National Regulatory Authorities Research Articles

The role of regulatory agencies within health systems during emergencies in BrazilPapel de los organismos regulatorios en los sistemas de salud en situaciones de emergencia en Brasil

The performance of health systems is related to ensuring the right to health, an important component of human rights that includes the right to health protection. Regulatory action by the state aims to reduce risks to health and thus help improve health system performance, particularly with respect to the principles of comprehensiveness and equity. The aim of this article is to discuss resilience from the perspective of national regulatory agencies - especially when they are faced with public health emergencies (PHEs) - and their contribution to health system resilience, taking as a model the work of the Brazilian Health Regulatory Agency (ANVISA). In the context of PHEs, health regulators have been improving their practices and working on several fronts. Regulatory agencies have used specific regulatory instruments to speed up access to effective and safe products for responding to pandemics, to ensure the quality of care, and to communicate with the public. ANVISA specifically has brought new areas of action under its purview, such as overseeing the development of mechanical ventilators. It is crucial to recognize the interdependence between improving response capacity and improving performance in dealing with PHEs. Examples include the fast-track approval of COVID-19 vaccines, which allowed more rapid vaccination; cooperation among regulatory agencies; and, in the case of Brazil, work by ANVISA to strengthen the role of the country's Unified Health System (SUS) and the right to health in the face of disinformation and denialism.

Advancements in regulatory agility, regional collaboration, and digital transformation: insights from the Asia Partnership Conference of Pharmaceutical Associations (APAC)

PurposeThe Asia Partnership Conference of Pharmaceutical Associations (APAC) examines recent developments in regulatory practices across Asia, focusing on regulatory agility, regional collaboration, and digital transformation. The paper identifies key improvements made by national regulatory authorities (NRAs) in adopting regulatory agilities over a two-year span. It also suggests optimizing regional reliance pathways and recommends best practices for implementing e-submission, real-world evidence (RWE), decentralized clinical trials (DCTs), and paperless e-labelling.MethodsAPAC surveyed all 14 member associations to track progress in regulatory agility implemented by our NRAs from 2022 through April 2024. Additionally, APAC assessed the uptake of regional reliance pathways and the implementation levels of e-submission, RWE, DCTs, and paperless e-labelling. Through the analysis of case studies and survey results, the paper aims to identify key trends, challenges, and opportunities in the regulatory landscape.ResultsNine of twelve NRAs have advanced in regulatory agility, with Thai FDA leading with a 36% improvement and ranking 7th in the number of best practices implemented. e-Labeling adoption rose by 50%, and there was a 17% increase in the use of multiple sites under one license, good reliance practices, and acceptance of electronic Certificates of Pharmaceutical Product (eCPP) and Good Manufacturing Practice (eGMP). Perceived issues with the ASEAN Joint Assessment (JA) procedure include timeline constraints, limited flexibility in choosing participating NRAs, and country-specific requirements. NRAs have achieved 100% adoption of e-submissions and 50% for paperless e-labeling. Additionally, 67% accept data from DCTs and RWE using good reliance practices. However, 42% still require paper documents in e-submissions, and 50% continue to accept dossier format different from the International Council for Harmonisation Electronic Common Technical Document (ICH CTD).ConclusionsAPAC supports adopting agility best practices to reduce country-specific requirements, optimizing the ASEAN JA procedure. APAC also values strategic partnerships with NRAs, as demonstrated by the case studies of Vietnam and India. The shift towards digital transformation is evident, with 50% adoption of paperless e-labeling and 100% adoption of e-submissions, though not all processes are paperless with the use of ICH CTD dossier format. Overall, continued alignment with international standards for implementing eCTD, RWE, and DCTs is required in all 12 economies to realize the full benefits of globally harmonized digital advancement.

Tackling the Burden of Substandard and Falsified Medicines and Health Technologies in Somaliland and Somalia

Background: The problem posed by the substandard and falsified (SF) medicines is a rising global challenge. WHO estimates that sales of SF medical products in low- and middle-income countries is around US$ 30 billion whereby 1 in 10 medical is substandard or falsified. Objectives: The purpose of this article was to enlighten the actions by the Somali NRA to tackle the scourge of SF medicines in Somalia. Methods: The literature was reviewed on the topic and evidence from other sources were incorporated including reports of post-marketing surveillance surveys, assessments at national and regional levels, as well as author’s experiences. Findings: The medicines regulatory capacity is weak in Somaliland and Somalia, where only 16% of total indicators for the regulatory system was in place as per WHO/IGAD rapid benchmarking of the National Regulatory Authority (NRA) in 2017, increasing the risk of circulation of SF medicines in the local private sector dominated and exclusively import relied pharmaceutical supply chain. Key actions by the NRA to address this problem include: regulatory reliance mechanisms such as using the WHO PQ/EUL for emergency authorization of vaccines, i.e. COVID-19 vaccines, enhanced licensing procedures, information exchange with NRAs in the region as well as technical collaboration with WHO. Conclusion & Recommendation: However, a lot has to be done and considering the weak laboratory capacity and the porous national borders, the risk of local circulation of SF medicines is high and swift actions are needed to ensure access to safe and quality medicines and health technologies in Somaliland and Somalia.

Research on Methods for Developing Software Identification Codes in Automotive Software Update Management Regulations

As vehicles become increasingly digitized and intelligent, with growing demands for functional iterations, software updates (OTA) are becoming more frequent. National regulatory agencies have taken corresponding measures to address the risks associated with automotive software updates. To enhance the automotive industry's standards and maintaina healthy industry ecosystem, it is urgent to establish requirements for managing software identification codes and tracking software changes. Current software update management documents, primarily the UN R156 regulation and the forthcoming GB "General Technical Requirements for Automotive Software Updates," specify requirements for software identification codes. Based on the UN R156 regulation and research on existing automotive code systems in China, we propose ideas and methods for developing software identification codes.

Analysis of historical data to accelerate deletion of Abnormal Toxicity Test requirement for biologicals and vaccines

Abnormal Toxicity Test (ATT) is performed as quality control test by manufacturers and National Control Laboratory (NCL) to ensure safety of biologicals. However, stakeholders are in general consensus that extraneous toxic contaminations are extremely unlikely where Good Manufacturing Practices (GMPs) and consistent production have been established. This test requiring mice and guinea pigs is still a regulatory requirement for the batch release of biologicals in several countries although it has been deleted by some National Regulatory Authorities (NRAs) and Pharmacopoeias while some are still working on its elimination. Therefore, ten years historic data of ATT performed at National Institute of Biologicals (NIB), India on 4813 batches of biologicals including blood and related products, enzymes, hormones and vaccines by using 33637 animals was analyzed. As per Indian Pharmacopeia (IP), 4783 batches of these biologicals passed the test. The test had to be repeated in 30 batches, all of which were blood products and the repetition rate was 0.62 %. Further, after repeat testing, all these 30 batches also passed the test. This data will help the regulatory authorities of countries where ATT is still a requirement, take appropriate decision regarding its deletion. The elimination of ATT from specific monographs of these biologicals will help save many thousands of animals being used globally for this test.

Measles-Rubella Microarray Patches Phase III Clinical Trial Framework: Proposal and Considerations.

Background: The Measles-Rubella Microarray Patch (MR-MAP) is an important technology that is expected to reduce coverage and equity gaps for measles-containing vaccines (MCVs), reach zero-dose children, and contribute to elimination of measles and rubella. MR-MAPs are anticipated to be easier to deploy programmatically and could be delivered by lesser-trained health workers, thereby increasing immunization coverage. The most advanced MR-MAP has reached clinical proof-of-concept through a Phase I/II trial in the target population of infants and young children. The World Health Organization (WHO) and partners have developed the Phase III clinical trial framework for MR-MAPs presented in this article. Objectives and Methods: The purpose of such framework is to inform the considerations, design and approach for the pivotal clinical trial design, while considering the anticipated data requirements to inform regulatory approval, WHO prequalification, and policy decision. Results: The proposed Phase III trial would compare the immunogenicity and safety of an MR-MAP with MR vaccine delivered subcutaneously in 9- to 10-month-old infants. An analysis of non-inferiority (NI) of immunogenicity would occur six weeks after the first dose. Should regulatory agencies or policy makers require, a proportion of infants could receive a second dose of either the same or alternate MR vaccine presentation six months after the first dose, with those children returning six weeks after the second dose for a descriptive assessment of immunogenicity, and then followed up six months after the second dose for evaluation of safety and immunogenicity. It is anticipated that this proposed pivotal Phase III trial framework would generate the required clinical data for regulatory licensure and WHO prequalification (PQ) of MR-MAPs. However, the trial design would need to be reviewed and confirmed by a national regulatory authority (NRA) that will assess the product for regulatory licensure and the WHO PQ team. Additional research will likely be required to generate data on concomitant vaccine delivery, the safety and immunogenicity of MR-MAPs in other age groups such as children 1-5 years and infants younger than 9 months of age, and the impact of MR-MAPs on coverage and equity. Such studies could be conducted during or after clinical MR-MAP development.

Deprescribing oral antidiabetics in elderly patients: Do electronic leaflets across the world address it?

Diabetes caused 6.7 million deaths in 2021, equating to one death every five seconds, with its global financial burden projected to rise from $1.32 trillion in 2015 to $2.12 trillion by 2030. Severe hypoglycemia necessitates interventions like deprescribing, behavioral strategies, and technology for prevention. Deprescribing aims to reduce unnecessary medication use, enhance rational prescribing, prevent prescribing cascades, and improve health outcomes in elderly patients. Evaluating electronic leaflets can support deprescribing based on patient-centered care and shared decision-making. ObjectiveTo analyze information on deprescribing in oral antidiabetic leaflets from national medicines regulatory authorities, focusing on elderly patients with type 2 diabetes. MethodsThis documental study analyzed electronic leaflets of oral antidiabetics from the official websites of nine Medicines Regulatory Authorities: Australia, Brazil, Canada, New Zealand, Singapore, South Africa, UK, USA, and EU, covering drugs listed in the WHO's Essential Medicines List 2023. The analysis focused on the alignment of deprescribing information with the Ontario deprescribing algorithm for oral antidiabetics developed by the Bruyère Institute in Canada. ResultsOut of 72 expected leaflets, 64 (88.9 %) were retrieved. Only 18 leaflets (28.1 %) explicitly discussed deprescribing oral antihyperglycemics. Hypoglycemia and drug interaction risks were addressed in 55 leaflets (85.9 %). Caution for use in patients over 65 was mentioned in 32 leaflets (50 %), and 23 leaflets (35.9 %) addressed the risks of tight glucose and HbA1c targets. ConclusionDespite a high retrieval rate, 11.1 % of leaflets were missing, and those available contained inconsistent deprescribing information. There are significant disparities in guidance across regulatory authorities. Standardized, updated leaflets that address deprescribing in frail older patients could enhance prescribers' confidence and support shared decision-making

Traceability for strengthening supply chain systems and enhancing real-time visibility: Focus of NAFDAC on advancing vaccine traceability in Nigeria

This study explores the successful implementation of activities aimed at scaling traceability for COVID-19 and routine immunization (RI) vaccines to the local government area and selected healthcare facilities in Nigeria, funded by the Bill and Melinda Gates Foundation. The study was executed by the National Agency for Food and Drug Administration and Control (NAFDAC) and sought to enhance supply chain systems by deploying advanced traceability mechanisms and ensuring real-time stock visibility. The article discusses the accomplishments, challenges, and regulatory framework of NAFDAC, emphasizing GS1 technology-driven traceability, and presents the results of the field scanning activities conducted in July 2023. The approach involved a phased public sector pilot, showcasing the feasibility and challenges of tracking vaccine movement through the supply chain. The result shows the detection of 43 unique products across 1022 facilities from a total of 110,113 scans, offering valuable insights into vaccine distributions. The strategic goals of the project aligned with developing safety surveillance systems in low- and middle-income countries (LMICs) to facilitate patient access to global health products. Similarly, significant improvement in traceability through automated data capture (barcode scanning) and expanded coverage for COVID-19 and selected RI vaccines in Nigeria was found. Against this background, the information derived from this report will build confidence in patients regarding vaccine authenticity, establish a transparent and robust supply chain, and foster pharmacovigilance capability through integration with the track-and-trace systems. Thus, the study provides invaluable insights and opportunities for global health practitioners, policymakers, and researchers to incorporate track-and-trace into regulatory systems by other national regulatory authorities.

Navigating investigator-initiated clinical trials: A call for guidelines & monitoring frameworks from an Indian context.

Investigator-initiated clinical trials - also known as non-regulatory or academic clinical trials, are conducted by investigators from academia or research organizations. They usually aim to address scientific questions with insufficient commercial implications and generate real-world applicable solutions, unlike trials sponsored by the pharmaceutical industry which are primarily focused on marketing approval of products that have a commercial value. For the trial results to be credible, adhering to robust methodology and the highest quality standards is paramount. Currently, investigator-initiated clinical trials in India are beyond the purview of the national regulatory authority. They are guided mainly by the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017 published by Indian Council of Medical Research. They lack an accepted framework for review, conduct, monitoring, reporting of adverse events, and participant compensation. Considering this scenario, we discuss the challenges faced in an investigator initiated clinical trial and explore plausible solutions.

Regulatory Quality in the International Circulation of Medicinal Products

Since 2014, the World Health Organization has been implementing a large-scale project to strengthen and develop national regulatory systems, which is aimed at increasing the availability of safe, effective and high-quality medicines and medical devices for the population of all countries, but primarily low- and middle-income countries. The project analyzes the maturity of national regulatory systems using a global benchmarking tool developed based on various regulatory authority assessment systems and has undergone extensive discussion and pilot testing; the results of national authorities that have reached high levels of maturity are published. A WHO List of Regulatory Authorities is also being formed, replacing the previously used concept of "stringent regulatory authorities". This List is recommended for use in regulatory reliance procedures by national regulatory authorities, purchasing structures of various levels and status: commercial, public, state or international. The regulatory quality of drug regulation is one of the critical factors of any national healthcare system. At the global level, it is directly related to goals 1,3,8,9 and 11 of sustainable development defined by the UN. The WHO project under consideration to assess maturity) of the regulatory system of the pharmaceutical sector is fundamentally different from similarly focused projects carried out in the past. First of all, the project focuses not on legal and regulatory/methodological documents, but on institutional and procedural aspects, i.e. on the structure and functions of regulatory bodies. Along with this, the project can have a significant impact on global pharmaceutical markets.

Current regulatory requirements for stability studies of biological medicinal products: a review

INTRODUCTION. The stability assessment of biological medicinal products (BMPs) requires special approaches and regulatory requirements. Therefore, BMPs require relevant national guidelines, which are an important prerequisite for the assurance of the safe and effective use of BMPs.AIM. This study aimed to analyse national and international requirements for the stability assessment of BMPs in order to use the results to inform future development of a unified regulatory approach to estimating and confirming shelf-life periods for BMPs.DISCUSSION. Most biotechnological medicinal products (BTMPs) are proteins and are highly sensitive to environmental factors by nature. Therefore, the shelf life of a BTMP is established on the basis of real-time stability studies. Stability testing under accelerated and stress conditions is conducted to support shelf-life claims and to characterise the mechanism of protein structure degradation. The results of accelerated and stress studies can be used to select the most sensitive stability-indicating parameters and testing methods. National and international regulatory authorities have developed specialised guidelines for stability studies of BMPs of various origins, and the stability assessment approaches in the regulatory system of the Eurasian Economic Union (EAEU) are harmonised with international standards. Special considerations associated with the stability of vaccines imply that stability studies of vaccines should not only establish shelf life but also investigate stability after reconstitution and after short-term temperature excursions from the recommended cold-chain conditions.CONCLUSIONS. Special stability testing considerations for various groups of BMPs (including BTMPs and immunobiologicals) indicate the need to develop and improve the system of requirements for BMP stability assessment. This will facilitate the optimisation of the life cycle of BMPs in the Russian Federation and the other EAEU member states.

Post closure safety assessment for near surface disposal

Near-surface facilities which are designed on or below the surface are typically used for Low Level Waste (LLW) and short-lived Intermediate Level Waste (ILW) disposal. Due to the site characteristics changes such as climate in the long-term period, a comprehensive disposal Safety Assessment (SA) is required to predict the future situation. The main aim of this paper is to make a safety assessment of a trench type near surface disposal facility in Iran based on ISAM methodology recommended by the International Atomic Energy Agency (IAEA). In such a manner, a surface water erosion, a shepherd, and a human intrusion are considered as design and alternative scenarios to model using AMBER code for a period of 100,000 years. Results presented; the maximum radiation is related to human intrusion scenario in which the total dose radiation reached to 0.3 mSv/y in the first year after the site passive institutional control. Moreover, the dose released from the investigated scenarios in the post-closure phase was less than 1 mSv/y, which is the IAEA regulatory body safety criteria. Comparison of the results showed that the current site is designed and constructed in accordance with safety guidelines which are established by the IAEA and Iran National Regulatory Authority (INRA).

True Benefits of Immune Checkpoint Inhibitors in the Treatment of Malignant Pleural Mesothelioma in Japan.

In February 2004, the Food and Drug Administration (FDA) was the first to approve the combination of cisplatin (CDDP) and pemetrexed (PEM) as standard first-line chemotherapy for untreated, unresectable malignant pleural mesothelioma (MPM). However, after that approval, no progress was made in the standard first-line treatment of MPM for almost 15 years. Positive results from a phase 3 study (Mesothelioma Avastin Cisplatin Pemetrexed Study: MAPS) verifying the effect of bevacizumab, an anti-angiogenesis agent added to CDDP/PEM for unresectable MPM, were published in The Lancet in December 2015; however, this did not lead to approval by national drug regulatory agencies. Furthermore, no second-line treatment was established for cases refractory to CDDP/PEM. In August 2018, the Pharmaceuticals and Medical Devices Agency of Japan was the first in the world to approve monotherapy with nivolumab, an immune checkpoint inhibitor (ICI), for previously unresectable, advanced, or recurrent MPM. Following Japan, in October 2020, the FDA approved the combination of nivolumab and ipilimumab for the treatment of previously untreated, unresectable MPM. In this article, we review the transition of drug treatment for MPM, in light of the historical background, focusing on the benefits of ICIs.

A Review on Pharmaceutical Regulatory Authority of India, USA, UK, Australia

Medicines play an important role in saving lives, maintaining health, preventing disease, curbing epidemics and promoting national economic development. This is why people, governments, the pharmaceutical industry and research institutes pay for drugs. However, to do this, the drugs must be safe, effective and of high quality. This means that the development, production, import, export and distribution of drugs are regulated to ensure that they meet prescribed standards. To effectively regulate medicines, the government has established strong National Regulatory Authorities (NRAs) to ensure that medicines are effectively regulated to protect and promote public health. Pharmaceutical regulations around the world play an important role in ensuring the safety, quality and efficacy of medicines. Medicines regulatory agencies are responsible for enforcing regulations and issuing guidelines for the development, licensing, registration, manufacture, labelling, storage, marketing, distribution, pricing of drugs, drug importation and post marketing studies. While seeking international markets, the pharmaceutical industry must comply with the pharmaceutical regulations of other countries with different regulatory requirements. A single regulatory approach for marketing authorization (MA) applications for medicines in different countries is difficult. Therefore, the Common Technical Document (CTD) was developed to provide a common format for the electronic submission of drug registration applications.

Evaluation of Drug and Herbal Medicinal Promotions on Social Media During the COVID-19 Pandemic in Relation to World Health Organization Ethical Criteria and South African Health Products Regulatory Authority Guidelines in South Africa: Cross-Sectional Content Analysis.

Consideration of ethics in the promotion of medications is essential to safeguard the health of consumers, particularly during health crises. The World Health Organization (WHO) and the South African Health Products Regulatory Authority (SAHPRA) have established stringent standards to ensure the integrity of pharmaceutical promotions and safeguard public health, including advertisements on the internet and social media platforms. However, the dynamic nature of online advertising poses challenges for monitoring and enforcing ethical standards. The study aimed (1) to examine the COVID-19 drug and medicinal promotions across online platforms and social media from 2020 to 2022 in South Africa and (2) to ensure that drug promotions adhere to ethical guidelines outlined by the WHO and SAPHRA. A cross-sectional content analysis was conducted to assess drug and medicinal advertisements across various internet and social media platforms. A systematic approach was used to identify and analyze promotional content, focusing on adherence to ethical guidelines outlined by WHO and SAPHRA. Data were collected and analyzed to determine the extent of compliance and identify any potential violations or areas for improvement. A total of 14 online drug advertisements were included in this analysis. Our findings show that most of the drugs advertised did not meet the regulations and guidelines provided by WHO and SAHPRA. There were omissions about active ingredients, proprietary names, adverse drug responses, precautions, and overdosage and adverse drug reactions. Traditional medicines were not fully consistent with the approved WHO ethical criteria data sheet. Our analysis highlights the critical importance of ensuring compliance with ethical guidelines in drug promotions on the internet and social media platforms. There is a need for continued vigilance and enforcement efforts to uphold ethical standards and protect the health of the public. Ongoing monitoring and collaboration between national drug regulatory agencies, pharmaceutical companies, and online platforms will be essential for promoting responsible advertising. In addition, safety monitoring and pharmacovigilance systems for herbal medicinal products are yet to be established.

Evaluation of the review models and approval timelines of authorities participating in the East African Medicine Regulatory Harmonisation initiative: alignment and strategies for moving forward.

Medicines regulatory harmonisation has been embraced by many national regulatory authorities (NRAs) to improve public health through faster availability of safe, high-quality, and effective medical products to patients and enhanced standardisation of technical guidelines and work sharing, leading to reduced cost to pharmaceutical companies. After ten years of implementing regulatory harmonisation by the East African Community Medicines Registration Harmonization (EAC-MRH) initiative, it is now imperative for participating NRAs to rely on each other to minimise duplication of use of limited resources. Major challenges in implementing reliance are the lack of clear registration processes and delays in the approval. The aim of this study was to compare review models, target timelines and data requirements used in assessing applications by EAC-MRH NRAs so as to align and propose strategies for improvement. A validated questionnaire that standardises and captures review processes was completed by the head of the medicine's registration division in each of the seven EAC-MRH NRAs. A country report based on the completed questionnaire was developed for each NRA and validated by the heads of the respective authorities. Most applications received by all countries were for generics except Kenya, which received a significant number of new active substance applications (55 and 53 in 2020 and 2021). Mean approval times for generics using full review varied, with Tanzania's time declining for the three years. Target timelines for full review for the five countries ranged between 180 calendar days (Tanzania) to the highest 330 days (Zanzibar). The three countries (Kenya, Rwanda and Uganda) utilising the verification review model had a target timeline of 90 days. All six authorities conducted abridged reviews and fast-track assessments through a priority review track. The common technical document format was mandatory for applications in all authorities. The target timeline for key milestones in the review process varied for each country with a few similarities. The study has provided a baseline for review models, target timelines and data requirements utilised in assessing applications for registration by EAC-MRH NRAs. Implementing the recommendations from this study will enable the NRAs to align and improve their registration processes.

Legitimacy considerations in regulation for local mobile communication network business in Finland and the UK

The article explores the legitimacy of local 5G and upcoming 6G mobile communication networks in Europe. The paper paves the way for a new perspective for understanding the legitimacy of local 5G/6G mobile communication networks by applying the business model-based ecosystem perspective and legitimacy as a theoretical foundation. As regulations are expanding to consider the novel deployment model of local 5G and 6G mobile communication networks, the legitimacy of such networks is under-explored. Analyzing the regulatory approaches taken by two national regulatory authorities (NRA) in Europe, Finland and the UK, we identify seven legitimacy-related themes including innovation orientation, awareness and knowledge of how to build and design local networks, European harmonized spectrum management, competition, cybersecurity and risk assessment and equipment availability. Our study lays the groundwork for exploring how the application of the business model-based ecosystem perspective can be utilized to advance regulatory initiatives for local mobile communication network businesses. It also identifies which legitimacy-related aspects are involved in setting regulatory priorities.

Short-Term Training, a Useful Approach for Sustainable Pharmacovigilance Knowledge Development in Tanzania, Kenya, Ethiopia and Rwanda.

Continuous professional development among stakeholders involved in drug safety monitoring and surveillance is imperative in strengthening pharmacovigilance (PV) systems. The "Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa" (PROFORMA) project aims to enhance the national PV infrastructure, post-marketing surveillance systems and clinical trial regulatory capabilities in Ethiopia, Tanzania, Kenya and Rwanda. To achieve this, training, including short-term training (STT) activities, at various levels is required. This article aims to describe the experiences of the authors during the development and implementation of STT in an attempt to improve the PV training landscape of these countries. To identify gaps, a baseline assessment of PV teaching and practices at the national medicines regulatory authorities (NMRAs) and medical universities was conducted. Five successive training sessions, tailored to each country's specific needs and regulatory environments, were conducted; three focusing on fundamental concepts in PV and two dedicated to training-of-trainers courses. The training targeted staff from PV units of the NMRAs and medical universities. Enabling participation from all four countries in the same training fostered cross-country learning and collaboration. The contribution of STT to university education and the operational methodologies within NMRAs are explored, showcasing the impact on knowledge transfer and skill development in each country. In conclusion, by investing strategically in STT activities and fostering partnerships with academic institutions and NMRAs, we demonstrated a sustainable approach to PV capacity strengthening in resource-limited settings. The success of this model underscores its potential for adoption and replication across the African continent, offering a valuable framework for strengthening drug safety regulation and ultimately protecting public health.

Post-marketing quality surveillance of selected antibacterial agents marketed in porous borders; the case of Ethiopia-Sudan-Eritrea border.

The presence of poor-quality medicines is becoming a public health threat in many parts of the world, particularly in developing countries. Antibiotics are among the most common anti-infective medicines that are highly prone to this problem. The purpose of this study was to assess the quality of selected antibacterials that are marketed in Setit Humera and West Gondar Zones, North West Ethiopia, which are located on the Ethiopian side of the Ethiopia-Sudan-Eritrea border. Seventy-one samples of the four antibacterial medicines (Ciprofloxacin, Norfloxacin, Amoxycillin, and Amoxycillin clavullanate combination) were collected from six sites in Setit Humera and West Gondar Zones, North West Ethiopia. A mystery shopping system was used for sample collection. Visual inspections and confirmation of the registration status were carried out using the joint WHO/FIP/USP checklist and the Ethiopian Food and Drug Authority's (EFDA's) Electronic Regulatory Information System (eRIS), respectively. Then Pharmacopeial methods (USP, BP) were employed to assess the physicochemical quality parameters. During the period of our data collection, the application status for registration in the eRIS system was checked. From 71 samples, 25.35% (18/71) were not registered, and 15.49% (11/71) were registered, but the license period had expired. Some samples (12.06% (17/71)) did not meet the visual inspection criteria. The physicochemical evaluation showed that all the samples studied met the quality specifications for the identification and hardness tests. However, concerning assay, dissolution, uniformity of dosage units, disintegration, and friability test parameters, 27.49% (23/71), 16.9% (12/71), and 14.08% (10/71), 2.82% (2/71) and 8.57% (3/35) of samples were found to be substandard, respectively. Overall, 56.33% (40/71) of the samples tested were of poor quality, failing to meet any one or more of the assessed parameters in this study. The study indicated that poor-quality antibacterial medicines are circulating in the study sites. Therefore, even if the area was affected by conflict at the time of the study, the regulatory bodies should focus on enforcing the necessary measures by collaborating with the regional and national regulatory medicine agencies to ensure that the antibacterial medicines available meet the required mandatory minimum standards.

Capacity Assessment of the National Medicines Regulatory Authority in a Low -Income Country.

Access to medical products of the required efficacy, quality and safety is essential for everyone's health and wellbeing. To achieve this milestone, every country needs a robust and strong performing National Regulatory Authority (NRA) that is independent and outcome oriented. With the help of the World Health Organization (WHO), the global benchmarking tool is the gold standard used to assess the regulatory capacity of NRAs. This study assessed the capacity of the National Medicines Regulatory Authority in Sierra Leone to perform its regulatory functions. This descriptive cross-sectional study used both qualitative and quantitative approaches. A self-administered questionnaire was used for the quantitative approach, and the qualitative aspect consisted of a desk review looking at key regulatory documents such as laws, regulations, policies, guidelines, standard operating procedures and reports. The data collection tool used was the WHO global benchmarking tool (GBT) for "Evaluation of National Regulatory System of Medical Product Version VI. The majority of the participants had a postgraduate degree (60%), and 72% had over 10 years of experience working at the NRA. Out of 251 sub-indicators assessed, 85 (34%) sub-indicators were fully implemented. Of the eight (8) functions assessed, sub-indicators related to clinical trial oversight and vigilance were the most implemented, with 67% and 62%, respectively. Of the 9 indicators assessed, 79% of the sub-indicators that are related to quality and risk management were implemented. The results of this study showed that PBSL operates at maturity level 1. The absence of laws and regulations that give PBSL the mandate to perform its regulatory functions was a major challenge even though other indicators were met. The study reported other challenges toward effective functioning, including but not limited to a lack of sufficient staff, weak enforcement of the sale of medicines and a poorly equipped quality control laboratory.