UK Speeds Up Access to Medicine

The UK Government’s Department of Health has recently announced an Early Access to Medicine scheme with the goal of accelerating drug accessibility to patients with limited therapeutic options. The Medicines and Healthcare Products Regulatory Agency (MHRA) will oversee the scheme, which will require that the drugs be demonstrated as safe and beneficial to patients but not that the drug be fully approved. The Early Access to Medicine scheme is a two-step process, in which, if the drug is shown to be safe and effective in humans, the MHRA can issue a “promising innovation medicine” designation. This will then be followed by a full scientific review of the existing clinical data to assess the risks and benefits of the drug. Hopefully, this program will also be beneficial to ALS patients in the UK seeking access to novel drugs.

The UK Government’s Department of Health has recently announced an Early Access to Medicine scheme with the goal of accelerating drug accessibility to patients with limited therapeutic options. The Medicines and Healthcare Products Regulatory Agency (MHRA) will oversee the scheme, which will require that the drugs be demonstrated as safe and beneficial to patients but not that the drug be fully approved. The Early Access to Medicine scheme is a two-step process, in which, if the drug is shown to be safe and effective in humans, the MHRA can issue a “promising innovation medicine” designation. This will then be followed by a full scientific review of the existing clinical data to assess the risks and benefits of the drug. Hopefully, this program will also be beneficial to ALS patients in the UK seeking access to novel drugs.

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