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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 Medicines and Healthcare products Regulatory Agency (MHRA) became a…
Consultation on proposals to update the MHRA's statutory fees to ensure they continue to recover their costs.
The MHRA is inviting members of the public to provide their views on proposed changes to the regulatory framework for medical devices.
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…
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.
MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices.
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
Public consultation on proposals to allow pharmacists to dispense prescription medicines in original packaging, in particular those containing sodium valproate.
First published during the 2019 to 2022 Johnson Conservative government
The aim of this consultation is to seek the views of stakeholders on proposals for changes to the Medicines and Healthcare products Regulatory Agency’s statutory fees.
We’d value your views to help shape the introduction of a new regulatory framework for products supplied at the point of care.
We are consulting on a set of proposals to improve and strengthen the Code of Practice for experts who provide advice on which decisions about the regulation of medicines and medical devices are based, to ensure that experts…
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