Proposals for Reform in OMP and Paediatric Regulations
"Review and provide input on proposals for reforming Orphan Medicinal Products (OMP) and Paediatric Regulations. Explore limitations, key topics, and submission timeline. Participate in the consultation process to enhance development frameworks and treatments for rare diseases and children."
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Presentation Transcript
PUBLIC CONSULTATION OMP & PAED REGULATIONS Simone Boselli 3 June 2020
Objectives Allowing you to provide input to our feedback Present our proposals for reform Facilitate your direct input to the consultation 2
Limitations of the current OMP development framework Focused on disease areas where treatments already exist Not equally focused on adults and children Benefitting only a few disease areas Concentrated on the least rare diseases 3
Key topics covered in the questionnaire Barriers to the development of treatments for rare diseases and children? Impact of COVID1 & lessons learnt Suggested approaches to incentives Improvements in the development of medicines for the paediatric population Additional measures Role of repurposing 5
Process moving forward End of June deadline for providing input HTA Task Force (1st week of July) CNA call today DITA Task force (2nd week of June) TAG (last week of June) Second / Third week of July submission & publication of position 7
