Results from clinical trials are submitted to regulatory agencies to obtain a licence prior to it being made available to patients. Licensing is needed to confirm the quality, efficacy and safety of a medicine. Whilst no medicine is risk-free, a licence demonstrates that all the proper checks have been carried out and the potential benefits of the medicine are believed to outweigh the risks.
In the UK, licences are granted by The Medicines and Healthcare Products Regulatory Agency (MHRA).
In order for medicines to be made available to UK patients through the NHS, it is necessary to gain market access and reimbursement after licensing. This is achieved through health technology assessment (HTA) through reviewing clinical effectiveness and cost effectiveness of a medicine. In the UK, examples of HTA agencies are the National Institute for Health and Care Excellence (NICE), All Wales Medicines Strategy Group (AWMSG) and the Scottish Medicines Consortium (SMC).
The UK is home to Pfizer’s
Global Regulatory Affairs, where licensing submissions for over 175 markets across the globe are managed.
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