Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

UK’s Early Access To Medicines Scheme To Get New Legal Basis

Executive Summary

Legal clarity around the core principles of the UK’s early patient access scheme is expected to benefit the pharma industry, patients and healthcare professionals.

You may also be interested in...



UK Clarifies RWD Collection Rules Under Early Access Scheme

New UK guidance says companies do not have to apply for clinical trial approval or ethics review to collect data on the clinical management of patients receiving unapproved drugs under an early access scheme. However, consent is needed where such data may have research value once collected.

New UK Drug Applications At ‘Sustained Levels’ Post-Brexit

The MHRA’s chief executive explains to the Pink Sheet how the agency will ensure the UK remains an attractive place to seek approval of new innovative drugs and build on the regulatory flexibilities introduced during the COVID-19 pandemic.

UK Wants Early Access Scheme To Remain ‘Relevant And Attractive’ Following Brexit

The MHRA has drawn up measures to improve regulatory certainty around the UK’s early patient access scheme while reducing regulatory burden in certain areas of its operation.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS145628

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel