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UK drugs regulator opens doors to early access applications at cost of 33,000


The UK's drugs regulator said on Monday it has opened its doors to the first applications for "promising innovation" and subsequent "early access" to the market, at a cost of around 33,000.

The Medicines and Healthcare Products Regulatory Agency (MHRA) said in a statement it was ready to assess initial clinical data that shows a product might be suitable for a 'promising innovation medicine' (PIM) designation.


PIM designated products are those which might be candidates for early access, based on subsequent positive Phase II data. Products need to demonstrate an early indication of efficacy for conditions where there are no suitable alternative licensed treatments.


Once clinical data is available, companies will then submit a second application for early access and if successful, will be able to start treating patients before Phase III trials and the licensing procedure are completed.


MHRA chief executive Dr Ian Hudson said: "This is a significant step forward for the earlier availability of medicines in the UK and we look forward to receiving applications to the scheme."


Unlike in the U.S., the scheme will be paid for by industry and rates are the same for all companies regardless of their size or scope, from small research organisations to big pharma.


The cost of an initial PIM application is £4,027. Once a product has PIM status, it does not expire or need to be renewed - unlike the early access opinions.


A subsequent assessment of clinical data for an early access scientific opinion is £29,000 per indication. The opinion will be shared with healthcare professionals as guidance on how to prescribe the treatments, in the absence of any licence. However, it applies for one year only.


After a year, companies must renew early access scientific opinions at a cost of £14,500 - unless they receive a successful marketing authorisation.


For companies to submit data for a second indication for an experimental product the fee is £9,232 and subsequent renewal fees are £4,616.


The early access scheme means some products could reach patients almost 10 years earlier than via the existing process, however only if companies continue to pay the annual renewal fees.


While welcomed overall by industry the BioIndustry Association (BIA), which represents UK medical research-stage companies, has criticised the scheme for not being publicly funded as in the U.S.


When details of the scheme were announced last month, a spokesperson told APM: "Without the funding there is not much point in it."


The BIA has said it will help companies as much as possible to benefit from the scheme.



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