Foreword

The complex global life sciences environment reflects ever-increasing diversity and innovation in medicine. This is demonstrated by the exciting developments in the fields of gene and cell therapy, the expansion in the availability of biosimilars and the adoption of advanced manufacturing innovation in the biopharmaceutical sector, such as continuous manufacture and the application of Quality by Design (QbD).

The UK government has made life sciences a key focus with the publication of the Accelerated Access Review¹ in 2016 on how best to access innovation for the benefit of patients, followed by the recent industrial strategy green paper² published in January 2017, which highlighted the UK’s leading, global role in life sciences. Similarly the Medicines and Healthcare products Regulatory Agency Corporate Plan³ identifies ‘Enabling innovation’ and ‘Secure global supply chains’ as important strategic themes in a fast-changing scientific landscape.

The British Pharmacopoeia (BP) is actively engaged in meeting the challenges and opportunities that these changes present and ensuring that our products and services meet the needs of our users now and in the future. For example, supporting and enabling innovation through our work to develop an Agency-wide strategy for pharmacopoeial biological quality standards, reflecting the growing importance of biological medicines to global public health. In addition to this, the action identified in the Medicines Manufacturing Industry Partnership action plan⁴ on advanced therapies manufacturing, for the BP to explore – in collaboration with our colleagues in the Medicines and Healthcare products Regulatory Agency and the National Institute of Biological Standards and Control – the role standards can play in this developing field of medicine. Finally our unique feasibility study on the application of Quality by Design concepts to analytical procedures also demonstrates our commitment to exploring innovative approaches to setting quality standards for medicines.

Amidst the unrelenting pace of innovation and global change, the British Pharmacopoeia’s mission continues to be to ensure the quality of medicines and the protection of public health.

Professor Sir Michael Rawlins

Chairman

Medicines and Healthcare products Regulatory Agency