The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological medicines.
Public quality standards form part of the regulatory framework governing the quality of all medicines. Both documentary and physical standards exist to ensure that medicines are of acceptable quality for use by patients. Documentary standards set minimum quality attributes such as identity, potency and purity, and also include descriptions of analytical methods used to demonstrate these criteria. In the UK, documentary pharmacopoeial quality standards are published in the British Pharmacopoeia.
The MHRA recognises the increasing importance of biological medicines and is therefore developing a strategy for documentary pharmacopoeial quality standards specifically for biological medicines. The new strategy aims to ensure consistent manufacturing and acceptable levels of safety and efficacy across biological medicines through the development of new standards for manufacturers, regulatory authorities and independent testing laboratories. It is also intended to encourage innovation through standards for the use of new innovative technologies.
Key elements of the strategy include:
- An assessment of current and potential alternative approaches for the development of general and medicine-specific standards;
- Collaboration with industry and other stakeholders in the establishment of standards and to increase the MHRA’s existing knowledge on quality control practices used by manufacturers;
- A review of the current biological standards and the need for new and revised standards; and
- Collaboration with national initiatives and international regulatory and pharmacopoeial agencies to adopt best practices.
The MHRA will also continue to develop physical standards for biological medicines, published by the National Institute for Biological Standards and Control.
Stakeholders are invited to submit comments on the biological medicines market, the need for standards and how the MHRA can collaborate with stakeholders. The consultation closes on 10 April 2017. The consultation document and response form are available here.