U.K. outlines early access program
The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) is asking for public comments on a proposal that would allow early access to unlicensed products for life threatening, chronic, or seriously debilitating conditions without adequate treatment options. MHRA said the program would apply to products with a "positive benefit-risk profile" that have completed Phase III testing. The agency estimates that 1-2 products per year would qualify for the program. MHRA added that in exceptional cases the program may be used for products at an earlier stage of development.
The proposal would allow sponsors to request an MHRA early opinion on an unlicensed product for a fee of L29,000 ($45,000). The opinion will be valid for one year and is renewable for L29,000 per year. Sponsors will not be allowed to advertise the products. Local level NHS organizations will be responsible for deciding whether to fund early access products from existing budgets. ...