Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
Similar Posts
Decision: Advertising Investigations: January 2026
Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.
MHRA approves UK’s first anti-PD-1 monoclonal antibody for treatment of aggressive form of lung cancer
As with all products, we will keep its safety under close review
Guidance: Report on Adverse Event (AE) reporting in digital mental health technologies (DMHTs) and the development of updates to regulatory guidance
Advice for manufacturers of DMHTs that qualify as software as a medical device (SaMD) on understanding new post marketing surveillance rules and examples of how they apply.
Guidance: MORE Submissions – user reference guide
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
Good pharmacovigilance practice (GPvP)
Comply with good pharmacovigilance practice and prepare for an inspection.
Form: Medicines marketing authorisation: change of ownership application
Use this form to transfer a product licence, also known as a marketing authorisation, to a different owner.
