Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities

Author:

McAuslane Neil,Bujar Magda,Sithole Tariro,Ngum Nancy,Owusu-Asante Mercy,Walker StuartORCID

Funder

Bill and Melinda Gates Foundation

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference22 articles.

1. Ndomondo-Sigonda M, Miot J, Naidoo S, et al. Medicines regulation in Africa: current state and opportunities. Pharm Med. 2017;31:383–97. https://doi.org/10.1007/s40290-017-0210-x.

2. Ngum N, Mashingia J, Ndomondo-Sigonda M, Walker S, Salek S. Evaluation of the effectiveness and efficiency of the East African Community joint assessment procedure by member countries: the way forward. Front Pharmacol. 2022;13: 891506. https://doi.org/10.3389/fphar.2022.891506.

3. Sithole T, Mahlangu G, Walker S, Salek S. Regulatory authority evaluation of the effectiveness and efficiency of the ZaZiBoNa collaborative medicines registration initiative: the way forward. Front Med. 2022;9: 898743. https://doi.org/10.3389/fmed.2022.898743.

4. Azatyan S. Good reliance practice: accelerating access to quality-assured health products. Presented at the Centre for Innovation in Regulatory Science Workshop, Singapore, 27–28 March 2019. Available at: https://www.cirsci.org/publications/2019-workshop-report-optimising-the-regulatory-review-process-by-evaluating-performance-and-addressing-good-reliance-practices/. Accessed 14 Dec 2022.

5. World Health Organization. Good reliance practices in the regulation of medical products: high level principles and considerations Annex 10 in WHO Expert Committee on Specifications for Pharmaceutical preparations: fifty-fifth report. Geneva: World Health Organization; 2021 (WHO Technical Report Series, No. 1033). Available at: https://apps.who.int/iris/bitstream/handle/10665/340323/9789240020900-eng.pdf Accessed 14 Dec 2022.

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