About this Research Topic
Before the Paediatric Regulation came into effect in 2007, many medicines authorised in Europe were not studied adequately or authorised in children, causing difficulties for prescribers and pharmacists and for the patients and their carers. The Regulation includes the requirement for medicine developers for a paediatric investigation plan (PIP) approved by the EMA Paediatric Committee (PDCO). Learnings from the last 17 years with the Regulation will now be translated into the revision of the pharmaceutical legislation. FDA and EMA have for many years had a paediatric cluster cooperation to support global paediatric plans, with several other countries also involved in the cluster. Worldwide, an increasing number of countries have introduced paediatric provisions in their legislation. This Research Topic will explore the development in regulatory requirements for a paediatric plan in Europe and wordwide.
This Research Topic should address the development in regulatory requirements for a paediatric plan in Europe and wordwide. This would include descriptions of advances in specific disciplines needed for a paediatric investigation plan, e.g., paediatric formulations, juvenile animal studies, paediatric clinical trials, and paediatric extrapolation.
Furthermore, the regulatory advances in paediatric drug development in Europe and worldwide should be addressed. This would optimally include publications on the revision of the EU paediatric legislation, on advances in paediatric legislation, guidelines and policies worldwide, on European and global paediatric research networks, and on global collaboration on paediatric investigation plans. Industry initiatives and viewpoints on this aspects would also be welcomed.
- Advances in specific areas included in a paediatric investigation plan, e.g., paediatric formulations, juvenile animal studies, paediatric clinical trials, paediatric extrapolation.
- The voice of children, young people, and families in PIPs and paediatric drug development
- Regulatory developments in paediatric investigation plans, e.g. new guidelines and policies.
- News on global collaboration on paediatric investigation plans.
- European and global paediatric research networks - global interoperability.
- Industry initiatives and viewpoints on these aspects.
- The revision of the paediatric legislation in Europe.
- Updates on paediatric legislation and paediatric provisions worldwide.
Any type of manuscripts would be of interest, scientific research papers and in particular review articles.
This Research Topic should address the development in regulatory requirements for a paediatric plan in Europe and wordwide. This would include descriptions of advances in specific disciplines needed for a paediatric investigation plan, e.g., paediatric formulations, juvenile animal studies, paediatric clinical trials, and paediatric extrapolation.
Furthermore, the regulatory advances in paediatric drug development in Europe and worldwide should be addressed. This would optimally include publications on the revision of the EU paediatric legislation, on advances in paediatric legislation, guidelines and policies worldwide, on European and global paediatric research networks, and on global collaboration on paediatric investigation plans. Industry initiatives and viewpoints on this aspects would also be welcomed.
- Advances in specific areas included in a paediatric investigation plan, e.g., paediatric formulations, juvenile animal studies, paediatric clinical trials, paediatric extrapolation.
- The voice of children, young people, and families in PIPs and paediatric drug development
- Regulatory developments in paediatric investigation plans, e.g. new guidelines and policies.
- News on global collaboration on paediatric investigation plans.
- European and global paediatric research networks - global interoperability.
- Industry initiatives and viewpoints on these aspects.
- The revision of the paediatric legislation in Europe.
- Updates on paediatric legislation and paediatric provisions worldwide.
Any type of manuscripts would be of interest, scientific research papers and in particular review articles.
Keywords: Paediatric Investigation Plan (PIP), Pediatric study plan (PSP), Proposed Pediatric Study Request (PPSR), Paediatric Regulation, Global paediatric drug development, Paediatric Research Networks
Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.
