6 Bibliography

A non exhaustive list of references and further reading materials related to SFMPs is provided here. It includes key WHO publications, peer-reviewed scientific literature, and other relevant resources that trainers can use to deepen their understanding of SFMPs and stay informed about the latest research and developments in the field.

General: Selected WHO guidance documents

• Annex 2 Good manufacturing practices for pharmaceutical products: main principles. In: Forty-eighth report of the WHO Expert Committee on specifications for pharmaceutical preparations. Geneva: World Health Organization; 2014 ( https://iris.who.int/handle/10665/337551, accessed 26 November 2024).
• Protecting the supply chain: reports on informal markets. In: Member State survey on informal markets and literature review on informal markets. Geneva: World Health Organization; 2023.
• Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics. Geneva: World Health Organization; 2021 (https://iris.who.int/handle/10665/337551, accessed 26 November 2024).
• Identification of reporting barriers faced by national focal points of the Global Focal Point Network and possible solutions. In: 12th Meeting of the Member State Mechanism on Substandard and Falsified Medical Products. Geneva: World Health Organization. 2023. (https://apps.who.int/gb/sf/pdf_files/MSM12/A_MSM12_5-en.pdf, accessed 12 December 2024).
• Rapid risk assessment of acute public health events. Geneva, World Health Organization, 2012 (https://iris.who.int/handle/10665/70810, accessed 12 December 2024).
• Quality assurance of medicines terminology database: list of terms and related guidelines [internet]. Geneva: World Health Organization; 2023 (https://www.who.int/publications/m/item/quality-assurance-of-medicines-terminology-database, accessed 17 November 2024).
• Annex 1: WHO good pharmacopoeial practices. In: Fiftieth report of the WHO Expert Committee on specifications for pharmaceutical preparations. Geneva: World Health Organization; 2016 (https://iris.who.int/handle/10665/255338, accessed 17 November 2024).
• Annex 4: WHO good practices for pharmaceutical quality control laboratories. In: Fifty seventh report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. Geneva: World Health Organization, 2024 (https://www.who.int/publications/m/item/who-good-practices-for-pharmaceutical-quality-control-laboratories, accessed 12 Dec 2024).

Module A. Background

WHO guidelines on use and regulation of pharmaceuticals

• A study on the public health and socioeconomic impact of substandard and falsified medical products. Geneva: World Health Organization; 2017 (https://iris.who.int/handle/10665/331690, accessed 26 November 2024).
• Annex 3. Model quality assurance system for procurement agencies. In: Forty-eighth report of the WHO Expert Committee on specifications for pharmaceutical preparations. Geneva: World Health Organization; 2014 (https://iris.who.int/handle/10665/112733, accessed 26 November 2024).
• Annex 3. Reporting form for complaints for medical devices including in vitro diagnostics. In: Report of Africa Medical Devices Forum COVID-19 Task Force. African Medical Device Forum; 2020 (https://www.afro.who.int/publications/report-africa-medical-devices-forum-covid-19-task-force, accessed 26 November 2024).
• Annex 5. Technical supplements to Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products. In: Forty-ninth report of the WHO Expert Committee on specifications for pharmaceutical preparations. Geneva: World Health Organization; 2011 (https://iris.who.int/handle/10665/176954, accessed 26 November 2024).
• Annex 5. WHO good distribution practices for pharmaceutical products. In: WHO Expert Committee on specifications for pharmaceutical preparations: forty-fourth report. Geneva: World Health Organization; 2010 (https://iris.who.int/handle/10665/44291, accessed 26 November 2024).
• Annex 5. Guidelines on import procedures for medical products. In: Fifty-third report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. Geneva: World Health Organization; 2019 (https://iris.who.int/handle/10665/312316, accessed 26 November 2024).
• Annex 8 Joint FIP/WHO Guidelines in good pharmacy practice: standards for quality of pharmacy services. In: Forty-fifth report of the WHO Expert Committee on specifications for pharmaceutical preparations. Geneva: World Health Organization; 2011 (https://iris.who.int/handle/10665/44079, accessed 26 November 2024).
• Annex 10. Good reliance practices in the regulation of medical products: high level principles and considerations. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-fifth report. Geneva: World Health Organization; 2021 (https://iris.who.int/handle/10665/340323, accessed 26 November 2024).
• Annex 11. Good regulatory practices in the regulation of medical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-fifth report. Geneva: World Health Organization; 2021 (https://iris.who.int/handle/10665/340323, accessed 26 November 2024).
• Combating substandard and falsified medical products. Geneva: Council for International Organizations of Medical Sciences; 2020 (https://cioms.ch/wp-content/uploads/2020/02/CIOMS-Special-Newsletter_WHO_SF_Meds_20Feb2020_Final.pdf, accessed 26 November 2024).
• Eighth meeting of the Members State Mechanism on substandard and falsified medical products. Problem statement identifying the range of issues that facilitate the sale and supply of substandard and falsified medical products through the internet both nationally and across borders. Geneva: World Health Organization; 2019 (https://apps.who.int/gb/SF/pdf_files/MSM8/A_MSM8_3-en.pdf, accessed 26 Nov 2024).
• Executive Board, 118. Rational use of medicines: progress in implementing the WHO medicines strategy: report by the Secretariat. Geneva: World Health Organization; 2006. (https://iris.who.int/handle/10665/21525, accessed 26 November 2024).
• Expert Committee on Specifications for Pharmaceutical Preparations: fifty-fifth report. Geneva: World Health Organization; 2021 (https://iris.who.int/handle/10665/340323, accessed 26 November 2024).
• Full list of WHO medical product alerts [internet]. Geneva: World Health Organization; 2024 (https://www.who.int/teams/regulation-prequalification/incidents-and-SF/full-list-of-who-medical-product-alerts, accessed 26 November 2024).
• Global surveillance and monitoring system for substandard and falsified medical products. Geneva: World Health Organization; 2017 (https://iris.who.int/handle/10665/326708, accessed 26 November 2024).
• Global competency framework for regulators of medicines. Geneva: World Health Organization; 2023 (https://iris.who.int/handle/10665/374053, accessed 26 November 2024).
• Global benchmarking tool (GBT) for evaluation of national regulatory system of medical products. Geneva: World Health Organization; 2023 (https://iris.who.int/handle/10665/376137, accessed 10 December 2024).
• Guidance for conducting quality surveys (Working Document QAS/15.630). Geneva: World Health Organization, 2015 (https://www.who.int/publications/m/item/qas-15.630, 10 December 2024).
• Guidelines for medicine donations, revised 2010. Geneva: World Health Organization; 2011 (https://iris.who.int/handle/10665/44647, accessed 26 November 2024).