This article explores how the African Vaccine Manufacturing Accelerator can support the sustainable production of vaccines in Africa. It highlights the value of the accelerator in relation to the Regional Vaccine Manufacturing Collaborative. The author proposes that this novel financing instrument should be well-designed and implemented in line with the targets of the Partnerships for African Vaccine Manufacturing. It should not be a decoupling tool to appease the institutional environment of the global vaccine market, but a sustainable demonstration of the goodwill and commitment of political and technical leaders to ensure equitable access to routine and epidemic-related vaccines in Africa.

Having a robust, integrated regulatory system is important for ensuring the availability of safe and efficacious medical products of good quality and for protecting public health. However, less than 30% of countries globally have reached the required regulatory maturity level three, with low- and middle-income countries facing challenges in attracting and retaining qualified staff. World Health Organization (WHO) advocates for systematic workforce development, including competency-based education, to address these gaps. We provide perspectives on a systematic approach to capacity building of medicine regulators based on the experience and lessons learnt in developing and piloting the WHO global competency framework for medicine regulators through three scenarios. A systematic approach to capacity building, such as the human performance technology model, can be used to implement the WHO competency framework as part of organizational performance improvement while ensuring that initiatives are well-defined, targeted, and aligned with organizational goals. The competency framework can be used in different contexts, such as improving organization performance for individual regulatory authorities, strengthening regional collaborations, harmonization and reliance on medical products assessment and joint good manufacturing practices inspections of pharmaceutical manufacturers, and developing learning programs for medicine regulators. A competency-based learning approach for regulatory professionals ensures the transfer of learning to the workplace by integrating real-world practices in learning activities and assessments. Further work is required to develop and validate the assessment instruments, apply the competency framework in other contexts, expanding the learning programmes while continuously providing feedback for further refinement of the competency framework and implementation support tools.

The sustained growth of global meat consumption incentivized the development of the meat substitute industry. However, long-term global commercialization of meat substitutes faces challenges that arise from technological innovation, limited consumer awareness, and an imperfect regulatory environment. Many important questions require urgent answers. This paper presents a review of issues affecting meat substitute manufacturing and marketing, and helps to bridge important gaps which appear in the literature. To date, global research on meat substitutes focuses mainly on technology enhancement, cost reduction, and commercialization with a few studies focused on a regulatory perspective. Furthermore, the studies on meat substitute effects on environmental pollution reduction, safety, and ethical risk perception are particularly important. A review of these trends leads to conclusions which anticipate the development of a much broader market for the meat substitute industry over the long term, the gradual discovery of solutions to technical obstacles, upgraded manufacturing, the persistent perception of ethical risk and its influence on consumer willingness to accept meat substitutes, and the urgent need for constructing an effective meat substitute regulatory system.

The major goal of animal breeding is the genetic enhancement of economic traits. The CRISPR/Cas system, which includes nuclease-mediated and base editor mediated genome editing tools, provides an unprecedented approach to modify the mammalian genome. Thus, farm animal genetic engineering and genetic manipulation have been fundamentally revolutionized. Agricultural animals with traits of interest can be obtained in just one generation (and without long time selection). Here, we reviewed the advancements of the CRISPR (Clustered regularly interspaced short palindromic repeats)/Cas (CRISPR associated proteins) genome editing tools and their applications in animal breeding, especially in improving disease resistance, production performance, and animal welfare. Additionally, we covered the regulations on genome-edited animals (GEAs) and ways to accelerate their use. Recommendations for how to produce GEAs were also discussed. Despite the current challenges, we believe that genome editing breeding and GEAs will be available in the near future.

Smartphone technology can support paperless reporting of adverse drug reactions (ADRs). The aims of this study were to systematically assess smartphone ADR-reporting applications, understand their qualitative and quantitative impact on ADR reporting, and garner key lessons from owners and developers.
This study had three components: (1) An assessment of ADR-reporting apps, (2) an online survey on the impact of app implementation on ADR reporting and the experiences of app developers and owners, and (3) a search of VigiBase, the World Health Organization global database of individual case safety reports (ICSRs), to observe trends in the number of ADR reports targeting countries where the apps were implemented.
Twenty-two apps were included. Eight out of the 22 apps were for countries in the WHO African region. Features observed included E2B data elements (E stands for efficacy) and functions supporting reporting and user engagement. Seventeen app developers and owners answered to the survey and reported overall positive experiences with app features, and post-launch increases in the total number of ICSRs. User type and user environment were cited as factors influencing app use: Respondents said younger people and/or those with an inclination to use technology were more likely to use apps compared to older or more technology-averse people, while respondents in countries with limited internet connectivity reported persistent difficulties in app use.
Smartphone apps for reporting ADRs offer added value compared to conventional reporting tools. Reporting tools should be selected based on interface features and factors that may influence app usage.

Aim: This study compared regulatory systems of competent authorities related to GMP for marketing authorization of advanced therapy medicinal products (ATMPs). Methods: Dossiers for GMP and regulations and guidelines for facilities and equipment were analyzed using gap analysis. The risk-based approach (RBA) and GMP inspection were evaluated with regulations and guidelines. Results: The dossier was similar for the competent authorities. However, whereas a site master file is required in the EU, Japan and South Korea, the US requires only a biologics license application. The regulations and guidelines of facilities and equipment emphasized preventing contamination. There are differences among the competent authorities in GMP inspection and RBAs. Conclusion: Differences among the competent authorities in the marketing authorization process related to GMP for ATMPs should be considered.

The recent article \"Exploring the COVID-19 vaccine candidates against SARS-CoV-2 and its variants: where do we stand and where do we go?\" published on December 2 is thought provoking. The authors highlight critical disparities in the manufacture and distribution of COVID-19 vaccines although over 350 COVID-19 vaccine candidates are reported to be in the preclinical and clinical development phase. The history of vaccine research and production in India is as ancient as the history of vaccines themselves. Interestingly, vaccine manufacture that was once monopolized by India, declined in its productivity and stature, primarily for the lack of a strategic vision. The recent approval of COVAXIN, designed and developed in India, for emergency use by the World Health Organization is significant for a huge and diverse developing country such as India, especially to transform a weak regulatory system, and enhance public trust.

BACKGROUND: Multidrug-resistant Acinetobacter baumannii is galloping, posing threat to tackle, and leaving us with limited options of treatment.
METHODS: The purpose of this study is to find the genotypic association in drug-resistant A. baumannii isolated from different sterile body fluids. Matrix-assisted laser desorption/ionization-time of flight confirmed A. baumannii isolates were taken and minimum inhibitory concentration (MIC) was determined by VITEK-2 AST system. The presence of resistance nodulation-division (RND)-efflux pump genes AdeABC-RS was detected by multiplex polymerase chain reaction.
RESULTS: Of the total 40 A. baumannii, 32 (80%) were multidrug resistant though all isolates were susceptible to Tigecycline. Similarly, 26 (81.25%) isolates were positive for RND-efflux pump genes AdeABC-RS.
CONCLUSIONS: RND efflux pump AdeABC-RS system plays a significant role in emerging multi drug resistant A. baumannii. Mutation in AdeS gene deciphers the role of regulatory gene. Hence, antimicrobial stewardship should be strictly followed and efflux pump inhibiting substances should be vigorously searched to bring back the era of existing antibiotics.

China has made efforts toward the preservation and utilization of human genetic resources (HGRs). In recent years, in the face of various issues that have become increasingly prominent in HGR research, China has continuously strengthened legislation and ethics, and has initially established a relatively complete legal system and ethical guidelines. In the design of regulatory responsibilities, a multisectoral linkage of the Ministry of Science and Technology (MOST), the National Health Commission (NHC), the National Medical Products Administration (NMPA), and the National Intellectual Property Administration (CNIPA) has been formed. In the supervision system, it includes a three-tier structure of Laws/Acts-Regulations-Guidance. In terms of management content, it mainly draws on the basic principles of international conventions such as the Convention on Biological Diversity (CBD), and implements examination and approval filing management and ethical supervision of HGR research in China.

Clostridium perfringens toxin production is often regulated by the Agr-like quorum sensing (QS) system signaling the VirS/VirR two-component regulatory system (TCRS), which consists of the VirS membrane sensor histidine kinase and the VirR response regulator. VirS/VirR is known to directly control expression of some genes by binding to a DNA binding motif consisting of two VirR boxes located within 500 bp of the target gene start codon. Alternatively, the VirS/VirR system can indirectly regulate production levels of other proteins by increasing expression of a small regulatory RNA, VR-RNA. Previous studies demonstrated that C. perfringens beta-toxin (CPB) production by C. perfringens type B and C strains is positively regulated by both the Agr-like QS and the VirS/VirR TCRS, but the mechanism has been unclear. The current study first inactivated the vrr gene encoding VR-RNA to show that VirS/VirR regulation of cpb expression does not involve VR-RNA. Subsequently, bioinformatic analyses identified a potential VirR binding motif, along with a predicted strong promoter, ∼1.4 kb upstream of the cpb open reading frame (ORF). Two insertion sequences were present between this VirR binding motif/promoter region and the cpb ORF. PCR screening of a collection of strains carrying cpb showed that the presence and sequence of this VirR binding motif/promoter is highly conserved among CPB-producing strains. Reverse transcription-PCR (RT-PCR) and a GusA reporter assay showed this VirR binding motif is important for regulating CPB production. These findings indicate that VirS/VirR directly regulates cpb expression via VirS binding to a VirR binding motif located unusually distant from the cpb start codon. IMPORTANCE Clostridium perfringens beta-toxin (CPB) is only produced by type B and C strains. Production of CPB is essential for the pathogenesis of type C-associated infections, which include hemorrhagic necrotizing enteritis and enterotoxemia in both humans and animals. In addition, CPB can synergize with other toxins during C. perfringens gastrointestinal diseases. CPB toxin production is cooperatively regulated by the Agr-like quorum sensing (QS) system and the VirS/VirR two-component regulatory system. This study now reports that the VirS/VirR regulatory cascade directly controls expression of the cpb gene via a process involving a VirR box binding motif located unusually far (∼1.4 kb) upstream of the cpb ORF. This study provides a better understanding of the regulatory mechanisms for CPB production by the VirS/VirR regulatory cascade.