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To assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of investigational medical products.
Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
Guidance for industry on preparing responses to good laboratory practice (GLP) and good clinical practice (GCP) inspection reports.
Update on MHRA UK risk-based GxP inspection programme.
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How to best protect patients and volunteers during magnetic resonance imaging (MRI) examinations.
Guidance for industry on flexible approaches we are taking on good distribution practices.
Guidance and specifications for the recording and extraction of CTAD data from laboratories in England processing LA and NHS commissioned chlamydia tests.
A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
Data submission requirements for acute, community and private microbiology services submitting data on all LA/NHS chlamydia tests done in England.
Poster with advice for healthcare professionals on how to carry out point of care testing safely and correctly.
On this page the Medicines and Healthcare Products Regulatory agency provides advice for producers of E-cigarette/vape products
Guidance on moving medicines by air
We are allowing alternative courses of actions for manufacturing or laboratory equipment during the outbreak.
These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
Industry must notify the MHRA if they will not be using these flexibilities
The UK Good Laboratory Practice Monitoring Authority (UK GLPMA) recognises that there are potential challenges COVID-19 will present to members of the GLP monitoring programme.
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