

    The First FDA-approved Digital Pill — What It Means for Pharma

    Last year, the U.S. Food and Drug Administration (FDA) approved what is perhaps the boldest use of digital technology in healthcare: a pill that is integrated with an ingestible sensor that captures information about whether the patient has complied with her medication regimen. A patient ingests the pill and it sends the data to a patch worn on her torso, which adds various physiologic measures. From there the information is wirelessly sent to a mobile phone app, allowing both the patient and her physician to track how the patient is using and responding to her medication.

Read more