Objectives of the PmRN
The objectives of the PmRN are as follows:
- Provide a forum for discussion between NMRAs to build awareness on paediatric medicines regulatory considerations.
- Facilitate the collaboration, discussion and work towards consensus on regulatory 'standards' for paediatric medicines.
- Promote capacity for development of paediatric medicines, including formulations, with attention to identifying the special needs of children in developing countries and other vulnerable paediatric populations.
- Promote appropriate conduct of paediatric clinical trials, including establishing links with existing networks, as well as work on scientific and ethical review of clinical trials for the development of paediatric medicines.
- Strengthen licensing (approval) systems for paediatric medicines by increasing regulatory cooperation, information sharing and training.
- Identify the need for, promote the generation of, and make available, evidence-based recommendations and advice on all aspects of medicines for children, including dosage forms, excipients and delivery devices for medicines.
- Provide a forum for promoting and strengthening paediatric pharmacovigilance, including identifying needs for methodological development and complementing existing information sharing mechanisms.
- Encourage expansion of the membership of the Network to include all NMRAs.
- Collaborate with other networks and NGOs on research and development of paediatric medicines, licensing procedures, pharmacovigilance, and capacity building, and to foster interaction with industry, health-care professionals, patients and consumers.
For the full version of the PmRN Terms of Reference, please see Annex 1 of the Report of the First Meeting of the Paediatric medicines Regulators' Network, February 2010: