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This guidance relates to Technical Standards and Standard Development Organisations to describe the typical first step in a Standard Essential Patent (SEP) journey.
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect 23 July 2025.
Guiding principles for the use of predetermined change control plans (PCCPs) for managing rapid product changes in medical devices.
Check the tariff classification for automated component placement machines used to manufacture printed circuit assemblies.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
Guidance to help you assess if artificial intelligence (AI) is the right technology for your challenge.
Find out when you can use rebated diesel, biodiesel or kerosene in vehicles and other machinery.
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