Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic

Dehaghi, Razieh Ostad Ali; Khadem Broojerdi, Alireza; Paganini, Lodovico; Sillo, Hiiti B.

doi:10.3389/fmed.2023.1173291

Cited by 3 publications

(1 citation statement)

References 33 publications

(74 reference statements)

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“…It is interesting that the WHO databases contain data on the results of formal or independent diagnostics of regulatory systems in the field of circulation of medicinal products. Most of the countries participating in the study represented the Asian or African continents [34,35]. In Ukraine, a similar study using the WHO methodology "Global Comparison Tool" is being conducted for the first time.…”

Section: Discussion Of Research Resultsmentioning

confidence: 99%

Results of the expert survey assessing the efficiency level of the national regulatory system in the field of medicines turnover

Suvorov,

Kotvitska

2023

SR: PS

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The aim. The aim of the research is to analyze the efficiency level of the national regulatory system in the field of medicines circulation using self-diagnostic tools, which will allow identifying reserves for its optimization and further improvement. Materials and methods. The research materials consisted of the results of a survey conducted among government officials of national regulatory authorities in the field of medicines circulation. The research utilized methods of sociological survey, descriptive statistics, graphical analysis, data grouping, and generalization techniques. The research includes the development of a questionnaire based on the World Health Organization's "Global Benchmarking Tool" methodology, adapted to the national healthcare system. The questionnaire consisted of 2 questions to determine respondent characteristics and 104 statements about the functioning of the national regulatory system in the field of drug circulation. Results. According to 75 % of the surveyed officials in Ukraine, an effective regulatory system operates in the field of drug circulation. Based on the number of affirmative answers, all statements were divided into 4 groups: high, sufficient, moderate, and low. Thus, the quality management system of national regulatory authorities was evaluated at a high level, while the funding system of national regulatory authorities received the lowest ratings. The grouping allowed us to identify weaknesses in the activity of the national regulatory system in the field of drug circulation, such as the lack of funds in budgets for staff training and overall insufficient funding for national regulators, including insufficient funding from international donors, lack of clarity and comprehensiveness in the regulatory framework for the pharmaceutical sector, etc. Conclusions. In accordance with the aim of the article, we conducted research on the efficiency level of the national regulatory system in the field of drug circulation, which revealed that the most mature and effective direction of its activity today is the development and implementation of quality systems in national regulatory authorities

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Section: Discussion Of Research Resultsmentioning

confidence: 99%

Results of the expert survey assessing the efficiency level of the national regulatory system in the field of medicines turnover

Suvorov,

Kotvitska

2023

SR: PS

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Improving access to medicines to reduce marketing and use of substandard and falsified medicines in Africa: Scoping review

Sorato,

Davari,

Kebriaeezadeh

2024

The Journal of Medicine Access

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Background: Both constrained access to essential medicines and combatting marketing of substandard and falsified (SF) medicines are unmet health sector goals in Africa. Objective: To answer the question of how improved access can reduce the continuous surge of SF medicines in Africa. Design: We conducted a scoping review based on standard protocol. Methods: We searched articles published in the English language from PubMed/Medline, Cochrane Library, Embase, Scopus, Web of Science, and Google Scholar by using a systematic search query. Results: Seventy-one articles were included in this review. Access to quality essential medicines is still a major problem in developing countries in Africa and will continue as a threat for the next decade of health care. Ensuring access to quality medicines and preventing SF medicines in Africa need a systematic approach to address their underlying causes. Failure to ensure access to medicines is the major reason for the availability of SF medicines. Improving access to quality medicines can reduce SF medicine marketing and use. Manipulating the entire supply chain for efficiency, avoiding trade agreements that could reduce access, using compulsory licensing provisions, and pharmaceutical price control, providing incentives for drug development, and promoting rational use of medicines can improve access. Conclusion: Ensuring access to medicines and preventing SF medicine marketing cannot be achieved in the planned period in developing countries in Africa unless a comprehensive strategy is used. Improving access to quality medicines can reduce SF medicine marketing and use, that is, ensuring access through uninterrupted supply, improved efficiency, enhanced local production, preventing SF medicine entry, improved medication use system, and improved affordability. Therefore, it is essential to improve supply chain capability, address challenges of the supply chain, improve leadership and governance, establish country-specific anti-counterfeiting and anti-substandardization committees, and collaborate with all relevant stakeholders.

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WHO-listed authorities (WLA) framework: transparent evidence-based approach for promoting regulatory reliance towards increased access to quality-assured medical products

Broojerdi,

Salvati,

Abdelfattah

et al. 2024

Front. Med.

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BackgroundIncreased global access to safe, effective and quality-assured medical products remains a primary goal for the full realization of the World Health Assembly Resolution WHA 67.20 on regulatory systems strengthening for medical products as well as target 3.8 of the Sustainable Development Goals (SDG). To promote the development of efficient regulatory systems, the WHO introduced the Global Benchmarking Tool (GBT) in 2016, upon which the WHO–Listed Authority (WLA) framework was later established. This study aimed to appraise the development of the WLA framework across various phases while highlighting its achievements, challenges, and areas for improvement.MethodsAn exploratory study design using a qualitative approach was used to gather information from relevant documents as well as views and experiences from purposefully selected participants from diverse backgrounds. Data was collected using a combination of desk reviews and In-depth one-to-one or small group interviews employing semi-structured interview guides with open-ended questions. Data was analysed using an inductive thematic analysis approach.ResultsThe leading role of the WHO was noted in developing and implementing essential documents and mediating consultative processes among stakeholders. The framework was revealed to bring an evidence-based, inclusive, and transparent approach to recognizing regulatory authorities (RAs) operating at the highest standards of performance. The framework was anticipated to promote regulatory reliance among all RAs, the WHO’s prequalification programme, and procurement agencies. Furthermore, remarkable progress towards WLA listing was noted among transitional WLAs including the Stringent Regulatory Authorities (SRAs). Challenges related to the availability of resources, resistance to change, and complexity were associated with the framework.ConclusionThe study provides a well-rounded view with regard to the roles of the WHO, Member States and other stakeholders in establishing and operationalizing the WLA framework. Furthermore, evaluating the performance and possible WLA designation of RAs operating at international regulatory standards underscores its high relevance in contributing to public health globally. Maintenance along with timely addressing of highlighted next steps to improve the framework particularly in creating better understanding, more communication, and coordination are highly encouraged.

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Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic

Cited by 3 publications

References 33 publications

Results of the expert survey assessing the efficiency level of the national regulatory system in the field of medicines turnover

Results of the expert survey assessing the efficiency level of the national regulatory system in the field of medicines turnover

Improving access to medicines to reduce marketing and use of substandard and falsified medicines in Africa: Scoping review

WHO-listed authorities (WLA) framework: transparent evidence-based approach for promoting regulatory reliance towards increased access to quality-assured medical products

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