EMA Boosts Transparency On Maintaining Orphan Status At Time Of Approval
Executive Summary
New orphan maintenance assessment reports are expected to increase transparency around the European Medicines Agency's decision-making process on whether an orphan-designated drug continues to qualify as an orphan once it gets on to the market.
You may also be interested in...
Orphan Drugs Study Compares EMA's Significant Benefit With HTA's Relative Effectiveness Assessments
A first of its kind study is underway to look at how the significant benefit assessment of orphan products by the European Medicines Agency compares with relative effectiveness assessments by health technology assessment bodies.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EMA Hopes New Requirement Will Make Companies Stick To Their Filing Plans
An additional form that marketing authorization applicants must now complete during the pre-submission stage emphasizes the importance of companies providing accurate information on their intended submission date.