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The MHRA is consulting with UK stakeholders to gather feedback and comments on an international guideline on the assessment and control of extractables and leachables.
We are seeking feedback on our new draft guideline on individualised mRNA cancer immunotherapies, a new type of cancer treatment being tested in clinical trials. This will help us to clarify and streamline pathways for bring…
Consultation on proposals to update the MHRA's statutory fees to ensure they continue to recover their costs.
Executive summary This is a consultation document lead by the Medicines…
The MHRA is consulting with UK stakeholders to gather feedback and comments on a revised international guideline, M4Q(R2).
The MHRA is consulting with UK stakeholders to gather feedback and comments on ICH E20, a new international guideline.
The MHRA is inviting members of the public to provide their views on proposed changes to the regulatory framework for medical devices.
MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices.
The MHRA is consulting with UK stakeholders to gather feedback and comments on a new international guideline for the appropriate inclusion and/or retention of pregnant and/or breast-feeding individuals in clinical trials of …
We invite feedback on the clarity and wording of our new draft guideline on the use of external control arms based on real-world data to support regulatory decisions.
The ICH Expert Working Group for ICH E6(R3) (EWG) has been updating the ICH E6(R2) GCP guideline. The MHRA represents the Pharmaceutical Inspection Co-operation Scheme (PIC/s) in the EWG.
The ICH Expert Working Group (EWG) for ICH M13B has been drafting the second guideline in the series which describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) asses…
The ICH Expert Working Group for ICH M15 (EWG) has been drafting the ICH M15 MIDD guideline. The MHRA attended the EWG meetings and participated in the drafting group.
Consultation on the ICH E2D(R1) guidelines on General principles on plan, design, and analysis of pharmacoepidemiological studies that utilise real-world data for safety assessment of medicines.
The Medicines and Healthcare Products Regulatory Agency (MHRA) have launched a public consultation to propose reclassification of Codeine Linctus to prescription-only medicine.
This is a consultation on a statutory instrument to amend the Human Medicines Regulations 2012 to remove the provision which provides the legal basis to the European Commission Decision Reliance Procedure (ECDRP).
The MHRA is reviewing its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices.
Public consultation on a set of proposals to make Aquiette 2.5mg Tablets (oxybutynin hydrochloride) available from pharmacies
The Medicines and Healthcare products Regulatory Agency (MHRA) became a full member of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in May 2022 and is consulting w…
Call for information to support a review of isotretinoin, a treatment for severe acne. This review is being undertaken by the Medicines and Healthcare products Regulatory Agency with advice from the Commission on Human Medic…
We are consulting on a set of proposals to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and develop safe and innovative medicines
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