Draft rare disease therapies regulatory framework
Open consultation on the draft regulatory framework for rare disease therapies. The MHRA is seeking feedback on proposed regulations to facilitate development and approval of treatments for rare diseases.
The mhra is inviting written submissions from manufacturers, sponsors, importers, and other industry stakeholders. Review the draft guidance or proposal at the official source, prepare comments identifying any practical impacts on your operations or products, and submit. Active participation helps ensure the final guidance reflects industry realities and gives your organisation early visibility of upcoming requirements.
View official source ↗