The medicines regulatory environment is evolving rapidly in response to the changing environment. The role of the MHRA is to regulate medicines, medical devices and blood components for transfusion in the UK. The Agency plays a leading role in protecting and improving public health, and supports innovation through scientific research and development. The MHRA is an executive agency, overseen by the Department of Health, which has oversight of some 14 agencies and partner organizations. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development. It works closely with other bodies in a single medicines network across Europe and takes forward UK health priorities. This paper discusses the range of initiatives in the UK and across Europe to support innovation in medicines regulation. The Agency is made up of three centres: 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 purposes; the National Institute for Biological Standards and Control (NIBSC), a global leader in the standardization and control of biological medicines; and the regulatory centre, which performs the UK’s medicines, medical devices and blood components regulatory function, responsible for ensuring their safety, quality and efficacy/performance. The three centres of the Agency work together in synergy to protect and promote public health. The MHRA works very closely with the European Medicines Agency (EMA) and other equivalent bodies throughout the EU in a single medicines network. The MHRA leads a number of initiatives, such as the Innovation Office, which helps innovators to navigate the regulatory processes to progress their products or technologies; and simplification of the Clinical Trials Regulations and the Early Access to Medicines Scheme, to bring innovative medicines to patients faster.
The industries producing pharmaceuticals and medical devices are increasingly global in nature, developing products for global markets. Manufacture and supply chains are expanding across the globe and becoming more complex, which increases the potential for counterfeit or substandard products to enter the supply chain. There is increasing pressure to bring novel therapeutic products to market faster and with less bureaucracy; however, this is also met with a decreasing tolerance for problem products. Advances in digital technology have opened up opportunities for better regulation of medicines, including opportunities to work together with partners in the health and care system for mutual benefit. The Office helps companies, small‐ and medium‐sized enterprises (SMEs), academics and individuals who are developing a novel medicine or device, or a novel approach to the development or manufacture of a product, to understand what is required to progress their product through the regulatory processes.
The Office has proven to be successful in encouraging early dialogue between companies or academics and the Agency, and provides regulatory and scientific support to such groups in their interaction with the regulatory environment. However, in addition to this, the advent of the internet has also led to an increase in the illegal supply of pharmacy‐only and prescription‐only medicines online. Another area of focus nationally has been the holding of scientific meetings to ensure that regulators understand emerging science and can therefore ensure that regulation can keep up with science.
A modern‐day regulator must stay at the forefront of new technologies to address innovation drivers, increase patient access to new medicines and remain up to date with new scientific developments to ensure that regulatory science keeps pace with academia.
The MHRA supports innovative product development by various means. Regular horizon scanning is important to identify new science and scientific methods that may have an impact on the regulation of products. The Agency also offers advice in various formats, including helplines, via the Innovation Office; provision of scientific advice or joint advice with other bodies, such as the National Institute for Health and Care Excellence (NICE); or, in the case of regenerative medicines, provides a ‘one‐stop shop’ for advice. The Agency also publishes guidance and hosts scientific meetings to keep informed of advancements in a drug’s development. The EAMS scheme follows two stages – firstly, a drug is assigned a new Promising Innovative Medicine (PIM) designation to provide an early indication that a product may be a possible candidate for EAMS; and, secondly, the MHRA issues a new benefit–risk scientific opinion based on the information available at the time of application. The previously existing mechanisms for the use of unlicensed medicines, such as named patient use/compassionate use, are still in place; however, the EAMS scheme has the advantage of a robust regulatory decision to support such use. It is imperative that the Agency remains an influential body at a European and an international level because of the increasing globalization of the pharmaceutical and device industries, and the supply chain.
Medicines regulation is evolving rapidly in response to the very many changes in the environment in which it operates. These include the increasing globalization of the industries we regulate, increasing diversity and complexity of new products, need to support safe innovation to enable benefits for public health, need to be much more flexible in approach and make better use of the regulatory flexibilities allowed in legislation, need to increase patient involvement transparency in decision making, need to adapt to the digital age, and the need to strengthen vigilance, increasing proactive approaches and real‐time risk–benefit monitoring. The role of the regulator is therefore changing rapidly, with the introduction of new approaches which are more flexible and more risk proportionate. International collaboration is a key element of the work of regulators, and is set to expand.