The Path to Progress: Regulatory Affairs and Medical Affairs Spotlight
After Clinical Trials, the next stage of The Path to Progress journey is Regulatory Affairs and Medical Affairs.
Once a drug has gone through the necessary clinical trials, before a medicine can be placed on the market and become available to patients in the UK and Ireland, it must obtain marketing authorisation and a license.
At Bristol Myers Squibb there are two departments who are responsible for making this happen: Regulatory Affairs and Medical Affairs.
About Regulatory Affairs
Spanning across a large proportion of the drug development process, Regulatory Affairs within the UK & Ireland ensures that regulatory protocols, or rules, are adhered to at each stage of a medicine’s development. These can refer to rules on testing or analysing the clinical trial data, medicine labelling, packaging design and much more.
Regulatory Affairs use the clinical trial research to apply for marketing authorisation. This is then submitted to the country regulator, such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK or the Health Products Regulatory Authority (HPRA) in Ireland. Once authorised, a medicine will be given a licence for use in that country. Regulatory Affairs is responsible for maintaining this licence so the medicine can continue to be made available for patients.
Once marketing authorisation has been granted, Regulatory Affairs help to maintain a medicine’s licence to allow a continuous supply. This includes submitting new variations of the licence to regulatory bodies when information on the licence changes, to ensure that it is medically accurate and compliant throughout a medicine’s lifecycle. Regulatory Affairs manage the implementation of the MHRA and HPRA decisions for national products, spanning from product labelling and artwork, to formulating strategy and guiding product development processes.
About Medical Affairs
Medical Affairs also play a pivotal role in helping to achieve marketing authorisation for a medicine, effectively linking science and commercial activity. As well as communicating scientific and clinical information to the medical community through various channels, and supporting with research, Medical Affairs ensure that patient health and wellbeing are at the forefront of product decisions. This involves providing a clinical interpretation of the scientific and clinical trial data that can be understood by regulators and marketers, so that an informed decision can be made regarding marketing authorisation and subsequent activities throughout a medicine’s lifecycle.
A key responsibility of Medical Affairs is ensuring that critical, accurate information is relayed to all relevant stakeholders across the drug development journey. This includes reviewing materials to ensure that everything is compliant with the Association of the British Pharmaceutical Industry (ABPI) and the Irish Pharmaceutical Healthcare Association (IPHA) codes of conduct, which the UK and Irish pharmaceutical industries are required to operate within.
Regulatory Affairs and Medical Affairs at Bristol Myers Squibb in the UK & Ireland
Kruti Shah, Associate Director and Regulatory Lead in Oncology, and Waise Haider, Disease Area Specialist in Dermatology and Rheumatology, work as part of the Regulatory Affairs and Medical Affairs teams at Bristol Myers Squibb, and are based at our UK Head Office, in Uxbridge.
Watch the Regulatory Affairs and Medical Affairs Spotlight video below, to learn more about their day-to-day roles and how they play a critical role in bringing more treatment options to patients who need them.