Who is the MHRA?

Dr. Satish Singh is an Expert Clinical Assessor in licensing division at the Medicine and Healthcare Products Regulatory Agency (MHRA) in the UK, where he has worked for the past 22 years. In this guest column he talks about what the MHRA does and why

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The Medicines and Healthcare Products Regulatory Agency (MHRA) is the National Competent Authority for the United Kingdom. It is responsible for the authorisation and safety monitoring of medicines and devices on the UK market. It is also a competent authority for clinical trials conducted in the UK. As the UK is a member of the European Union, the Agency is actively involved in European Licensing procedures through the European Medicines Agency. While the MHRA's primary responsibility is to protect public health by overseeing the safety, quality and efficacy of all medicines and devices on the UK market, its contribution to European procedures through the Centralised, Decentralised and Mutual Recognition routes is well recognised. The robust assessment of scientific data submitted with the applications and its scientific expertise, both in-house and external, is highly regarded in the European Union and internationally.

The Commission on Human Medicines (CHM) provides an external, impartial review of MHRA proposals. The conclusions of MHRA assessment teams, for most applications, are also reviewed by the Commission. The CHM and other scientific committees have the highest level of external scientific expertise. This ensures that the Agency takes into account the opinion of leading scientists in their field in the United Kingdom while considering biological products as well non-biological products.

The MHRA proactively engages with industry by holding conferences, providing important information through its website and consultation on significant issues that impact stakeholders. These include development of guidelines, both national and European. In addition, it provides scientific and regulatory advice to companies through its scientific advice meetings and general guidance through the Regulatory Information Service (RIS). Around 250 scientific advice meetings are held each year with pharmaceutical and biotechnology companies from around the world to provide advice concerning their quality, preclinical and clinical development programmes.

Some changes that have either occurred recently or will come into force in the near future will greatly increase the size, scientific expertise and effectiveness of the MHRA. These include the merger of the National Institute for Biological Standards and Control (NIBSC) with the MHRA, an enhanced Clinical Practice Research Database (CPRD) and pharmacovigilance legislation. The change to Clinical Trials Regulations and Medical Devices Regulations are under negotiation at present. They are expected to come into force from 2016 and 2017 respectively. The Falsified Medicines Directive has also been implemented from early this year.

NIBSC has statutory responsibility for biological medicines on the UK market. It is responsible for the preparation and distribution of international standards for biologicals, working in collaboration with the WHO. NIBSC also collaborates with the European Commission and other international organisations as regards testing of biological substances, establishment of standards and standard preparations. NIBSC has particular expertise in bio-analytical technology and has a global reputation for excellence and integrity. It produces >90% of International Standards for biological medicines (WHO International Laboratory for Standards) and hosts the UK stem cell bank.

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