Essential Terms for UK Quality Regulations Post-Brexit
Many biotechs are struggling with the uncertain state of quality regulations in the Post-Brexit UK. Understanding the new regulatory processes and requirements begins with understanding the key terms in a new MasterControl article, Joanna Blair breaks down the top 11 terms you need to know to navigate the current regulatory landscape to ensure compliance. To start, companies must know the importance of UKCA and CE markings.
The UK’s New Approach to Market Access: Innovative Licensing and Access Pathway
Brexit signaled a major shift in medicine regulation in the UK, with the Medicines and Healthcare Products Regulatory Agency (MHRA) [...]
Preparing for UK Medical Device Regulations: 4 Ways to Get Ready
With new guidance from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for regulated medical devices, companies are facing [...]
NHS Trust Aims for 90% Electronic Patient Records by 2023
Sajid Javid, the UK Health Secretary, has set a goal for 90% of NHS trusts to implement electronic patient records [...]
UK’s NICE Becomes Single Access Point for Covid-19 Guidance
The National Institute for Health and Care Excellence (NICE) announced that will it host a new, single point of advice [...]
NICE Seeks to Simplify Selection Process for Drug and Medical Device Evaluation
NICE is seeking public input on changing the process it uses to selects the topics it develops guidance on. The [...]