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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.
We invite feedback on the operation and impact of the human medicines and medical devices legislation as part of a statutory review required under the Medicines and Medical Devices Act 2021.
DHSC is seeking views on proposals to modernise legislation governing the supervision of activities by a pharmacist in a pharmacy.
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 …
This consultation seeks views on proposals to update the statutory scheme to control the cost of branded health service medicines.
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…
This consultation is seeking views on changing the upper age of age exemptions on prescription charges.
First published during the 2019 to 2022 Johnson Conservative government
The government’s plan to build a circular economy for medical technology to increase resilience, drive growth, realise cost savings and improve sustainability.
Factsheet providing more information on the Commission on Human Medicines' independent report on the safety implications of proposed puberty blocker legislation.
Policy statement setting out case studies for the sale of hearing aids in the UK.
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.
The MHRA’s strategy for Improving Safety Communications for 2024 to 2027.
We are seeking views on the legislation that will enable the GMC to regulate anaesthesia associates (AAs) and physician associates (PAs) in the UK.
First published during the 2022 to 2024 Sunak Conservative government
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 UK Government is consulting on proposed legislative amendments to widen access to take-home supplies of naloxone, without a prescription.
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