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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 -
EFSA Journal. European Food Safety... Aug 2023The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the... (Review)
Review
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Austria and co-rapporteur Member State Italy for the pesticide active substance folpet and of confirmatory data following the MRL review under Article 12 of Regulation (EC) No 396/2005. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of folpet as a fungicide on barley, wheat and wine grape (field uses) and tomato (field and greenhouse uses). The reliable end points, appropriate for use in regulatory risk assessment and the confirmatory data, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.
PubMed: 37599799
DOI: 10.2903/j.efsa.2023.8139 -
Therapeutic Advances in Drug Safety 2020A favorable benefit-risk profile remains an essential requirement for marketing authorization of medicinal drugs and devices. Furthermore, prior subjective, implicit and... (Review)
Review
UNLABELLED
A favorable benefit-risk profile remains an essential requirement for marketing authorization of medicinal drugs and devices. Furthermore, prior subjective, implicit and inconsistent ad hoc benefit-risk assessment methods have rightly evolved towards more systematic, explicit or "structured" approaches. Contemporary structured benefit-risk evaluation aims at providing an objective assessment of the benefit-risk profile of medicinal products and a higher transparency for decision making purposes. The use of a descriptive framework should be the preferred starting point for a structured benefit-risk assessment. In support of more precise assessments, quantitative and semi-quantitative methodologies have been developed and utilized to complement descriptive or qualitative frameworks in order to facilitate the structured evaluation of the benefit-risk profile of medicinal products. In addition, quantitative structured benefit-risk analysis allows integration of patient preference data. Collecting patient perspectives throughout the medical product development process has become increasingly important and key to the regulatory decision-making process. Both industry and regulatory authorities increasingly rely on descriptive structured benefit-risk evaluation and frameworks in drug, vaccine and device evaluation and comparison. Although varied qualitative methods are more commonplace, quantitative approaches have recently been emphasized. However, it is unclear how frequently these quantitative frameworks have been used by pharmaceutical companies to support submission dossiers for drug approvals or to respond to the health authorities' requests. The objective of this study has been to identify and review, for the first time, currently available, published, structured, quantitative benefit-risk evaluations which may have informed health care professionals and/or payor as well as contributed to decision making purposes in the regulatory setting for drug, vaccine and/or device approval.
PLAIN LANGUAGE SUMMARY
The review of the benefits and the risks associated with a medicinal product is called benefit-risk assessment. One of the conditions for a medicinal product to receive marketing authorization is to demonstrate a positive benefit-risk balance in which the benefits outweigh the risks. In order to enhance the transparency and consistency in the assessment of benefit-risk balance, frameworks and quantitative methods have been developed for decision making purposes and regulatory approvals of medicinal products. This article considers published quantitative benefit-risk evaluations which may have informed health care professionals and/or payor as well as contributed to decision making purposes in the regulatory setting for drug, vaccine and/or device approval.
PubMed: 33343857
DOI: 10.1177/2042098620976951 -
Journal of Applied Microbiology Dec 2017Regulatory guidelines are in place across the world to ensure that approval of antibiotics is consistent with current scientific understanding of quality, efficacy and... (Review)
Review
Regulatory guidelines are in place across the world to ensure that approval of antibiotics is consistent with current scientific understanding of quality, efficacy and safety including minimizing the risk of the development of antibiotic resistance. We suggest the regulatory process is fit for purpose and does indeed approve products that are safe for use with regard to development of antibiotic resistance. However, we maintain that in order to preserve the longevity of antibiotics, treatment should be based on an established diagnosis and normally only antibiotics authorized for the diagnosed indication and indicated bacteria are used. Furthermore, susceptibility testing should be carried out whenever possible. Despite a general acceptance that antibiotic resistance is a significant issue, antibiotics can still receive a marketing authorization without a sponsor having to generate a clinical breakpoint. The consequence of this is that for many antibiotics we have no measure of what is resistant and what is susceptible at the approved dose. We argue that the time is right for all approvals of new or existing antibiotics to have independently agreed clinical breakpoints, as part of the regulatory process, without which talk of resistance is somewhat meaningless. This is relevant not only for novel antibiotics but also for generic compounds.
Topics: Animals; Anti-Bacterial Agents; Bacteria; Drug Resistance, Bacterial; Humans; Legislation, Veterinary; Politics; Veterinary Medicine
PubMed: 28779537
DOI: 10.1111/jam.13553 -
Occupational and Environmental Medicine Dec 2022This study aimed to determine the effects of the Labour Inspectorate Authority's (LIA's) regulatory tools on psychosocial and biomechanical work factors in the Norwegian... (Randomized Controlled Trial)
Randomized Controlled Trial
Effects of the Labour Inspectorate Authority's regulatory tools on psychosocial and biomechanical work factors in Norwegian home care services: a cluster randomised controlled trial.
OBJECTIVES
This study aimed to determine the effects of the Labour Inspectorate Authority's (LIA's) regulatory tools on psychosocial and biomechanical work factors in the Norwegian municipal home care services.
METHODS
A cluster-randomised controlled trial conducted in the home care services with employee questionnaire data on work factors at baseline, and 6 and 12 months after the interventions. In total, 96 eligible municipalities were randomly assigned to either the control group or one of two interventions: (1) labour inspection visits, based on the LIA's standard inspections; and (2) guidance-through-workshops, where the participating services highlighted issues and trained labour inspectors provided guidance based on existing labour laws and regulations.
RESULTS
No favourable intervention effect was observed for the inspection intervention. No effects were observed for most of the variables in the guidance intervention, although an effect was observed for the following psychosocial factors: decision control, control over work intensity and empowering leadership. However, after adjusting for multiple testing, none of the observed effects were statistically significant.
CONCLUSION
Labour inspections did not affect psychosocial and biomechanical work factors in the home care services. A favourable effect of the guidance intervention on psychosocial work factors was observed. However, this was not evident after adjusting for multiple testing. Further research is needed to elaborate on how labour inspections and other regulatory tools can impact psychosocial and biomechanical work factors.
TRIAL REGISTRATION NUMBER
NCT03855163.
Topics: Humans; Home Care Services; Surveys and Questionnaires; Norway
PubMed: 36167785
DOI: 10.1136/oemed-2022-108470 -
JAMA Health Forum Jun 2023The US Food and Drug Administration (FDA) has expansive regulatory flexibility regarding the quality and quantity of evidence it deems sufficient to approve new drugs,...
IMPORTANCE
The US Food and Drug Administration (FDA) has expansive regulatory flexibility regarding the quality and quantity of evidence it deems sufficient to approve new drugs, which has been increasingly used to grant approval based on less certain evidence of benefit. However, the FDA's regulatory flexibility with respect to standards for approval has not been matched by sufficient stringency in its exercise of postmarket safeguards, including the FDA's authority and willingness to require confirmation of benefit through postmarket efficacy studies or to withdraw approval when benefit is not confirmed.
OBJECTIVE
To identify and evaluate opportunities for the FDA to extend its authority to require postmarket efficacy studies and use expedited withdrawal procedures for drugs approved despite substantial residual uncertainty outside the accelerated approval pathway.
EVIDENCE
The FDA's current approaches to regulatory flexibility with respect to standards for drug approval; examples of shortcomings in the postmarket period; existing statutes and regulations governing the scope of the FDA's authority to impose and enforce postmarket study requirements; and recent legislative reform and agency action regarding the accelerated approval pathway.
FINDINGS
Drawing on the broad language of the federal Food, Drug, and Cosmetic Act, the FDA could independently extend its core accelerated approval authorities-required postmarket efficacy studies and expedited withdrawal procedures-to any drug approved with substantial residual uncertainty regarding benefit, such as those supported by a single pivotal trial. To avoid exacerbating existing problems that have become evident during the past 3 decades of experience using the accelerated approval pathway, however, the FDA must ensure that postmarket studies are well designed and completed quickly, while compelling expedited withdrawal when needed.
CONCLUSIONS AND RELEVANCE
Under current FDA approaches to drug approval, patients, clinicians, and payers may be left with little confidence about a drug's benefit not only when it first enters the market but also for an extended period thereafter. If policy makers continue to favor earlier market access over evidentiary certainty, flexible approvals must be matched by more expansive use of postmarket safeguards, an approach possible within the FDA's existing legal authorities.
Topics: United States; Humans; Pharmaceutical Preparations; United States Food and Drug Administration; Drug Approval; Food
PubMed: 37294583
DOI: 10.1001/jamahealthforum.2023.1313 -
Therapeutic Innovation & Regulatory... Sep 2023The COVID-19 pandemic caused considerable disruption to the development, regulatory evaluation, production, and distribution of medicinal products. Key healthcare... (Review)
Review
Medicinal Product Development and Regulatory Agilities Implemented During the Early Phases of the COVID-19 Pandemic: Experiences and Implications for the Future-An Industry View.
The COVID-19 pandemic caused considerable disruption to the development, regulatory evaluation, production, and distribution of medicinal products. Key healthcare stakeholders were under pressure to develop and review medicinal products to address the health emergency, while preserving the continuity of activities to ensure patient access to other medicinal products. In the light of this challenging situation, the National Regulatory Authorities (NRAs) and the biopharmaceutical industry applied and utilized product development and regulatory agilities to accelerate the development and authorization of safe, effective and quality COVID-19 vaccines and treatments as well as other non-COVID-19 medicinal products. On the basis of the literature review and primary research conducted, this review article gathered insights on experiences and challenges in the use of agilities related to regulatory assessment of initial marketing and post-approval change (PAC) applications, oversight of product manufacturing quality and supply chain continuity, and product development/clinical trial processes during the early phases of the COVID-19 pandemic. Agilities were thus implemented in an emergency context characterized by the lack of medicinal products to help tackle a disease that was devastating for the global public health. This review article concludes that useful lessons can be learned from these insights to improve product development practices and regulatory processes during both normal and health emergency times. Standard regulatory frameworks during normal times can be enhanced by leveraging digitalization, further simplifying and harmonizing requirements, and using reliance mechanisms which can help to increase efficiency in regulatory decision-making regarding medicinal products. During health emergencies, such as a pandemic, maximizing global coordination, collaboration, reliance, and harmonization of regulatory requirements and guidance are important to facilitate the rapid development and assessment of key medicinal products to address the health emergency.
Topics: Humans; COVID-19; Pandemics; COVID-19 Vaccines; Biological Products; Global Health
PubMed: 37266868
DOI: 10.1007/s43441-023-00536-y -
Perspectives in Clinical Research 2023The regulatory approval process of the United States Food and Drug Administration and European Union is the most demanding and challenging worldwide. They have the... (Review)
Review
The regulatory approval process of the United States Food and Drug Administration and European Union is the most demanding and challenging worldwide. They have the provision of the expedited approval pathways, i.e., "Emergency use authorizations" and "Conditional marketing authorizations," respectively, to give approval to novel therapeutics agents during emergency situations. India, firstly formalized the accelerated pathway named "Accelerated Approval Process" as per the New Drugs and Clinical Trials rule 2019 to address unmet medical needs that was implemented by the Central Drug Standard Control Organization to approve the novel therapeutics agents during COVID-19. Hence, our aim is to understand and compare the different emergency approval processes in the world, their underlined claims and conditions with the list of approved products under this concept. All the information collected and analyzed from different official websites of regulatory bodies. In this review, we have enlightened on all these processes with their few approved products.
PubMed: 37325578
DOI: 10.4103/picr.picr_149_22 -
PLoS Neglected Tropical Diseases Jan 2023The availability and accessibility of safe and effective drugs, vaccines, and diagnostics are essential to reducing the immense global burden of neglected tropical... (Review)
Review
The availability and accessibility of safe and effective drugs, vaccines, and diagnostics are essential to reducing the immense global burden of neglected tropical diseases (NTDs). National regulatory authorities, such as the United States Food and Drug Administration (FDA), play an essential role in this effort to ensure access to safe and effective medical products by working within a set of legal frameworks and regulatory functions. However, medical product development for NTDs remains neglected, as combating NTDs is not a viable commercial market for pharmaceutical companies. To spur research and development (R&D) of NTD products, the US government has authorized various programs and policies to engage pharmaceutical companies, many of which provide FDA with the legal authority to implement NTD programs and pathways. Thus, this review provides a clear overview of the various regulatory pathways and programs employed by the FDA to increase the availability of NTD drugs, vaccines, and diagnostics. The review assesses the available information on various regulatory considerations and their impact on NTD product development as a first step in estimating the importance of such programs. Next, findings related to currently approved NTD products through these programs are discussed. Lastly, gaps in NTD R&D are identified and suggestions on how to address these are presented. The available data shows that while such incentive programs are factored into companies' decisions to pursue NTD R&D, approved products for NTDs remains vastly insufficient. Most approved products that utilize these NTD regulatory pathways and programs are overwhelmingly for tuberculosis and malaria-both of which are not considered NTDs by the World Health Organization (WHO). Dedicated efforts are needed to facilitate and accelerate NTD product including employing multiple incentive programs, regular assessment of such programs, and leveraging on public-private partnerships.
Topics: United States; Humans; Global Health; United States Food and Drug Administration; Tropical Medicine; Vaccines; Neglected Diseases; Pharmaceutical Preparations
PubMed: 36634043
DOI: 10.1371/journal.pntd.0011010 -
EFSA Journal. European Food Safety... May 2022The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Italy, and... (Review)
Review
The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Italy, and co-rapporteur Member State, France, for the pesticide active substance oxamyl and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of oxamyl as a nematicide on potato and tobacco (field use), on tomato (permanent greenhouse), on cucurbits (edible and inedible peel), pepper, aubergine and plants nurseries of the above-mentioned crops on soil bed preparation (permanent greenhouse). The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
PubMed: 35600268
DOI: 10.2903/j.efsa.2022.7296