Regulatory routes for cancer treatment in Britain - Come early

MHRA and Health Technology Appraisal (HTA) Advisory Support

 

Advice from the Medicines Regulator: MHRA offers a variety of services including their innovation office. Early engagement is encouraged and scientific advice can be sought at any point in drug development and can be revisited throughout the development programme. Additional participants to the sponsors are welcomed to the advice meetings such as patient representatives or trial site staff. This may be particularly helpful for programmes involving novel or personalised trial designs. 

 

Advice and support from HTA: NICE offers Scientific Advice and support typically before the onset of phase 3 trials but can be sought at all stages of health technology development.  NICE also provides the Office for Market Access (OMA) to life sciences industry partners. Here multiple stakeholders, identified during preparatory discussions, are invited to engage in a structured and extended engagement meeting with the sponsor to discuss issues such as service delivery and commercial options. While sponsors can engage at any stage of product development to gain insights to inform the development of their ongoing market access strategy, OMA engagement offers maximum benefit when undertaken early in the market access and reimbursement process.  

 

Joint Advice: Joint advice is also available from MHRA and NICE. Sponsors will be invited to a face-to-face meeting with NICE, MHRA and a panel of experts at which there is an opportunity to discuss the clinical study design that can satisfy both regulatory and NICE requirements. The outcome is a single report with a joint NICE and MHRA advice summary, exploring health technology assessment, scientific and regulatory issues.