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Case Studies

Accelerated MAA

An international-based client requested advice and support for its plans to enter the UK market with one of its lead products. The opportunity was time critical due to known generic competition and supply issue with the branded proprietary product. The product was a critical care medicine for which it was proposed there was a strong clinical justification to meet an unmet need in the UK.

Accelerated assessment was crucial to the success of the project.

Parallel requests made for legal entity and supply chain set up for the UK market.

The Solution

Supplier landscaping identified suitable partners, some of whom required process licence (import licence) applications and GMP audit to meet legal expectations.

A short term solution was implemented to supply the UK with the product as a “Specials” unlicensed medicine, whilst the UK MAA was under assessment. This allowed the client company to establish its presence in the market and with the clinicians.

Scientific advice and close liaison with MHRA led to acceptance of the fast track MAA assessment request.

Immediate resource requirement for a PM and 2 senior regulatory personnel. Additional support and partners were provided by Regulink for PV, PL user testing, scientific services and non-clinical and clinical experts for the MAA itself and for the client in the long term to meet its obligations as MAH.

The Outcome

Once MHRA committed to accelerated assessment, MAA was granted in < 1 year, including clock stops.

“Specials” importation for a period pre-MA grant.

Critical cancer-care patients are now able to receive a guaranteed treatment of a safe and effective medicine, made possible through effective collaboration with the Competent Authority.

We want to hear from you.

Do you have projects in the pipeline that may qualify for expanded access/ compassionate use, or EAMS (UK), or MAA fast-tracking? Is Scientific Advice likely to be required?

Can you access experienced support immediately and flexibly?

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