Medicines Regulation

The BIA plays a leading role in speaking for the UK life sciences industry on regulation that affects the clinical development and approval of new, innovative medicines. The BIA works both on its own and with partner organisations, both domestically and in the EU, to ensure a coherent approach to regulatory activities.

BIA regulatory affairs strategic objectives:

  • Reflect the interests of both SMEs and mid-to-large biopharmaceutical companies
  • Influence regulators and policy makers concerning legislative and policy changes and initiatives affecting the life sciences industry
  • Advocate and provide BIA unique insights for a supportive regulatory environment for R&D and innovation in the UK and EU
  • Maintain strong relationships with key UK and EU regulators and engage with HTA bodies
  • Develop the future UK medicines regulatory framework post-Brexit

The BIA meets regularly with senior officials from the Medicines and Healthcare products Regulatory Agency (MHRA) and key members of the Agency's advisory bodies. The BIA in partnership with the MHRA hold joint annual regulatory conferences (http://www.biamhraconference.org/).

The BIA has a strong relationship with the European Medicines Agency (EMA) and participates in meetings/workshops on topics of common interest.

The BIA is leading in collaboration with partner organisations to address the practical issues and challenges following the EU Referendum outcome and secure a European partnership for medicines regulation post-Brexit.

To improve access to innovative medicines, we support and contribute to the development of accelerated regulatory pathways (e.g. EAMS, PRIME, adaptive pathways), and collaborate with the National Institute for Health and Care Excellence (NICE) (e.g. data sharing during the regulatory process).