WHO collaborative registration procedure using stringent regulatory authorities’ medicine evaluation: reliance in action?-Reference-Cited by-同舟云学术

WHO collaborative registration procedure using stringent regulatory authorities’ medicine evaluation: reliance in action?

Published:2022-01-02 Issue:1 Volume:15 Page:11-17
ISSN:1751-2433
Container-title:Expert Review of Clinical Pharmacology
language:en
Short-container-title:Expert Review of Clinical Pharmacology

Author:

Vaz Alexandra¹,Roldão Santos Mariana²,Gwaza Luther²,Mezquita González Elena¹,Pajewska Lewandowska Magdalena³,Azatyan Samvel²,Saint-Raymond Agnès¹

Affiliation:

1. International Affairs Division, European Medicines Agency, Amsterdam, Netherlands

2. Regulation and Prequalification Department [RPQ] World Health Organization, Geneve, Switzerland

3. International Collaboration, Urzad Rejestracji Produktow LecznIczych Wyrobow Medycznych I Produktow Biobojczych, Warszawa, Poland

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Pharmacology, Toxicology and Pharmaceutics,General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/17512433.2022.2037419

Reference13 articles.

1. World Health Organization. Assessment of medicines regulatory systems in sub-saharan African Countries. An Overview of Findings from 26 Assessment Reports; 2010. cited 2021 Jan 15]. Available from 2021 Jan 15: https://www.who.int/healthsystems/Assessment26African_countries.pdf

2. World Health Organization. WHO support for medicines regulatory harmonization in Africa: focus on East African Community. cited 2021 Jan 15]. Available from 2021 Jan 15: https://www.who.int/medicines/publications/druginformation/DI_28-1_Africa.pdf?ua=1

3. World Health Organization. Good reliance practices in the regulation of medical products: high level principles and considerations. cited 2021 Jun 29]. Available from 2021 Jun 29: https://www.who.int/publications/i/item/55th-report-of-the-who-expert-committee-on-specifications-for-pharmaceutical-preparations* Guideline describing the use of the concept of reliance

4. World Health Organization. Good regulatory practices in the regulation of medical products. cited 2021 Apr 16]. Available from 2021 Apr 16: https://www.who.int/publications/i/item/55th-report-of-the-who-expert-committee-on-specifications-for-pharmaceutical-preparations

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