UK regulation of in-orbit pharmaceutical manufacturing

The UK Space Agency, the Medicines and Healthcare Products Regulatory Agency (MHRA), the Regulatory Innovation Office (RIO) and the Civil Aviation Authority (CAA) have published a joint statement outlining how they will work together to support the development of in‑orbit manufacturing of pharmaceuticals in the UK.

Transformational

In‑orbit manufacturing of pharmaceuticals offers transformative potential across multiple domains, including precision medicines for oncology and rare diseases and improved drug stability for remote and crisis‑affected populations.

Key focuses

The joint statement explains how the regulators intend to provide a co‑ordinated and supportive regulatory environment for companies operating across the space, biopharma and pharmaceutical sectors. The key focuses are:

• Collaboration – creating a joined up regulatory approach;
• Navigating a new regulatory pathway for space‑manufactured medicines;
• Exploring the benefits of microgravity; and
• Initiatives to support the growth of in-orbit manufacturing.

The UK Space Agency is leading a range of initiatives aimed at supporting the growth and development of the in‑orbit pharmaceuticals sector. To support innovators directly, the UK Space Agency and Innovation Accelerator team at MHRA are preparing principles‑based case studies that will outline clear regulatory routes for space, biotech and pharmaceutical companies.

These initiatives will help ensure that the UK remains a world‑leading destination for life sciences and advanced space technologies.

Should you require further advice on this exciting development please contact the authors or your usual DLA Piper contact.