Cargando…

Use of real-world evidence in postmarketing medicines regulation in the European Union: a systematic assessment of European Medicines Agency referrals 2013–2017

OBJECTIVES: To assess the use, and evaluate the usefulness, of non-interventional studies and routinely collected healthcare data in postmarketing assessments conducted by the European Medicines Agency (EMA). DESIGN: We reviewed and systematically assessed all referrals to the EMA made due to safety...

Descripción completa

Detalles Bibliográficos
Autores principales:	Brown, Jeremy Philip, Wing, Kevin, Evans, Stephen J, Bhaskaran, Krishnan, Smeeth, Liam, Douglas, Ian J
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2019
Materias:	Pharmacology and Therapeutics
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6830614/ https://www.ncbi.nlm.nih.gov/pubmed/31662354 http://dx.doi.org/10.1136/bmjopen-2018-028133

Ejemplares similares

Stratified medicine in European Medicines Agency licensing: a systematic review of predictive biomarkers
por: Malottki, Kinga, et al.
Publicado: (2014)

Valorising and Creating Access to Innovative Medicines in the European Union
por: Annemans, Lieven, et al.
Publicado: (2011)

The challenges of access to innovative medicines with limited evidence in the European Union
por: Vallano, Antonio, et al.
Publicado: (2023)

Cell-based medicinal products approved in the European Union: current evidence and perspectives
por: Bellino, Stefania, et al.
Publicado: (2023)

Real-world evidence (RWE): A challenge for regulatory agencies discussion of the RWE conference with the network of the european medicine agencies, patients, and experts
por: Maison, Patrick, et al.
Publicado: (2022)

Affordability of medicines in the European Union
por: Zaprutko, Tomasz, et al.
Publicado: (2017)

Availability and Affordability of Drugs With a Conditional Approval by the European Medicines Agency; Comparison of Korea With Other Countries and the Implications
por: Kwon, Hye-Young, et al.
Publicado: (2018)

Investigation assessing the publicly available evidence supporting postmarketing withdrawals, revocations and suspensions of marketing authorisations in the EU since 2012
por: Lane, Samantha, et al.
Publicado: (2018)

Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study
por: Zeitoun, Jean-David, et al.
Publicado: (2017)

European Union ban on Ayurvedic Medicines
por: Patwardhan, Bhushan
Publicado: (2011)

Psychopharmacology at the era of EMEA (European Medicines Agency)
por: Pestana, Luis Camara, et al.
Publicado: (2010)

A bacteriophage journey at the European Medicines Agency
por: Debarbieux, Laurent, et al.
Publicado: (2015)

Reimbursement of Orphan Drugs in Europe in Relation to the Type of Authorization by the European Medicines Agency and the Decision Making Based on Health Technology Assessment
por: Malinowski, Krzysztof Piotr, et al.
Publicado: (2018)

Patient-Reported Outcome Measures in Oncology Drugs Approved by the European Medicines Agency, 2017-2021
por: Ciani, Oriana, et al.
Publicado: (2023)

The European Medicines Agency's approval of new medicines for type 2 diabetes
por: Blind, Eberhard, et al.
Publicado: (2018)

Licensing of Orphan Medicinal Products—Use of Real-World Data and Other External Data on Efficacy Aspects in Marketing Authorization Applications Concluded at the European Medicines Agency Between 2019 and 2021
por: Naumann-Winter, Frauke, et al.
Publicado: (2022)

Candida auris: epidemiological situation, laboratory capacity and preparedness in European Union and European Economic Area countries, 2013 to 2017
por: Kohlenberg, Anke, et al.
Publicado: (2018)

Patient-reported outcome measures in drugs for neurological conditions approved by European Medicines Agency 2017–2022
por: Ciani, Oriana, et al.
Publicado: (2023)

The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway Approach
por: Nicotera, Giuseppe, et al.
Publicado: (2019)

An overview of Personalized Medicine landscape and policies in the European Union
por: Beccia, F, et al.
Publicado: (2022)

Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications
por: Lenić, Ines, et al.
Publicado: (2019)

Prevalence of potentially inappropriate prescribing in a subpopulation of older European clinical trial participants: a cross-sectional study
por: O Riordan, David, et al.
Publicado: (2018)

A Comparison of Reimbursement Recommendations by European HTA Agencies: Is There Opportunity for Further Alignment?
por: Allen, Nicola, et al.
Publicado: (2017)

Improving Risk Assessment in the European Food Safety Authority: Lessons From the European Medicines Agency
por: Chatzopoulou, Sevasti, et al.
Publicado: (2020)

European Medicines Agency Conflicts With the European Food Safety Authority (EFSA) on Bisphenol A Regulation
por: Zoeller, R Thomas, et al.
Publicado: (2023)

Mapping the teaching of honeybee veterinary medicine in the European Union and European Free Trade Area
por: Iatridou, Despoina, et al.
Publicado: (2019)

Pharmacogenetic‐Pharmacokinetic Interactions in Drug Marketing Authorization Applications via the European Medicines Agency Between 2014 and 2017
por: Maliepaard, Marc, et al.
Publicado: (2020)

Stratified medicine in practice: review of predictive biomarkers in European Medicines Agency (EMA) indications
por: Malottki, Kinga, et al.
Publicado: (2011)

Review: UK medicines likely to be affected by the proposed European Medicines Agency’s guidelines on phthalates
por: Jamieson, Lisa, et al.
Publicado: (2015)

Biomarker and Companion Diagnostics—A Review of Medicinal Products Approved by the European Medicines Agency
por: Orellana García, Laura Patricia, et al.
Publicado: (2021)

Consumption of cephalosporins in the community, European Union/European Economic Area, 1997–2017
por: Versporten, Ann, et al.
Publicado: (2021)

Consumption of quinolones in the community, European Union/European Economic Area, 1997–2017
por: Adriaenssens, Niels, et al.
Publicado: (2021)

Consumption of penicillins in the community, European Union/European Economic Area, 1997–2017
por: Bruyndonckx, Robin, et al.
Publicado: (2021)

Consumption of antibiotics in the community, European Union/European Economic Area, 1997–2017
por: Bruyndonckx, Robin, et al.
Publicado: (2021)

Nurse-led medicines’ monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the adverse drug reaction (ADRe) profile for mental health medicines
por: Jordan, Sue, et al.
Publicado: (2018)

EMEA and Gene Therapy Medicinal Products Development in the European Union
por: Papaluca Amati, Marisa, et al.
Publicado: (2003)

Use of biomarkers in the context of orphan medicines designation in the European Union
por: Tsigkos, Stelios, et al.
Publicado: (2014)

Improving the Safety of Medicines in the European Union: From Signals to Action
por: Potts, Joanne, et al.
Publicado: (2019)

Overview of the European Medicines Agency's Development of Product‐Specific Bioequivalence Guidelines
por: Sullivan, Jane O', et al.
Publicado: (2018)

Biomarker Qualification at the European Medicines Agency: A Look Under the Hood
por: Berman, Steven, et al.
Publicado: (2022)

Cannot write session to /tmp/vufind_sessions/sess_ss61pjl46rk67a2dna1cqefhef