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Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the correct safety information.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Activase Pharmaceuticals Limited is recalling two batches of Prednisolone 5mg Soluble Tablets as a precautionary measure due to a limited number of reports of blister pockets becoming swollen over time.
As many people consider lifestyle changes at the start of the year, the Medicines and Healthcare products Regulatory Agency (MHRA) is urging the public to make sure any weight-loss medicines they use are safe, effective and legitimate.
Viatris has received reports of brown discolouration and blockage in the needle of pre-filled syringes of Arixtra. This quality defect is related to oxidation of the syringe needle.
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