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MEDICC Review 2021At the time of this writing, more than 10 million Cubans (nearly 90% of the country's population), had received at least their first dose of Soberana 02 or Abdala, two...
At the time of this writing, more than 10 million Cubans (nearly 90% of the country's population), had received at least their first dose of Soberana 02 or Abdala, two of five vaccine candidates for SARS-CoV-2 developed and produced on the island. Late-phase clinical trial data revealed that Abdala is 92.28% effective after the full, three-dose cycle and Soberana 02 is 91.2% effective after two doses, when followed by a booster of Soberana Plus.[1] Cuban health authorities have committed to vaccinating the entire population, including children aged 3-18 years old, using these vaccines by the end of 2021. The first pre-clinical, peer-reviewed data are available,[2] with clinical trial results already submitted to various international journals. Building on decades of biotechnology know-how developing, producing and administering 11 preventive vaccines for childhood diseases-used in the nation's universal health system and also marketed elsewhere-Cuba is the first, and to date only, country in Latin America and the Caribbean to develop its own vaccine candidates for COVID-19 (Soberana 01; Soberana 02; Soberana Plus; Abdala and Mambisa; see Box on following page). In a strategy designed to ensure comprehensive and importantly, independent solutions to the global health crisis, research institutes and manufacturing facilities coordinated by BioCubaFarma-the country's biopharmaceutical conglomerate-have also developed COVID-19 treatments and essential medical equipment. To gain a better understanding of the regulatory process involved, MEDICC Review turned to Olga Lidia Jacobo-Casanueva, Director of the Center for State Control of Medicines and Medical Devices (CECMED), Cuba's national regulatory authority (NRA). A clinical microbiologist, Jacobo-Casanueva served as interim director throughout 2020 before becoming director in January 2021. She has spent nearly her entire career at CECMED, working her way up the ranks in a unique trajectory: from her first position in 1992 in the Center's microbiology laboratories, she has since worked in all but one of the six areas required by WHO to qualify as a National Regulatory Authority of Reference (NRAr; CECMED was certified as a Level 4 NRAr in 2011, a qualification it maintains). In short, Jacobo-Casanueva is a regulatory polymath, with hands-on experience in nearly every facet of regulation. She is also an adjunct researcher in the Faculty of Biology at the University of Havana. Cuba's decision to confront the pandemic autonomously by developing preventive vaccines to control COVID-19 is deliberate and fraught with challenges. With dozens of ongoing clinical trials, coupled with the declining epidemiological and economic situation in Cuba-exacerbated by tightened US sanctions affecting all facets of COVID-19 prevention and response-we appreciate the time Jacobo-Casanueva took from her schedule to parse the complex regulatory mechanisms required to introduce Cuban and imported products into the national health system. Editor's note: Just days after this interview was conducted in Havana, CECMED granted Emergency Use Authorization for Abdala, one of five Cuban COVID-19 vaccine candidates undergoing clinical trials since 2020.
Topics: Adolescent; COVID-19; COVID-19 Vaccines; Child; Child, Preschool; Cuba; Female; Humans; Pandemics; SARS-CoV-2
PubMed: 34516531
DOI: 10.37757/MR2021.V23.N3.3 -
Clinical Therapeutics Aug 2022For more than a decade, the World Health Organization, Pan American Health Organization, Pan-American Network or Drug Regulatory Harmonization, and the International... (Review)
Review
For more than a decade, the World Health Organization, Pan American Health Organization, Pan-American Network or Drug Regulatory Harmonization, and the International Conference of Drug Regulatory Authorities, have encouraged regulators to adopt reliance and recognition pathways to reduce duplication, improve efficiency and efficacy, and strengthen regulatory capabilities, in order to facilitate marketing authorization approval, thereby maintaining supply chain integrity. Several factors have limited the more widespread implementation of reliance pathways in Latin America, among which is having the appropriate legal tools in place between and among agencies. Key among these tools are the Memorandum of Understanding (MOU) and cooperation agreements. Herein we have reviewed the content and the characteristics of MOUs and cooperation agreements available on the official websites of the regulatory agencies of the region (we found 11 multilateral MOUs and 8 cooperation agreements published), signed by Latin American agencies and interregional organizations. In this commentary, common characteristics are identified and recommendations for further implementation are made to promote communication, information sharing, and trust, thereby supporting the broader use of reliance pathways in the region.
Topics: Humans; Latin America; Organizations; Pan American Health Organization
PubMed: 35798570
DOI: 10.1016/j.clinthera.2022.06.005 -
Chinese Medicine 2018Internationalization of Traditional/Complementary Medicine (T&CM) products is important for initiating and sustaining developments in this field. Particularly for... (Review)
Review
Internationalization of Traditional/Complementary Medicine (T&CM) products is important for initiating and sustaining developments in this field. Particularly for traditional Chinese medicines (TCMs), the global market continues to expand due to an interest in the potential clinical benefits of traditional approaches that are largely considered lower risk and lower cost than many conventional treatments. While the benefits of internationalization hold clear advantages for the business of T&CM products, keeping abreast of regulatory processes in different countries and regions that regularly revise market entry requirements is challenging. At present, the regulations of T&CM products are country specific and largely based on a risk-based assessment with a focus on protecting the consumer. To date, systematic analysis of these regulatory differences between countries and regions is limited. Publically available information about the legal requirements for the market entry of T&CM products were obtained from the relevant regulatory authority's websites for selected countries and regions (Macau-China, Hong Kong-China, Singapore, Australia, Canada, the European countries and the US). The market entry requirements in terms of quality, safety and efficacy of T&CM products for each country were analyzed and compared. Major differences were identified in the classification of T&CM products, market entry pathways, requirements of compliance with Good Manufacturing Practices; and level of evidence to demonstrate safety and efficacy based on historical use, non-clinical and clinical studies. Variations in the evaluation standards adopted by regulatory authorities pose a number of barriers and opportunities for the internationalization of T&CM products and have great implications for internationalization of TCMs from the sponsors' and the regulators' perspectives.
PubMed: 30337951
DOI: 10.1186/s13020-018-0209-6 -
Journal of Pharmaceutical Sciences May 2022Recent advancements in data engineering, data science, and secure cloud storage can transform the current state of global Chemistry, Manufacturing, and Controls (CMC)... (Review)
Review
Recent advancements in data engineering, data science, and secure cloud storage can transform the current state of global Chemistry, Manufacturing, and Controls (CMC) regulatory activities to automated online digital processes. Modernizing regulatory activities will facilitate simultaneous global submissions and concurrent collaborative reviews, significantly reducing global licensing timelines and variability in globally registered product details. This article describes advancements made within the pharmaceutical industry from theoretical concepts to utilization of structured content and data in CMC submissions. The term Structured Content and Data Management (SCDM) outlines the end-to-end scientific data lifecycle from capture in source systems, aggregation into a consolidated repository, and transformation into semantically structured blocks with metadata defining relationships between scientific data and business contexts. Automation of regulatory authoring (termed Structured Content Authoring) is feasible because SCDM makes data both human and machine readable. It will offer health authorities access to the digital data beyond the current standard of PDF documents and, for a review process, SCDM would "enrich the effectiveness, efficiency, and consistency of regulatory quality oversight" (Yu et al., 2019). SCDM is a novel solution for content and data management in regulatory submissions and can enable faster access to critical therapies worldwide.
Topics: Commerce; Data Management; Drug Industry; Humans
PubMed: 34610323
DOI: 10.1016/j.xphs.2021.09.046 -
Frontiers in Sociology 2022This article discusses similarities between the finance industry and the gambling industry. It considers empirical studies from both fields and compares both industries...
This article discusses similarities between the finance industry and the gambling industry. It considers empirical studies from both fields and compares both industries with regard to possible substitution effects. Afterwards, the current regulatory approach to gambling and financial markets is discussed. Based on this literature review, the author points out that regulators need to acknowledge the fact that both markets possess addictive properties and attract certain risk-seeking individuals. Moreover, the regulators need to find a way to align their fundamentally different objectives to find common solutions to cross-industry problems. Finally, an increased cooperation between (state) authorities is necessary. This cooperation could help to protect traders from developing gambling-related problems, provide significant insights for industry-wide and product-specific regulation and lead to a more informed use of technology for harm prevention purposes. The most important similarities and differences of both markets and the resulting regulatory implications are briefly summarized.
PubMed: 36479159
DOI: 10.3389/fsoc.2022.1023307 -
The AAPS Journal Sep 2022This publication provides some industry reflections on experiences from the Chemistry, Manufacturing, and Controls (CMC) development and manufacture and supply of... (Review)
Review
This publication provides some industry reflections on experiences from the Chemistry, Manufacturing, and Controls (CMC) development and manufacture and supply of vaccines and therapies in response to the COVID-19 pandemic. It integrates these experiences with the outcomes from the collaborative work between industry and regulators in recent years on innovative science- and risk-based CMC strategies to the development of new, high-quality products for unmet medical needs. The challenges for rapid development are discussed and various approaches to facilitate accelerated development and global supply are collated for consideration. Relevant regulatory aspects are reviewed, including the role of Emergency Use/Conditional Marketing Authorizations, the dialogue between sponsors and agencies to facilitate early decision-making and alignment, and the value of improving reliance/collaborative assessment and increased collaboration between regulatory authorities to reduce differences in global regulatory requirements. Five areas are highlighted for particular consideration in the implementation of strategies for the quality-related aspects of accelerated development and supply: (1) the substantial need to advance reliance or collaborative assessment; (2) the need for early decision making and streamlined engagement between industry and regulatory authorities on CMC matters; (3) the need to further facilitate 'post-approval' changes; (4) fully exploiting prior and platform knowledge; and (5) review and potential revision of legal frameworks. The recommendations in this publication are intended to contribute to the discussion on approaches that can result in earlier and greater access to high-quality pandemic vaccines and therapies for patients worldwide but could also be useful in general for innovative medicines addressing unmet medical needs.
Topics: COVID-19; Humans; Pandemics; Vaccines
PubMed: 36168002
DOI: 10.1208/s12248-022-00751-9 -
Annals of the New York Academy of... May 2021The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member...
The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices. Despite this effort, a recent WHO survey (conducted in 2019-2020) has revealed four main remaining challenges: unavailable/insufficient reference products in the country; lack of resources; problems with the quality of some biosimilars (and even more with noninnovator products); and difficulties with the practice of interchangeability and naming of biosimilars. The following have been identified as opportunities/solutions for regulatory authorities to deal with the existing challenges: (1) exchange of information on products with other regulatory authorities and accepting foreign licensed and sourced reference products, hence avoiding conducting unnecessary (duplicate) bridging studies; (2) use of a "reliance" concept and/or joint review for the assessment and approval of biosimilars; (3) review and reassessment of the products already approved before the establishment of a regulatory framework for biosimilar approval; and (4) setting appropriate regulatory oversight for good pharmacovigilance, which is essential for the identification of problems with products and establishing the safety and efficacy of interchangeability of biosimilars.
Topics: Biosimilar Pharmaceuticals; Drug Approval; Guidelines as Topic; Health Information Exchange; Humans; Pharmacovigilance; Surveys and Questionnaires; World Health Organization
PubMed: 33222245
DOI: 10.1111/nyas.14522 -
Transgenic Research Apr 2023Gene drive-modified mosquitoes (GDMMs) are being developed as possible new tools to prevent transmission of malaria and other mosquito-borne diseases. To date no GDMMs... (Review)
Review
Gene drive-modified mosquitoes (GDMMs) are being developed as possible new tools to prevent transmission of malaria and other mosquito-borne diseases. To date no GDMMs have yet undergone field testing. This early stage is an opportune time for developers, supporters, and possible users to begin to consider the potential regulatory requirements for eventual implementation of these technologies in national or regional public health programs, especially as some of the practical implications of these requirements may take considerable planning, time and coordination to address. Several currently unresolved regulatory questions pertinent to the implementation of GDMMs are examined, including: how the product will be defined; what the registration/approval process will be for placing new GDMM products on the market; how the potential for transboundary movement of GDMMs can be addressed; and what role might be played by existing multinational bodies and agreements in authorization decisions. Regulation and policies applied for registration of other genetically modified organisms or other living mosquito products are assessed for relevance to the use case of GDMMs to prevent malaria in Africa. Multiple national authorities are likely to be involved in decision-making, according to existing laws in place within each country for certain product classes. Requirements under the Cartagena Protocol on Biodiversity will be considered relevant in most countries, as may existing regulatory frameworks for conventional pesticide, medical, and biocontrol products. Experience suggests that standard regulatory processes, evidence requirements, and liability laws differ from country to country. Regional mechanisms will be useful to address some of the important challenges.
Topics: Animals; Culicidae; Gene Drive Technology; Malaria; Policy
PubMed: 36920721
DOI: 10.1007/s11248-023-00335-z -
Journal of Generic Medicines Dec 2022With the emergence of new and re-emerging viral diseases, scientists have been working to produce new medications with novel targets and pathways. The discovery of safe... (Review)
Review
With the emergence of new and re-emerging viral diseases, scientists have been working to produce new medications with novel targets and pathways. The discovery of safe and efficacious antiviral medicines is critical due to the constant introduction of new virus types and short lifetime of protection. Since the outbreak, there have been significant efforts to repurpose existing and licensed medications for rapid human testing and possible emergency use authorizations. The exploration of surviving medications for new restorative motives is known as drug repurposing. It is a successful, rapid, and highly reliable alternative to traditional drug methods. COVID-19 is being treated using a number of repurposed and new medicines. Molnupiravir is a repurposed Covid-19 medicine that was specifically developed to cure influenza and is used to treat mild to moderately ill Covid-19 patients with high risk of becoming seriously ill. The importance of medication repurposing, as well as the regulatory procedure for repurposed pharmaceuticals and Emergency Use Authorization in the United States, are summarized in this article.
PubMed: 38603247
DOI: 10.1177/17411343221115819 -
GM Crops & Food Dec 2023Gene technologies, such as transgenesis and new breeding techniques (NBTs), expand the toolbox for plant breeding. Many countries in Africa, however, have long been seen...
Gene technologies, such as transgenesis and new breeding techniques (NBTs), expand the toolbox for plant breeding. Many countries in Africa, however, have long been seen as "slow adopters" of gene technologies for several reasons, one being the lack of, or overly restrictive, biosafety regulatory frameworks. This is sometimes attributed to the influence of the precautionary-oriented EU biosafety policies. This study analyses and compares the biosafety regulatory frameworks and their implementation in Kenya, Nigeria and Uganda, and in the EU member state Sweden. The focus is on (1) the structure of the biosafety regulatory frameworks including the scope of the legislation, (2) the duration and cost of regulatory authorization for field trials with genetically modified (GM) plants, and (3) the regulatory approach to NBT products, i.e. to what extent NBT products are subject to the provisions of the biosafety regulatory framework. The data was collected through studying relevant legal and policy documents as well as interviewing regulatory officers and researchers in the respective countries. We found that the regulatory procedures in the selected countries are relatively straightforward, while the costs and duration may present a challenge. The regulatory approach to NBT products differ between the selected African countries and Sweden, the latter which follows EU regulations. The results are discussed in terms of the impact the regulatory developments in these four jurisdictions may have on international R&D collaborations involving the use of gene technologies and we also weigh the results against the common conception that Europe exerts a heavy influence on African countries in this technology field.
Topics: Biotechnology; Nigeria; Kenya; Uganda; Sweden; Containment of Biohazards; Plant Breeding
PubMed: 36987578
DOI: 10.1080/21645698.2023.2194221