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537 articles for “regulatory”
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Regulatory Approach for Safe Long-term Storage –Human Intrusion Scenario
Abstract: Storage is a necessary step in the management of radioactive waste. In recent years, storage step is extended; serious consideration has been given, in some countries to the use of storage as a long-term management option. This option, in particular is considered for spent fuels, high-level, and long-lived wastes. Reactor production of Mo-99 generated high and lived radioactive wastes. These wastes require complex and expensive facilities for extensive handling, separation, …
Published in Journal of Nuclear Engineering & Technology · Vol. 1, Issue 2-3, 2011 Read article
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A Review on the Regulatory Study for Implementation of Schedule-M Amendments in Pharmaceutical Industries in India
Abstract: A major regulatory change in pharmaceutical manufacturing industry in India is the introduction of the updated Schedule M (2023–2024). The aims to compliance the country's Good Manufacturing Practices (GMP) with international quality standards. The review evaluates the Schedule M amendments implementation strategies, industrial impact and regulatory relevance. Legislative texts, official notices, WHO GMP reports, ICH guidelines, guidance documents of CDSCO and peer-reviewed literature were all explored as part of the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 13, Issue 2, 2026 Read article
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Key Regulatory Requirements and Guidelines for the Registration of a Drug in Canada
Abstract: Drug product registration is an important step in the process of a drug development from raw material to finished product to making it available to the public. Drug regulatory authorities play an important role in this process. Health Canada is the regulatory authority in Canada which manages the drug submission and approval of drug product in Canada. The guidelines from the Food and Drugs Act and Regulations for drug products …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 2, Issue 2, 2015 · pp. 28–37 Read article
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Regulatory Requirements for Pharmaceutical Product Registration in UAE
Abstract: Over the past decade, the healthcare industry in the United Arab Emirates (UAE) has experienced remarkable growth, positioning itself as the second-largest healthcare industry in the Middle East, trailing only Saudi Arabia. Recognizing the significance of healthcare, the UAE government has prioritized its development and actively promoted it as part of the national development plan. The Ministry of Health (MOH) has played a crucial role in this endeavor by allocating …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 1, 2024 · pp. 1–7 Read article
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Regulatory Requirements for Pharmaceutical Product Registration in Zambia
Abstract: There is a significant burden of diseases in Zambia and its neighboring countries, such as malaria, HIV/AIDS, and other ailments. These health challenges necessitate a high consumption of pharmaceutical products. Currently, the majority of essential health drugs in Zambia are imported from outside of Africa. This reliance on external sources presents an opportunity for new investments in the local manufacturing of pharmaceutical products. Although Zambia may not be the largest …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 2, 2024 · pp. 33–41 Read article
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FERMENTED FOODS: FUNCTIONAL AND REGULATORY INSIGHTS
Abstract: Traditional fermented edible products have been in the food industry since ancient times. Today, the fermentation process has become most common in the health food industry. Due to the microorganisms present in fermented food products, the health benefits have been helpful in many ways. Fermentation helps in enhancing gut health, blood sugar, blood pressure, and brain health. These food products also play a major role in lowering cancer risk and …
Published in Research and Reviews : A Journal of Biotechnology · Vol. 15, Issue 3, 2025 · pp. 1–10 Read article
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Nano-Tech and Indian Regulatory Regime: A Review
Abstract: Nano-technology is still a niche field in the realm of science and technology, however its potential in terms of increased efficacy and effectiveness cannot and should not be taken away. In a world driven by advancements in innovation and technology, like any other scientific advancement nano-tech brings into the light question about use and abuse and therefore it becomes imperative to ask ourselves that whether or not we are fully …
Published in Nano Trends – A Journal of Nano Technology & Its Applications · Vol. 22, Issue 1, 2020 · pp. 15–18 Read article
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Regulatory Requirement for Pharmaceutical Marketing in USA, EU and GCC: A Comparison
Abstract: The Gulf Cooperation Council (GCC) pharmaceutical are known to be a semi-regulated market when compared with European Union (EU) and Unites States of America (USA) drug regulatory market. Product registration in GCC was challenging task in comparison to EU and USA due to lack of proper harmonised guidelines and diversity in registration procedure. The six GCC member states namely Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates have …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 1, Issue 3, 2014 · pp. 16–21 Read article
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Cannabinoids as Nutritional Supplements: Exploring The Potential Health Benefits and Regulatory Landscape
Abstract: Cannabinoids, the bioactive compounds derived from the Cannabis sativa plant, have garnered increasing interest for their potential role as nutritional supplements. This abstract provides a succinct overview of cannabinoids as nutritional supplements. This review delves into the multifaceted aspects of cannabinoids, particularly their interaction with the endocannabinoid system (ECS) and their potential health benefits. The exploration begins by elucidating the intricate relationship between cannabinoids and the ECS, a vital regulatory …
Published in Emerging Trends in Metabolites · Vol. 1, Issue 1, 2024 · pp. 48–53 Read article
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Overview of Regulatory Scenario on Switch Mechanism for Over The Counter class in European Countries, and Assessing its Effectiveness on Self-Care Management
Abstract: Short term self-medication has tremendous power in lowering the burden of medical practitioners. Responsible self-care allows everyone to maintain their healthcare status with limited involvement in obtaining guidance from other health care practitioners such as pharmacists, etc. Although most of the EU countries have adopted to formal procedure of switch to change the class from Rx to OTC category, still there are chances to harmonize the mechanism of switch process …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 2, 2017 · pp. 17–23 Read article
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Switch Movement: Overview of Various Key Attributes on Regulatory Scenario of OTC Legislations in U.S.
Abstract: The Rx-to-OTC switch was a phenomenal success in USA, which was based on risk/benefit ratio of all scientific evidences in collaboration with FDA, manufacturer and consumers. Different surveys speak about the success stories of Rx-to-OTC movement as consumers experience the benefit from self-care in terms of empowerment, convenience, savings of money and time, etc. OTC perspective of scientific and regulatory bodies is based upon a valid procedure and just not …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 2, 2017 · pp. 24–31 Read article
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A Research on the Additives and Regulatory Requirements for Pediatric Formulation
Abstract: These days, pediatric considerations are incorporated early on in the creation of new medications. The guidelines and policies of European drug regulatory bodies served as the foundation for our investigation. The review comprehensively outlines excipients commonly found in pediatric medicine formulations. It identifies potentially harmful compounds flagged by scientific literature, stressing the necessity of rigorous safety checks, often involving toxicity studies. Excipients included in pediatric databases, like the STEP database, …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 1, 2024 · pp. 28–45 Read article
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India’s Traditional Medicine Trade (2015–2024): Trends, Regulatory Landscape, and Policy Directions for Sustainable Growth
Abstract: India is a major global supplier of traditional medicine products – including Ayurvedic, Unani, Siddha, homeopathic, and other herbal and plant-based formulations – yet exports continue to face challenges arising from regulatory divergence, heterogeneous quality-control requirements across markets, and raw-material supply constraints linked to biodiversity pressure and fragmented value chains. This paper systematically analyzes India’s import-export patterns for traditional medicine between 2015 and 2024, maps the regulatory landscape (DGFT, Drugs, …
Published in Research & Reviews : A Journal of Unani, Siddha and Homeopathy · Vol. 13, Issue 1, 2026 · pp. 13–18 Read article
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Food Packaging Chemicals and Human Health: Molecular Toxicity, Exposure Pathways, and Regulatory Perspectives
Abstract: Food packaging plays a vital role in preserving food quality, extending shelf life, and ensuring safe transportation. However, increasing evidence indicates that chemicals from packaging materials can migrate into food during processing, storage, and consumption, resulting in chronic human exposure. Several food packaging chemicals, including bisphenols, phthalates, per- and polyfluoroalkyl substances (PFAS), styrene, heavy metals, and non-intentionally added substances (NIAS), have emerged as important xenobiotics due to their potential adverse …
Published in Research and Reviews: A Journal of Toxicology · Vol. 16, Issue 2, 2026 Read article
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Wastewater Treatment Techniques, Quality Monitoring, and Compliance with Regulatory Standards in Nigeria
Abstract: Innovative wastewater treatment techniques, recycling systems, circular economy, and quality monitoring and enforcement of regulatory standards are vital for sustainable urban water development. This study offers a thorough analysis and review of the literature on wastewater treatment methods in Nigeria, spanning from traditional approaches to cutting-edge technologies like membrane bioreactors, trickling filters, activated sludge systems, anaerobic digesters, and constructed wetlands. It also investigates deeper into the existing quality monitoring systems, …
Published in Journal of Water Pollution & Purification Research · Vol. 13, Issue 2, 2026 · pp. 23–35 Read article
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Drug Product Registration and Regulatory Requirements in Australia (TGA)
Abstract: The present study aims to understand the drug product regulatory requirements and drug product registration process in Australia. Therapeutic Goods Administration (TGA) is the regulatory authority for Australia and is responsible for regulating medicines and medical devices. However, as known, each country has its own regulatory agency to enforce the rules and regulate the guidelines to market a drug substance and drug product. To get authorization of marketing of drug …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 2, Issue 1, 2015 · pp. 7–15 Read article
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Regulatory Requirements for Registration of Generic Drug Product in Brazil
Abstract: Drug Product Registration is a procedure of expertise of the pharmaceutical products quality, efficacy and safety by Regulatory Authority. This present study focuses mainly on the marketing regulatory requirements for filing a generic product, the regulations that are applicable for the Pharmaceutical drug products. The emergence of various formats has enabled the manufacturers of the drug product, to easily gain access into various markets and thus, able to place their …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 2, Issue 2, 2015 · pp. 38–45 Read article
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Regulatory Concerns in Imports, Exports and Registration of Drugs and Dietary Supplements
Abstract: The main aim of this article was to study the various pharmaceutical products registration processes, regulations and requirements by the Indian Regulatory Authorities. The study emphasizes on the challenges faced by stakeholders entering into the Indian market without difficulty by demonstration of strategy arrived from the established guidelines, regulations and expert opinion. The study was undertaken to identify the challenges in biosimilar developments and dietary supplements and to evaluate the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 1, 2017 · pp. 13–22 Read article
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AI-Driven DevSecOps Automation: An Intelligent Framework for Continuous Cloud Security and Regulatory Compliance
Abstract: Cloud-native systems, microservices, and infrastructure-as-code (IaC)–oriented CI/CD pipelines have accelerated the pace of software delivery, yet they have also introduced new layers of operational complexity and widened the overall security exposure of modern applications. Traditional DevSecOps workflows still depend heavily on isolated scanners, manual reviews, and static governance processes that are not well-suited for the elasticity and constant change characteristic of multi-cloud environments. To address these limitations, this paper introduces …
Published in Journal of Artificial Intelligence Research & Advances · Vol. 13, Issue 1, 2025 · pp. 01–15 Read article
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Building a Resilient Climate Regulatory Ecosystem for Nigeria
Abstract: Terrestrial ecosystems, which store more carbon than the atmosphere, are vital to influencing carbon dioxide-driven climate change. Climate and land-use change are critical and interlinked components of the Carbon budget in human-dominated landscape, using the InVEST model maps of land use and stocks in four Carbon pools (aboveground biomass, belowground biomass, soil, dead organic matter) are used to estimate the amount of Carbon currently stored in the landscape and the …
Published in Journal of Alternate Energy Sources & Technologies · Vol. 11, Issue 2, 2020 · pp. 46–62 Read article