UK MHRA Aims To Cast Early Access Scheme In New Light
Agency Wants To Make EAMS More Attractive To Sponsors Of Innovative Medicines
The UK’s Early Access to Medicines Scheme continues to provide important flexibility, but companies also now have the option of a new ambitious pathway launched this year for accelerating time to market for innovative medicines.
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The MHRA has drawn up measures to improve regulatory certainty around the UK’s early patient access scheme while reducing regulatory burden in certain areas of its operation.
More political support from the National Health Service and health ministers is needed to ensure the UK’s future as a desirable launch market.
The UK regulator, the MHRA, has published guidance on its new integrated pathway for innovative drug approvals, which it says is intended to bring together partners including health technology assessment agencies, health care bodies and patient organizations to offer “sustained collaboration” with drug developers.