About the ABPI

The ABPI represents innovative resea​rch-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.

Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. We represent companies who supply more than 80 per cent of all branded medicines used by the NHS and who are researching and developing the majority of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome disease.

Globally our industry is researching and developing more than 7,000 new medicines.

The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry for statutory consultation requirements including the pricing scheme for medicines in the UK.​​​​​​​

To get up to speed on the latest developments, the next briefing points from the BIA/ABPI are as follows:

Key themes and questions included in the consultation document

The scope of this consultation includes proposals from the MHRA on how it would handle various issues in the scenario of the UK not securing a deal with the EU after the UK’s exit from the EU. Topics covered by the consultation questions include:

  • Legal presence
  • New Marketing Authorisation assessment routes
  • Converting Centrally Authorised Products to UK Marketing Authorisations
  • Packaging
  • Paediatrics Investigations Plans and studies
  • Orphan designation
  • Abridged applications
  • Increased requirements for needing a manufacturer’s licence for import or a wholesaler dealer’s licence
  • Recognition of prescriptions
  • Clinical trials – legal presence, transparency, use of designated country lists and costs
  • Medical devices – registration and costs
  • Fees – waivers for orphan products, MHRA fees for processes previously provided by the EC/EMA and costs
  • Future operation of NIBSC

Media enquiries

+44 (0) 20 7747 7147​​