Harmonization Initiative Research Articles

DEVELOPMENTS IN HARMONISATION OF SHARĪꜥAH AND LAW ON WAQF

Sharīꜥah-compliant social finance products are in high demand worldwide. Waqf is one of the above instruments based on which can be designed and implemented in line with Sharīꜥah. The complexities in Malaysia due to the adoption of the dual legal system, the federal-state background, and the exclusive jurisdiction of the state on Islamic matters have, to a certain extent, produced differences in procedures and laws, as well as in the area of waqf. This paper highlights the justification for, the processes related to, and developments in the harmonisation of waqf related laws in Malaysia, within the diverse legal background of the country. It adopts the method of doctrinal analysis, looking into various laws, articles, books, and research papers. The paper argues that harmonisation initiatives involving multiple fields, including law, policy, education, and strategic cooperation, are necessary to elevate waqf beyond the social philanthropy paradigm. It is found that the position of Islamic laws in Malaysia, to a certain extent, has impacted the development of waqf, especially in the jurisdictions of Sharīꜥah Court and civil court. The recognition of Islamic finance via specific laws has contributed to designing the framework of laws on waqf. History shows that a lack of understanding of the concept of waqf, especially related to its difference from the English concept of trust and the division of power between federal and state authorities, has also influenced the slow development of waqf in Malaysia. This paper recommends standardisation of state laws and a change of mindset among administrators, which are crucial for the sustainability of waqf in Malaysia. It is hoped that this study shall contribute to the preparation of new policies and laws especially in the Malaysian context.

Bridging big data in the ENIGMA consortium to combine non-equivalent cognitive measures

Investigators in neuroscience have turned to Big Data to address replication and reliability issues by increasing sample size. These efforts unveil new questions about how to integrate data across distinct sources and instruments. The goal of this study was to link scores across common auditory verbal learning tasks (AVLTs). This international secondary analysis aggregated multisite raw data for AVLTs across 53 studies totaling 10,505 individuals. Using the ComBat-GAM algorithm, we isolated and removed the component of memory scores associated with site effects while preserving instrumental effects. After adjustment, a continuous item response theory model used multiple memory items of varying difficulty to estimate each individual’s latent verbal learning ability on a single scale. Equivalent raw scores across AVLTs were then found by linking individuals through the ability scale. Harmonization reduced total cross-site score variance by 37% while preserving meaningful memory effects. Age had the largest impact on scores overall (− 11.4%), while race/ethnicity variable was not significant (p > 0.05). The resulting tools were validated on dually administered tests. The conversion tool is available online so researchers and clinicians can convert memory scores across instruments. This work demonstrates that global harmonization initiatives can address reproducibility challenges across the behavioral sciences.

Regional Approach to Boosting Local Pharmaceutical Manufacturing Capacity: A Critique of the East African Community Pharmaceutical Manufacturing Plan of Action

Abstract The East African Community (EAC) has had a chequered history, evidenced by multiple changes of names and objectives, and a hiatus lasting more than two decades following a collapse in 1977. It was resuscitated in 1999 by its founding members (Uganda, Tanzania, and Kenya). That four other partner states have since joined is a clear testament to the effectiveness of its overhaul. The community is regulated by the EAC Treaty which promotes collective actions in several areas of mutual interests. Plagued by an ongoing access-to-medicines conundrum, EAC governments have considered collective action as recommended by the Treaty. This effort began around the 2010s when policy measures aimed at exploring collective solutions were adopted with a view to replacing reliance on importation and external drug donation with a gradually developed regional pharmaceutical production capacity. EAC policies such as the Policy/Protocol on TRIPS Flexibilities, the Medicines Registration Harmonisation Initiative, the Draft Anti-Counterfeit Policy, and a Pharmaceutical Manufacturing Plan of Action (EAC PMP) have since been developed to achieve this ambitious goal. Using both doctrinal and empirical (semi-structured interviews) methods, this paper examines the EAC PMP – the ‘be all’ of the policies. The priority actions outlined under the plan’s six pillars and presented as a bankable pathway to self-sufficiency in pharmaceutical production are critiqued. The paper finds considerable implementation of the drug harmonisation theme, while the others (leveraging TRIPS flexibilities, ensuring coherence, and boosting research and development and technology transfer) remain largely unimplemented.

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.

The effect of balanced energy-protein supplementation provided to lactating women on maternal and infant outcomes: study protocol for a prospectively planned individual patient data (IPD) meta-analysis

Abstract* Background The high prevalence of infant stunting and maternal undernutrition in low- and middle-income countries poses a significant public health threat. The World Health Organization recommends balanced energy-protein (BEP) supplementation to pregnant women from populations with a high prevalence of underweight (prepregnancy BMI <18.5 kg/m2), leaving a notable gap in guidance for lactating women. Therefore, we established the Maternal BEP Studies Harmonization Initiative (BEP Initiative) to investigate the impact of BEP supplementation given to pregnant and/or lactating women on maternal and infant outcomes by synthesizing data from multiple clinical trials. This is a study protocol for our prospective individual participant data (IPD) meta-analysis on BEP lactation trials. Methods Data from four randomized controlled trials that include mother-infant dyads in India (n=816), Pakistan (n=957), Burkina Faso (n=800), and Nepal (n=726) will be pooled and analysed. Women were randomized to BEP (one trial had a third arm with maternal BEP plus infants receiving azithromycin) or control groups at baseline (during the first week) and received the intervention through six months postpartum. A one-stage IPD meta-analysis will be done using mixed-effects linear and log-binomial regression models to account for between-trial heterogeneity. The primary outcome of infant length-for-age z scores (LAZ) and secondary outcomes of maternal and infant indicators of nutritional status, all at six months of age, will be examined. Also, we will assess baseline characteristics as covariates and effect modifiers for the BEP to outcome relationship. Discussion This prospective IPD meta-analysis uses a one-stage IPD meta-analysis, which allows for higher statistical power to examine outcomes, more flexibility in defining variables, and can examine effect modifiers, which could inform which individuals or populations may benefit more from BEP given during lactation.

Prioritizing Patient Reported Outcome Measures (PROMs) to use in the clinical care of youth living with mental health concerns: a nominal group technique study

BackgroundIn the past few decades, particularly in the mental health setting, there has been growing interest in using Patient Reported Outcome Measures (PROMs) to assess the efficacy of the treatments in healthcare systems. Despite recent initiatives for global harmonization, there remains a lack of consensus on which PROMs are best practice and appropriate. Engagement of the service users, such as patients and family members/caregivers, is vital at this stage to ensure the selected PROMs are feasible, relevant, and acceptable to them. This study aimed to prioritize PROMs by youth and family/caregiver based on feasibility, relevance, and overall importance to be used in the clinical care of youth living with anxiety and/or depression.MethodsTen validated and widely used PROMs were presented to the patients and family/caregivers. Nominal group techniques were employed to prioritize the PROMs based on feasibility, relevance, and overall importance.ResultsFor patients and families/caregivers, the PROMs, Revised Child Anxiety and Depression Scale (RCAD 25), and The Young Person’s Core (YP-CORE) were the highest priorities. Both felt that RCAD 25 was comprehensive, short, easy, and quick to complete, whereas regarding YP-CORE, patients and family/caregivers thought it was also short and relevant. Due to some specific concerns, the Strength and Difficulties Questionnaire and Child Health Questionnaire were the lowest prioritized by patients and family/caregivers.ConclusionIt is of utmost importance that patient’s and family/caregivers’ voices or opinions are considered while selecting and implementing PROMs in mental health settings. Our study provides practical recommendations around measures best suited to achieve this.

Comparison of Three Regional Medicines Regulatory Harmonisation Initiatives in Africa: Opportunities for Improvement and Alignment.

The African Medicines Regulatory Harmonisation (AMRH) Initiative was formed in 2009 and subsequently, three regional initiatives (East African Community Medicines Regulatory Harmonisation [MRH], Southern African Development Community [SADC]/ZaZiBoNa MRH, and the Economic Community of West Africa States MRH) were established. As these initiatives serve as a foundation for the African Medicines Agency (AMA), the aim of this study was to compare their operating models, successes and challenges to identify opportunities for improvement and alignment. A mixed method approach was used for the data collection using a questionnaire, the Process, Effectiveness and Efficiency Rating (PEER), developed by the authors specifically for this study and semi-structured interview techniques. There were 23 study participants (one from each agency of the member countries of the three regions). It was hoped that data generated from this study would lead to a series of recommendations, which would then be ratified by the regulatory authorities. Most respondents stated that AMRH contributed to the strengthening of regulatory systems and harmonising regulatory requirements across economic regions of Africa, potentially resulting in improved access to quality-assured medicines. Although established at different times and at the discretion of each region, the marketing authorisation application review processes are largely similar, with a few differences noted in the eligibility and submission requirements, type of procedures employed, the timelines and fees payable. The challenges identified in the three regions are also similar, with the most noteworthy being the lack of a binding legal framework for regional approvals. In this study, we compared the process, successes and challenges of these three regional harmonisation initiatives in Africa addressing the areas of legal frameworks, information management systems, the accessibility and affordability of medicines and reliance that will bring greater alignment and efficiency in their operating models, thereby strengthening the foundation of the soon-to-be-operationalised AMA.

Evaluation of good review practices in member authorities of the East African Medicines Regulatory Harmonisation initiative: strategies for alignment with African medicines agency.

The East African Community Medicines Regulatory Harmonisation (EAC-MRH) programme was established to address challenges faced by national regulatory authorities (NRAs) of the region. Work sharing through joint assessments and inspections was adopted to manage limited resources and capacity; however, NRA good review practices (GrevP) are also a key determinant to success. This study evaluated GReVP among the EAC-MRH NRAs and mapped required strategies for countries to align themselves with the African Medicines Agency (AMA). A validated questionnaire (Optimising Efficiency in Regulatory Agency-OpERA) that standardises and captures review processes was completed by the head of the medicines registration division in each NRA. A country report based on the completed questionnaire was developed for each NRA and validated by the heads of the respective authorities. The population and size of the NRAs vary and four of the countries have semi-autonomous authorities and three NRAs are autonomous. The Burundi and South Sudan authorities were fully government funded, Kenya and Uganda entirely from fees, while Rwanda, Tanzania and Zanzibar were partially funded from different sources. All authorities except South Sudan, which does not receive or review applications had backlogs. Authority fees varied based on the different application categories. Key milestones for standardised regulatory processes are implemented in all authorities. Queue times range from a few weeks to about one year. Three NRAs use internal technical agency staff for scientific assessments and three use both internal and external experts. Clock stop time varies and target timelines for review committee range from one day to three months. All the NRAs implement some best practices on quality measures, transparency and communication. Some have activities for transparency improvement but with minimal attention to training and education. Most employ some quality decision-making practices. GrevP in EAC-MRH NRAs still needs to be improved and it is imperative that these authorities streamline and harmonise their practices. Increasing human resources and an investment in training and education of staff will enable the implementation of all measures for GRevP. This is vital, as the effectiveness and efficiency of the AMA will depend on the strength of these NRAs.

Advances and challenges in animal source food inspection legislation for Brazilian small-scale and artisanal producers.

The strict sanitary inspection legislation of animal source food has been considered a trade barrier for smallholder farmers and small-scale producers in Brazil. In this sense, law flexibilization is suggested to facilitate national trade of these products. We conducted a social and sanitary analysis, presenting the current Brazilian conjuncture and difficulties for animal source food Brazilian inspection law flexibilization. By discussing inequalities, human rights issues, animal source food legislation, and international food safety standards, we evidenced critical barriers for legislative reform in Brazil. Among these barriers, the main ones are social inequalities; high zoonotic risk of animal source food products; the Brazilian political structure and its reflection on different inspection practices among country jurisdictions; and the lack of inspection services in most Brazilian municipalities. At the same time, we present positive updates in the normative framework, and point out game-changers to modify the actual safety and trade situations of Brazilian small-scale and artisanal animal source food products, including policies to strengthen state and municipal inspection services and harmonization initiatives based on international standards and national legislation. We also suggest policies to implement inspection services in municipalities, whether by municipal action or by a consortium, as well as policies to strengthen technical assistance and rural extension for small-scale and artisanal producers. These policies aim to reduce technical and sanitary education inequalities and build a fairer animal source food system.

Public Preferences for Digital Health Data Sharing: Discrete Choice Experiment Study in 12 European Countries.

With new technologies, health data can be collected in a variety of different clinical, research, and public health contexts, and then can be used for a range of new purposes. Establishing the public's views about digital health data sharing is essential for policy makers to develop effective harmonization initiatives for digital health data governance at the European level. This study investigated public preferences for digital health data sharing. A discrete choice experiment survey was administered to a sample of European residents in 12 European countries (Austria, Denmark, France, Germany, Iceland, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom) from August 2020 to August 2021. Respondents answered whether hypothetical situations of data sharing were acceptable for them. Each hypothetical scenario was defined by 5 attributes ("data collector," "data user," "reason for data use," "information on data sharing and consent," and "availability of review process"), which had 3 to 4 attribute levels each. A latent class model was run across the whole data set and separately for different European regions (Northern, Central, and Southern Europe). Attribute relative importance was calculated for each latent class's pooled and regional data sets. A total of 5015 completed surveys were analyzed. In general, the most important attribute for respondents was the availability of information and consent during health data sharing. In the latent class model, 4 classes of preference patterns were identified. While respondents in 2 classes strongly expressed their preferences for data sharing with opposing positions, respondents in the other 2 classes preferred not to share their data, but attribute levels of the situation could have had an impact on their preferences. Respondents generally found the following to be the most acceptable: a national authority or academic research project as the data user; being informed and asked to consent; and a review process for data transfer and use, or transfer only. On the other hand, collection of their data by a technological company and data use for commercial communication were the least acceptable. There was preference heterogeneity across Europe and within European regions. This study showed the importance of transparency in data use and oversight of health-related data sharing for European respondents. Regional and intraregional preference heterogeneity for "data collector," "data user," "reason," "type of consent," and "review" calls for governance solutions that would grant data subjects the ability to control their digital health data being shared within different contexts. These results suggest that the use of data without consent will demand weighty and exceptional reasons. An interactive and dynamic informed consent model combined with oversight mechanisms may be a solution for policy initiatives aiming to harmonize health data use across Europe.

Global Legal Contexts for the Protection of Human Rights: A Comparative Analysis

Objective: Human rights protection in today's globalized world necessitates familiarity with a wide range of legal systems. Human rights protection laws all throughout the world are compared and contrasted in this research. While human rights apply to every nation, they are complicated and are often codified in diverse ways. The research presented here emphasizes the need for a comprehensive understanding of these distinctions to ensure the survival of human rights and nature rights, human dignity, and justice. There are several obstacles to overcome when negotiating these legal terrains. Challenges arise from factors including divergent meanings, incomplete plans, cultural differences, and the ever-changing digital landscape.
 
 Method: The present research proposes a Synthesized Cultural Legal Frameworks (SCLF) for Universal Human Rights Protection as a means to provide universal human rights protection. This method is an attempt to recognize cultural differences while still achieving a worldwide approach to protecting human rights through a harmonized interpretation of the law.
 
 Result: This research has implications for policymakers, diplomats, lawyers, and activist organizations. This in-depth examination aids in gaining a better understanding of the intricate worldwide legal framework underlying environment and human rights.
 
 Conclusion: The research makes projections about the future of international collaboration, the success of legal harmonization initiatives, and global human rights results by modelling hypothetical situations based on possible legal harmonization efforts. Strategic planning and well-considered decision-making benefit from this dynamic method. The simulation analysis is based on the societal and economic effects and the efforts to harmonize the law.

What makes joint assessment procedures attractive to the innovative industry: successes, challenges, and proposed improvements.

Regulatory harmonization and convergence have been identified as the key driver in promoting efficient evaluation of medicines, reducing workload, and supporting earlier access to medicines on the African continent. There has been great progress to date in enhancing regulatory harmonization and convergence on the African continent via the Regional Economic Communities (RECs) and with the establishment of the Africa Medicines Agency (AMA). In this article, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Africa Regulatory Network (ARN) presents its perspective based on the available literature review and results from a survey conducted with innovative biopharmaceutical companies to gather experiences using regional joint assessment procedures (JAPs) in Africa, such as the East African Community Medicines Regulatory Harmonization (EAC-MRH), the West African Medicines Regulatory Harmonization (WA-MRH), and the Southern African Development Community Medicines Regulatory Harmonization (SADC-MRH) initiative through the ZAZIBONA Collaborative Procedure for Medicines Registration (ZaZiBoNa), and provides best practices in this evolving landscape. The article also assesses other collaborative registration pathways available to facilitating registration of pharmaceutical products in African countries, such as WHO Collaborative Registration Procedures (CRP), Swissmedic's Marketing Authorisation for Global Health Products (MAGHP) and EU Medicines for All (EU-M4ALL). Benefits and challenges of each of the existing pathways are discussed in this article. Main benefits include building more expert capacity and improved collaboration amongst experts, as well as shorter review timelines in some cases. Key challenges include the lack of predictability in the adherence to procedural timelines as defined per guidelines, lengthy timeline to achieve national marketing authorization following joint assessment, the lack of dedicated personnel, administrative issues during the submission process as well as additional country-specific requirements on top of JAP-specific requirements. Our recommendations for improvements include harmonization of requirements across countries and regions and with international standards, appropriate resource allocation for JAP activities to ensure adherence to timelines, use of JAPs throughout the entire product lifecycle and all product categories, adequate use of digital technologies, and improved communication and transparency with applicants. These improvements will allow industry to better plan their filing strategies for the region which will lead to overall improved usability of the JAPs in Africa and enable faster patient access.

Optimal Electricity Imbalance Pricing for the Emerging Penetration of Renewable and Low-Cost Generators

Problem definition: With the rise of renewables and the decline of fossil fuels, electricity markets are shifting toward a capacity mix in which low-cost generators (LCGs) are dominant. Within this transition, policymakers have been considering whether current market designs are still fundamentally fit for purpose. This research analyses a key aspect: the design of real-time imbalance pricing mechanisms. Currently, markets mostly use either single pricing or dual pricing as their imbalance pricing mechanisms. Single-pricing mechanisms apply identical prices for buying and selling, whereas dual-pricing mechanisms use different prices. The recent harmonization initiative in Europe sets single pricing as the default and dual pricing as the exception. This leaves open the question of when dual pricing is advantageous. We compare the economic efficiency of two dual-pricing mechanisms in current practice with that of a single-pricing design and identify conditions under which dual pricing can be beneficial. We also prove the existence of an optimal pricing mechanism. Methodology/results: We first analytically compare the economic efficiency of single-pricing and dual-pricing mechanisms. Furthermore, we formulate an optimal pricing mechanism that can deter the potential exercise of market power by LCGs. Our analytical results characterize the conditions under which a dual pricing is advantageous over a single pricing. We further compare the economic efficiency of these mechanisms with respect to our proposed optimal mechanism through simulations. We show that the proposed pricing mechanism would be the most efficient in comparison with others and discuss its practicability. Managerial implications: Our analytical comparison reveals market conditions under which each pricing mechanism is a better fit and whether there is a need for a redesign. In particular, our results suggest that existing pricing mechanisms are adequate at low/moderate market shares of LCGs but not for the high levels currently envisaged by policymakers in the transition to decarbonization, where the optimal pricing mechanism will become more attractive.Funding: R. Belo acknowledges funding by Fundação para a Ciência e a Tecnologia [UIDB/00124/2020, UIDP/00124/2020 and Social Sciences DataLab – PINFRA/22209/2016], POR Lisboa, and POR Norte [Social Sciences DataLab, PINFRA/22209/2016].Supplemental Material: The e-companion is available at https://doi.org/10.1287/msom.2021.0555 .

17th International Conference on Malignant Lymphoma, Palazzo dei Congressi, Lugano, Switzerland, 13 - 17 June, 2023.

Introduction: Staging of lung lesions in pediatric Hodgkin lymphoma (HL) is a long standing, controversial issue. Consortium groups define lung involvement and its distinction from E-lesions differently. Application of these criteria to individual patients are technically challenging and require expertise. The SEARCH group, working to create harmonization across consortia for the staging of pediatric HL, has completed this task for lung lesions. Methods: A survey of 7 case vignettes was distributed to 26 world experts in pediatric HL, replicating the previously published survey by Connors et al in 1984. Experts were asked to stage each case as lung involvement, or an E-lesion. Similar to Connors findings, our results demonstrated that experts were greatly divided on several cases, indicating ongoing differences in interpretation. Accordingly, the SEARCH group performed a harmonization initiative for the contemporary staging criteria for lung lesions. Representatives from each major consortium group (Pediatric Hodgkin Consortium, EuroNet PHL, Children’s Oncology Group) provided their current definitions for lung involvement, and rationale for staging decisions for the lung cases presented. Based on these discussions, a Delphi survey was drafted containing 12 statements pertaining to the staging criteria for lung lesions and distributed electronically to members of the SEARCH committee representing each consortium. Consensus was defined as a score of 3.75 or greater on a 5-point Likert scale (strongly disagree [1] to strongly agree [5]). Delphi rounds continued until consensus was achieved for all statements, or until a decision was made to remove a statement. Responses were collected anonymously and scores were pooled and reviewed after each round. Extreme scores and all comments were reviewed on committee calls before proceeding to the next round. Results: 21 experts responded to the first Delphi round, including pediatric oncologists, nuclear medicine radiologists, and radiation oncologists. 8 of 12 statements met consensus in Round 1. Several statements were edited to improve clarity and 1 statement was added. A second Delphi round was completed with 20 responses. All statements met consensus with the exception of one which was ultimately removed for group consensus that further investigation was required. Final consensus statements are available in Figure 1. Keywords: Hodgkin lymphoma, non-Hodgkin (pediatric, adolescent, and young adult) No conflicts of interests pertinent to the abstract.

Harmonization in Laboratory Medicine: The Big Picture

Harmonization of laboratory testing refers to ability to achieve the same result, within clinically acceptable limits and the same interpretation irrespective of the measurement procedure used, the unit or reference interval applied, and when and/or where a measurement made is in agreement. 1 The purpose of harmonizing laboratory data is to enhance patient care quality, leading to better patient outcomes and safety. Initiatives for harmonization and standardization have primarily concentrated on analytical processes carried out within the laboratories, particularly clinical chemistry testing. 2

Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry.

Background: Following the establishment of Economic Community of West African States Medicines Regulatory Harmonization (ECOWAS-MRH) initiative in 2017, it was considered timely to carry out an evaluation of the current status of the initiative's operating model by the pharmaceutical industry users. This study examined the challenges being encountered and identified strategies that would strengthen the ECOWAS-MRH initiative moving forward. Methods: The Process Effectiveness and Efficiency Rating (PEER) questionnaire was used to collect data from manufacturers who have submitted applications to the joint assessment procedure and had identified recommendations for improving the performance of the ECOWAS-MRH initiative. Results: Ten pharmaceutical manufacturer participants (innovator, generic foreign, generic local) all reported that harmonisation of registration requirements was a major benefit, allowing submission of the same dossier to multiple countries, reducing the application burden and saving time and resources. Additionally, receipt of the same list of questions from several countries enables the compilation of a single response package, resulting in shorter timelines for approvals compared to the individualised country responses. Another benefit of a harmonised registration process was the simultaneous accessibility of medicines in various markets. Key challenges included a lack of centralised submission and tracking, differences in regulatory performance of the national medical regulatory authorities, a lack of detailed information for applicants and a low motivation to use the ECOWAS-MRH route with a preference for other regulatory pathways in the ECOWAS member states. Conclusion: This study identified several approaches to increase the effectiveness of this initiative: the implementation of risk-based approaches such as use of reliance pathways; establishment of a robust information technology systems, building assessor capacity to facilitate processing and monitoring applications; and priority review of ECOWAS-MRH products.

Best practices in the African Medicines Regulatory Harmonization initiative: Perspectives of regulators and medicines manufacturers.

In the African Medicines Regulatory Harmonization initiative, national regulatory authorities (NRAs) within each of Africa's regional economic communities coordinate their activities, rely on the work of one another and other trusted regulatory authorities, and apply other principles of smart regulation. The first regional medicines regulatory harmonization (MRH) initiative in Africa was launched in 2012, with the goal of accelerating access to quality, safe, effective medical products, and now five MRH initiatives are active on the continent. Thus, a wealth of knowledge regarding best practices and approaches to dealing with common challenges has accumulated. The goal of this qualitative study was to gather and share information on these best practices. To do this, we conducted interviews with key participants from four regional MRH initiatives-the East African Community (EAC), Southern African Development Community (SADC), Economic Community of West African States (ECOWAS), and Intergovernmental Authority on Development (IGAD)-as well as representatives from the pharmaceutical industry. Here we explore major themes that emerged from the interviews: 1. Transparency and reliability are critical; 2. Reliance is essential for smart regulation; 3. Multiple successful strategies for NRA capacity building have been identified; 4. Communication between heads of agencies is essential; 5. Cooperation at the regional level is not possible without leadership at the NRA level; 6. Sustainable funding remains challenging; and 7. Industry has important insights. We hope that the information on best practices shared in this article can benefit regional MRH initiatives inside and outside of Africa, ultimately helping them accelerate access to quality, safe, effective medical products.

The domestication of the African Union model law on medical products regulation: Perceived benefits, enabling factors, and challenges.

In 2016, the African Union (AU) Model Law on Medical Products Regulation was endorsed by AU Heads of State and Government. The aims of the legislation include harmonisation of regulatory systems, increasing collaboration across countries, and providing a conducive regulatory environment for medical product/health technology development and scale-up. A target was set to have at least 25 African countries domesticating the model law by 2020. However, this target has not yet been met. This research aimed to apply the Consolidated Framework for Implementation Research (CFIR) in analysing the rationale, perceived benefits, enabling factors, and challenges of AU Model Law domestication and implementation by AU Member States. This study was a qualitative, cross-sectional, census survey of the national medicines regulatory authorities (NRAs) of Anglophone and Francophone AU Member States. The heads of NRAs and a senior competent person were contacted to complete self-administered questionnaires. The perceived benefits of model law implementation include enabling the establishment of an NRA, improving NRA governance and decision-making autonomy, strengthening the institutional framework, having streamlined activities which attract support from donors, as well as enabling harmonisation, reliance, and mutual recognition mechanisms. The factors enabling domestication and implementation are the presence of political will, leadership, and advocates, facilitators, or champions for the cause. Additionally, participation in regulatory harmonisation initiatives and the desire to have legal provisions at the national level that allow for regional harmonisation and international collaboration are enabling factors. The challenges encountered in the process of domesticating and implementing the model law are the lack of human and financial resources, competing priorities at the national level, overlapping roles of government institutions, and the process of amending/repealing laws being slow and lengthy. This study has enabled an improved understanding of the AU Model Law process, the perceived benefits of its domestication, and the enabling factors for its adoption from the perspective of African NRAs. NRAs have also highlighted the challenges encountered in the process. Addressing these challenges will result in a harmonised legal environment for medicines regulation in Africa and be an important enabler for the effective operation of the African Medicines Agency.

Autoantibodies to dsDNA in the diagnosis, classification and follow-up of patients with systemic lupus erythematosus

Autoantibodies, in particular anti-dsDNA antibodies, are increasingly used for diagnosis, classification and follow-up of patients with SLE. Since standardization of autoantibody assays is a major challenge, more attention should be paid to harmonization initiatives and better definition of required test characteristics in classification criteria. For diagnosis and follow-up separate multi-center studies are required to establish test characteristics of distinct immuno-assays for both purposes. Finally, such studies should consider not to evaluate SLE as a single disease, but as a disease with distinct subtypes.

News and perspectives for Annals of Applied Biology in 2023: Looking forward to more and more submissions

News and perspectives for <scp><i>Annals of Applied Biology</i></scp> in 2023: Looking forward to more and more submissions