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MHRA mulls allowing physicians to prescribe drugs unlicensed drugs

27-Aug-2012

The MHRA wants industry feedback on proposals to make drugs available before they are licensed.

In the plan , which was issued for consultation last month, the UK regulator argues that while its oversight of medicines is necessary for a patient safety perspective, the duration of the review process may be creating unnecessary delays.

The government's regulatory response may be imperfect because some medicines may be unnecessarily denied earlier access to markets even though there is enough information early on to judge that the medical benefits justify the risks. 

If such medicines can be sold at cost effective prices, then UK society would benefit from earlier access to these medicines.

The idea is not to accelerate approvals, but instead give doctors the ability to prescribe drugs still involved in later phase clinical trials to patients before they are approved on the basis that the patients understand and assume some of the risk of using the unlicensed treatment.

Those interested are asked to submit comments to the MHRA by October 5 (earlyaccess@mhra.gsi.gov.uk ).

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