In reaction to the shifts in the environment, the regulatory structure for medications is fast altering. The pharmaceutical industry is becoming increasingly globalized, there is an increase in digital technology and internet use, along with the changes in the lifestyle and habits of the patient populations bringing in remarkable shifts in the communities. The rapid use of technology across the globe is also one of the contributors that has impacted on the healthcare sector. It is no wonder that all these rapid changes have influenced and impacted the pharmaceutical environment resulting in inevitable changes in the regulatory environment. Amongst the leaders worldwide, the UK holds a dominant position in influencing the regulatory environment globally and also has paved a path in the world of pharmaceuticals. UK’s (MHRA) Medicines and Healthcare Products Regulatory Agency regulates medicines, products of blood, and medical devices to boost and protect the health of the public. It also promotes innovation by funding scientific study and development. It advances UK health interests and collaborates closely with other organizations to form a single pharmaceuticals network throughout Europe. The MHRA oversees an array of initiatives, including the Innovation Office, which assists innovators in navigating the regulatory procedures in order to advance their goods or technological advances, as well as the Early Access to Medicines Scheme and the simplification of the Clinical Trials Regulations, which both aim to speed up patient access to innovative medications.
The health department, controlling approximately over 14 agencies and partner companies, supervises the MHRA as an executive agency. The agency of MHRA comprises of three centers: the National Institute for Biological Standards and Control (NIBSC), a leader in the standardization and control of biological medicines; the Clinical Practice Research Datalink (CPRD), a data research service that aims to improve public health by using anonymized National Health Service (NHS) clinical data for research; and the regulatory center, which oversees the UK’s medicines, medical devices, and blood components. The agency’s three centers collaborate to safeguard and advance public health.
With the exception of Northern Ireland, the EMA no longer makes regulatory decisions regarding medicinal items in the UK following its exit from the European Union. It is the MHRA that acts as the only independent regulatory body in the UK. The drug’s intricacy, the application data’s standard, the chosen pathways of regulatory, and the efficacy of the process of review are some of the selected variables taken to determine the time taken for a drug’s approval in UK. From the time a medicine is discovered until it is approved, the procedure can take several years on average. For medicines which are complex the overall approval process from the discovery initially to the ultimate approval takes somewhere between eight to fifteen years or more than that. Nonetheless, for a drug to be used for treating a fatal disease or a condition that is life threatening, can be faster approved.