Medical assessors in regulatory agencies
All clinical trials are governed by regulations designed to ensure that a drug is effective and safe before either being granted market authorisation or approved for the next stage of research. Medical assessors in regulatory agencies, such as the MHRA and the EMA, work to ensure that clinical trials are carried out to the highest ethical and safety standards and in the best interests of the patient. Regulatory agencies input into the design of trials and the eventual use of a medicine at every stage in the development process.
To ensure a high-quality service, medical assessors scrutinise clinical study reports and periodic safety reports, and maintain up-to-date summaries of product characteristics. They also work in inspectorate divisions of the agency, and are involved in good practice inspections of companies. Inspections occur either when a breach of Good Clinical Practice (GCP) is reported, when a company applies for marketing authorisation, or on an ad-hoc, or routine basis under a risk-based compliance programme. Regulatory agencies, such as MHRA, have direct interaction (through inspection and ensuring legal/regulatory compliance) with the medical services described in other sections, and with regards to GxPs – eg GCP, Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).