How To Register A New Medicine In The Uk

Once a new drug has completed clinical trials, it needs to pass through two stages before information technology is made available on the NHS:

Licensing

The licence (or marketing authorization) for a new drug for multiple sclerosis is granted past a regulatory authority. The regulatory authority reviews the clinical research to check that the drug is constructive, safe and meets manufacturing quality standards. If they are satisfied, a marketing potency or licence is issued. This allows the product to be sold by the licence holder in the regions covered by the regulatory authority.

From January 1st, 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) carries out licensing for new medicines in England, Scotland and Wales.

In Northern Ireland, new medicines are licensed by the European Commission following recommendations from the European Medicines Agency (EMA).

MHRA pages on Gov.britain
European Medicines Agency (EMA) website

NHS appraisement

Once a new medicine has been licensed, it needs to exist appraised by the bodies that decide whether it is a cost effective handling to provide on the NHS. The NHS is legally obliged to fund medicines recommended by these bodies. The reverse also holds truthful - if a new drug is not canonical, then local health authorities are not required to provide funding for information technology.

The bodies that appraise new drugs are:

England - National Institute for Health & Care Excellence (Prissy)
Wales - NICE / All Wales Medicines Strategy Group (AWMSG)
Scotland - Scottish Medicines Consortium (SMC)
Northern Ireland - Department of Wellness (DoH)

England: National Found for Wellness & Care Excellence (NICE)

Nice was established in 1999 to reduce variation in access to care and treatment beyond the NHS in England and Wales. Its role has since been expanded to include the promotion of skilful wellness and ill health prevention and social intendance services.

Dainty has three main roles:

Technology appraisals - guidance on the apply of new and existing medicines and treatments. These appraisals decide whether it is cost effective for the NHS to make licensed treatments available. The MS Trust takes an active role in Prissy consultations.
Clinical guidelines - guidance on treatment and care of people with specific diseases and conditions. The most contempo version of the guidelines for MS were published in October 2014.
Interventional procedures - guidance on whether procedures used for diagnosis or treatment, such equally surgery or x-rays, are safe plenty and piece of work well enough for routine use.
Overnice website
National Clinical Guidelines For the Management of Multiple Sclerosis in Master and Secondary Care

Wales: Overnice / All Wales Medicines Strategy Grouping (AWMSG)

AWMSG advises the Welsh Regime to ensure that effective treatments are available to people in Wales. Guidance from NICE usually applies to Wales. If NICE are not due to assess a medication within 12 months of it getting a licence, AWMSG may run their own appraisal.

AWMSG can recommend to the Welsh Government that the NHS in Wales takes an alternative approach to Squeamish guidance. This occurred with their conclusion about Sativex, a drug used to care for spasticity in MS simply not canonical past Dainty. In 2014 AWMSG approved Sativex for use by the NHS in Wales.

All Wales Medicines Strategy Group (AWMSG) website

Scotland: Scottish Medicines Consortium (SMC)

SMC issues guidance on treatments for use by the NHS in Scotland. A separate body, the Scottish Intercollegiate Guidelines Network (SIGN), produces clinical guidelines on areas of healthcare. Both bodies fall under Healthcare Improvement Scotland. Under its pervious proper name (NHS Quality Improvement Scotland) this organisation published national standards of care for neurological weather in Scotland in Oct 2009.

Scottish Medicines Consortium (SMC) website
Scottish Intercollegiate Guidelines Network (SIGN) website
Clinical Standards for Neurological Health Services - Healthcare Improvement Scotland

Northern Ireland: Department of Health (DoH)

Nice guidance is generally accepted in the NHS in Northern Ireland once information technology has been checked by the DoH for any policy and financial consequences.

Department of Health website

Questions about MS?

Call 0800 032 38 39

Electronic mail ask@mstrust.org.uk

Open Monday to Friday, 9am - 5pm.

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