Biological Quality In The Spotlight As UK MHRA Consults On Standard-Setting

Quality standards for biological medicines are in the spotlight again, with the UK medicines regulator, the MHRA, in the midst of consulting stakeholders on how to ensure that publicly available monographs are suitable for biologicals in the future.

The UK Medicines and Healthcare products Regulatory Agency is in the midst of a consultation that it hopes will elicit some solid stakeholder input into a proposed strategy for reviewing existing quality standards for biological medicines and determining the need for new and revised standards.

Stakeholders have been asked to give their opinions on a range of issues, such as what they see as the biggest opportunities and challenges for biological medicines over the coming five years, whether there are any unmet needs in terms of standards for new drugs, how quality standards can facilitate innovation across the product lifecycle, and how the MHRA can work with stakeholders to develop the most appropriate standards in future.

The agency said the move was part of broader efforts to help manufacturers make use of new and innovative tools, including the Early Access to Medicines Scheme and the activities of the MHRA’s Innovation Office, and that the strategy would also support cross-government and industry initiatives like the Strategy for UK Life Sciences and the Advanced Therapies Manufacturing Action Plan.

It said it hoped to be an “early adopter and driver of new and innovative approaches in standards-setting for biological medicines,” which will be of increasing importance in the healthcare landscape as many more biologicals, including advanced therapy medicinal products (ATMPs), become available and account for a larger proportion of healthcare spending.

Biological standards come in both documentary and physical form, and are used to ensure the quality of biological medicines. The documentary standards are written descriptions of the quality requirements that drugs have to meet, and in the UK they are published by the British Pharmacopoeia, which is part of the MHRA.

Physical standards are materials used as benchmarks in scientific tests used to demonstrate those quality requirements, and are produced by the National Institute for Biological Standards and Control, with which the MHRA merged in 2013.

Christian Schneider, director of the NIBSC, said a central element of the institute’s mission was to “promote international standardization and harmonization to assure the safety and efficacy of biological medicines. The successful merger with the Medicines and Healthcare products Regulatory Agency in 2013 has created important synergies, continuing our global leadership in this field.”

“We want to ensure that our pharmacopoeial standards are fit for the future and that they enable innovation” – Samantha Atkinson, scientific director of the British Pharmacopoeia

Part of the proposed strategy is to bring together the combined expertise of the regulatory, biological and standard setting functions of the MHRA “to ensure we continue to remain at the forefront of the development of biological quality standards” in the UK and at international level, according to the agency.

It plans to review the current approach taken for developing quality standards for biologicals over the next five years. “We want to ensure that our pharmacopoeial standards are fit for the future and, really importantly, that they enable innovation,” Samantha Atkinson, scientific director of the British Pharmacopoeia, told the Pink Sheet. “This whole process is a fact-finding activity to see what others think and get their opinions on what biological standards could look like.”

She said the MHRA wanted “to be innovative and to enable innovation, at the same time as promoting and contributing to quality and safety. It is about moving with the times and adapting, and we are able to do that.”

The agency was keen to stress that it would be working closely with its stakeholders, including the biopharmaceutical industry, on establishing the pharmacopoeial standards, as well as building up its own knowledge of biological manufacturing processes by working with industry and other partners to “increase mutual understanding of challenges in the control of biological quality and the development of pilot projects to explore potential solutions.”

Atkinson said the agency already had “a very good relationship with all the different stakeholders that we work and collaborate with, both nationally and internationally, and that is across the regulatory arena but also across the industry, including the biopharmaceutical network. This consultation demonstrates exactly our commitment to this sort of work and to stakeholder engagement.”

She said the MHRA worked with all its counterparts around the globe “because we have a global supply chain, and for these things to move forward we need contributions from representatives across the regulatory and industry landscapes. That is why we are very keen to obtain feedback from all of the different stakeholders.”

The consultation ends on April 10. Once it is complete, Atkinson said, the MHRA will look at the various responses and feedback and then publish the outcome and consider the way forward. “A key aspect of this will be to consider how the standards will look in the future and the process for developing them. One thing that is absolutely key is that we will be working with our stakeholders very closely,” she said, adding: “We are already getting a significant amount of engagement and arranging a number of meetings, so it has been very positive.”

Stakeholders wishing to comment or ask questions can contact [email protected].

From the editors of Scrip Regulatory Affairs.