№ lp_2_1_24902
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This document outlines the partnership between MHRA and NICE to establish an Innovative Licensing and Access Pathway for medicines post-Brexit, focusing on regulatory changes and the development of tools to ensure timely access to safe and effective medicines in the UK healthcare system.
Year:
2020
Region / City:
UK
Theme:
Health, Medicine Regulation
Document Type:
Report
Organization:
National Institute for Health and Care Excellence, Medicines and Healthcare products Regulatory Agency
Author:
Meindert Boysen, Felix Greaves
Target Audience:
Healthcare professionals, regulatory bodies, industry partners
Action Period:
From January 2021
Approval Date:
November 2020
Modification Date:
Not specified
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Year:
2025
Organization:
Medicines and Healthcare products Regulatory Agency (MHRA)
Partner Organization:
The National Institute for Health and Care Excellence (NICE)
Document Type:
Guidance / Application Form
Subject:
Real-World Evidence (RWE) Scientific Dialogue
Target Audience:
Pharmaceutical companies, academic institutions, and other organizations generating RWE
Application Period:
10 February 2025 – 4 April 2025
Meeting Dates:
May – July 2025
Workshop Dates:
June – July 2025
Scope:
Medicinal products including drugs, biologics, vaccines, ATMPs; pre- and post-authorisation evidence generation
Exclusions:
Medical devices, products under active regulatory procedure
Submission Method:
Email to [email protected]
Format:
Closed-door meetings or pre-competitive workshops
Page Limit:
3 pages
Year:
Not specified
Project Duration:
3 months
Setting:
GP surgery / primary care practice
Country:
Not specified
Topic:
Prescription safety and regulatory drug alerts
Document Type:
Quality Improvement Project (QIP) report with supervisor feedback
Organisation Referenced:
Medicines and Healthcare Products Regulatory Agency
Clinical Focus:
Drug interactions involving tamoxifen and CYP2D6 inhibitors
Trigger Event:
Identification of a patient prescribed tamoxifen and fluoxetine contrary to MHRA advice
Regulatory Reference:
‘Drug interactions involving CYP2D6, genetic variants, and variability in clinical response’ (November 2010)
Project Aim:
Implementation of a systematic process to disseminate and action MHRA alerts within 2 weeks
Methods Used:
Process mapping; development of a new protocol; team discussion
Intervention:
Appointment of a clinical lead and administrative support to review, disseminate, and action MHRA alerts
Evaluation Approach:
Informal team feedback; no quantitative outcome data presented
Supervisor Assessment:
Mixed ratings (BE, ME, AE) across sections
Intended Audience:
GP trainees and supervisors
Year:
2026
Region / City:
England
Subject:
Community pharmacy updates, medicine shortages, regulatory notices
Document Type:
Newsletter
Organization:
Community Pharmacy England
Author:
Community Pharmacy England Communications Team
Distribution Frequency:
Mondays, Wednesdays, and Fridays
Key Topics:
Medicine shortages, Category H guidance, Pharmacy First service, MHRA recalls
Related Reports:
House of Lords Public Services Committee report on medicines security, Pharmacy Pressures Survey 2025: Medicines Supply Report
Webinars:
Category H webinar on 16th February 2026
Contact:
14 Hosier Lane, London EC1A 9LQ; Tel: 0203 1220 810; Email: [email protected]
Year:
2022
Region / city:
UK
Theme:
Diabetes care, structured education
Document type:
Report
Organization / institution:
National Institute for Health and Care Excellence (NICE)
Author:
National Institute for Health and Care Excellence
Target audience:
Healthcare professionals, CCGs
Validity period:
2014/15 - ongoing
Approval date:
March 2022
Review date:
March 2023
Year:
2005
Region / City:
United Kingdom
Topic:
Healthcare, Bioethics, Public Health
Document Type:
Guidance
Organization / Institution:
National Institute for Health and Clinical Excellence (NICE)
Author:
National Institute for Health and Clinical Excellence (NICE) Board
Target Audience:
Those involved in developing or revising NICE guidance, NICE’s advisory bodies, stakeholders, and the general public
Period of Effectiveness:
Ongoing
Approval Date:
2005
Date of Changes:
Not specified
Year:
2023
Region / City:
United States
Theme:
Cybersecurity, Workforce Development
Document Type:
Interview
Organization:
U.S. Department of Homeland Security (DHS)
Author:
Gregory Bird
Target Audience:
Cybersecurity professionals, Human Resources in cybersecurity
Period of Action:
Ongoing
Approval Date:
Not provided
Date of Changes:
Not provided
Year:
1985
Region / City:
CEPT countries
Topic:
Radio Amateur Licensing
Document Type:
Recommendation
Organ / Institution:
CEPT
Author:
CEPT
Target Audience:
Radio Amateurs, CEPT administrations, non-CEPT administrations
Period of Validity:
Ongoing
Date of Approval:
1985
Date of Amendments:
May 2016, February 2023, June 2022
Note:
Context
Date:
September 25, 2024
Year:
2024
Region / City:
Geneva
Topic:
Intellectual Property
Document Type:
Report
Organization:
WIPO
Target Audience:
WIPO Member States
Period of validity:
From July 9 to 17, 2024
Date of adoption:
Not specified
Date of amendments:
Not specified
Year:
2019
Region / City:
United Kingdom
Topic:
Chronic Obstructive Pulmonary Disease (COPD), Oxygen Saturation
Document Type:
Guidance
Organization:
National Institute for Health and Care Excellence (NICE)
Author:
NICE
Target Audience:
General practitioners, healthcare professionals
Period of Validity:
Not specified
Approval Date:
August 2019
Date of Last Update:
N/A
Year:
2022
Region / City:
England
Theme:
Health Inequalities
Document Type:
Final Report
Organization / Institution:
National Institute for Health and Care Excellence (NICE)
Author:
NICE
Target Audience:
General public, policymakers, health professionals
Period of Validity:
2021-2026
Approval Date:
January 2022
Date of Changes:
None
Year:
2021
Region / city:
N/A
Subject:
Clinical guideline
Document type:
Indicator guidance
Organization / institution:
National Institute for Health and Care Excellence (NICE)
Author:
N/A
Target audience:
Healthcare professionals, Clinical commissioning groups
Period of validity:
N/A
Approval date:
August 2021
Date of updates:
N/A
Year:
2021
Region / City:
San Antonio, Texas
Theme:
Cybersecurity Workforce Development
Document Type:
Interview
Institution:
National Initiative for Cybersecurity Education (NICE)
Author:
Rodney Petersen, Chris Knox
Target Audience:
Cybersecurity professionals, organizational managers
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Modifications:
Not specified
Year:
2019
Region / city:
England
Topic:
Heart failure diagnosis, clinical guidelines
Document type:
Guidance
Organization / institution:
National Institute for Health and Care Excellence (NICE)
Author:
National Institute for Health and Care Excellence (NICE)
Target audience:
Healthcare professionals, general practitioners
Period of validity:
N/A
Approval date:
August 2019
Date of updates:
N/A
Year:
2019
Region / City:
England
Topic:
Heart Failure, Treatment, Cardiovascular Disease
Document Type:
Guidance
Organization:
National Institute for Health and Care Excellence (NICE)
Author:
National Institute for Health and Care Excellence
Target Audience:
General practitioners, healthcare providers
Period of validity:
Ongoing
Approval Date:
August 2019
Date of Changes:
N/A
Year:
2019
Region / city:
United Kingdom
Topic:
Mental health, Alcohol use
Document type:
Guidance
Organization / institution:
National Institute for Health and Care Excellence (NICE)
Author:
National Institute for Health and Care Excellence
Target audience:
Healthcare professionals
Period of validity:
N/A
Approval date:
August 2019
Date of last update:
N/A
Year:
2013
Region / City:
United Kingdom
Topic:
Patient group directions, healthcare professionals, NICE guidance
Document Type:
Framework
Organization / Institution:
National Institute for Health and Care Excellence
Author:
National Institute for Health and Care Excellence
Target Audience:
Health professionals, commissioners, and healthcare providers
Effective Period:
From August 2013
Approval Date:
August 2013
Last Updated:
January 2018
Date of Amendments:
January 2018
Year:
2016
Region / city:
York, UK
Topic:
Gene therapy for ADA-SCID
Document type:
Review article
Organization / institution:
National Institute for Health and Care Excellence (NICE)
Author:
Emily South, Edward Cox, Nick Meader, Nerys Woolacott, Susan Griffin
Target audience:
Healthcare professionals, decision-makers in health technology assessment
Period of validity:
2016
Approval date:
May 2016
Date of changes:
Not specified
Country:
Wales
Region:
All Wales
Subject:
COVID-19 pandemic response and medicine access
Document type:
Submission form
Issuing body:
NHS Wales
Related organisation:
NHS England
Coordinating body:
All Wales Therapeutics and Toxicology Centre (AWTTC)
Purpose:
Submission of information on medicines for use during the COVID-19 pandemic
Required attachments:
Documentation shared with NHS England
Submission method:
Email to [email protected]
Note:
or file share via the Vault
Key data fields:
Licence holder, medicine name, indication, licence status, type of supply, clinical benefits, comparator treatments, place in therapy, eligible patient numbers, pricing details, administrative costs, reimbursement arrangements, contact details
Public health context:
COVID-19 pandemic
Target respondents:
Pharmaceutical companies or licence holders
Year:
2020
Region / city:
Global
Theme:
Biodiversity, Conservation
Document Type:
Evaluation Report
Agency / Institution:
United Nations Development Programme (UNDP)
Author:
José Galindo
Target audience:
Stakeholders in conservation and biodiversity
Period of validity:
2016-2020
Approval date:
October 2015
Date of amendments:
Not specified