Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.

Paediatric Regulatory Network (PRN)

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What is the WHO Paediatric Regulatory Network?

The WHO Paediatric Regulatory Network is a global paediatric working network supporting the availability of quality medical products for children through facilitation of communication, collaboration, training, and regulatory harmonization between regulators and other stakeholders across the development, registration and pharmacovigilance of paediatric medical products.

Mission of the WHO Paediatric Regulatory Network

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To support the availability of quality medicines for children through facilitation of communication, collaboration, training, and regulatory harmonization across the development, registration and pharmacovigilance of paediatric medicines.

Objectives of the PRN

The objectives of the PRN are as follows:

  1. Provide a forum for discussion between NRAs to build awareness around regulatory considerations for paediatric medical products and facilitate the collaboration, information sharing, information dissemination, discussion and work towards consensus on regulatory ʹstandardsʹ for quality paediatric medical products.
  2. Support the NRAs in strengthening their regulatory capacity for paediatric medical products by increasing regulatory cooperation, information sharing and training.
  3. Promote the collection of evidence and data in children by encouraging conduct of appropriate paediatric clinical trials. This may include establishing links with existing national or international networks focusing on global paediatric CTs, relevant statistical methods, and on scientific and ethical review of clinical trials for the development of paediatric medical products. Promote the collection of evidence and data in children.
  4. Facilitate access to appropriate paediatric medical products through encouraging the development and enabling in-country availability of appropriate paediatric medical products, with attention to identifying the special needs of children in low- and middle-income countries and other paediatric populations. Promote reliance and recognition activities to facilitate registration of paediatric medicines. Act as facilitator for the regulatory steps to allow in-country paediatric medical products’ availability in case of health emergencies.
  5. Promote and strengthen paediatric pharmacovigilance and complement, where needed, existing mechanisms for information sharing.
  6. Identify the need and, where needed, suggests the development of evidence-based recommendations and guidelines on relevant aspects of medical products for children, including for example dosage forms and excipients.
  7. Promote networking and collaboration with other entities to leverage the expertise of for example patients and families, networks, NGOs, ethics groups, industry associations, academics, and public private platforms involved in research and development of paediatric medical products, authorization procedures, pharmacovigilance, and capacity building, and to foster interaction with developers, health‐care professionals and consumers.
  8. Advocate for a patient centric development and encourage working with patients and carer representatives for the development of paediatric medicines.
  9. Use appropriate fora and opportunities to promote and communicate on paediatric regulatory matters with policy makers.
  10. Encourage relevant expansion of membership of the network and active engagement and consider as much as possible a representation by regional economic communities (RECs) or other countries grouping, where possible, to maximize the number of countries being represented.

 

Background information

Previous documents

The Paediatric medicines Regulatory Network was initially created in February 2010 in response to a recommendation from the 2008 International Conference on Drug Regulatory Authorities and as part of the Bill and Melinda Gates Foundation “Better Medicines for Children” Project as a global paediatric working group to offer a platform for discussion on paediatric regulatory considerations for National Regulatory Agencies (NRAs).  The Paediatric Regulatory Network was re-activated at the Initiation Task Force Meeting held on 5-6 December 2019 in Geneva with strong engagement from National Regulatory Authorities, development partners and other stakeholders.

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