Regulatory experience of handling Risk Management Plans (RMPs) for medicinal products in the EU-Reference-Cited by-同舟云学术

Regulatory experience of handling Risk Management Plans (RMPs) for medicinal products in the EU

Published:2021-04-22 Issue:7 Volume:20 Page:815-826
ISSN:1474-0338
Container-title:Expert Opinion on Drug Safety
language:en
Short-container-title:Expert Opinion on Drug Safety

Author:

Butler Dianne¹²,Vucic Katarina²,Straus Sabine²³,Cupelli Amelia²⁴,Micallef Benjamin¹²,Serracino-Inglott Anthony¹⁵,Borg John-Joseph¹²⁶

Affiliation:

1. Medicines Authority, San Ġwann, Malta

2. European Medicines Agency, Amsterdam, The Netherlands

3. Medicines Evaluation Board, Utrecht, The Netherlands

4. Italian Medicines Agency (AIFA), Rome, Italy

5. Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta

6. Department of Biology, University of Tor Vergata, Rome, Italy

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/14740338.2021.1909569

Reference52 articles.

1. European Medicines Agency. Authorisation of medicines [Internet]. The Netherlands: European Medicines Agency; [cited 2021 Feb 18]. Available from: https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines

2. European Union pharmacovigilance capabilities: potential for the new legislation

3. Health Canada. Guidance document - submission of risk management plans and follow-up commitments [Internet]. Ottawa (CA): Health Canada ; 2015[cited 2019 Dec 05]. Available from: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/pubs/medeff/guide/2015-risk-risques_management-gestion_plans/2015-risk-risques_management-gestion_plans-eng.pdf

4. European Medicines Agency and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP) Module V – risk management systems (Rev 2) - EMA/838713/2011. London (UK): European Medicines Agency; 2017 Mar 28. [cited 2021 Feb 18]. Available from https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-v-risk-management-systems-rev-2_en.pdf

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