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Journal articles on the topic 'Regulatory Affair'

Author: Grafiati

Published: 21 February 2023

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1

Makwana, Rajdeep G., Kuldeep V. Desai, Vaibhav Kikani, and Maulikkumar D. Vaja. "Regulatory advances and prospects of variation filing for the registered parenteral products in USA and Europe." International Journal of Drug Regulatory Affairs 9, no. 2 (June 16, 2021): 52–65. http://dx.doi.org/10.22270/ijdra.v9i2.470.

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Drug Regulatory Affairs (DRA) is a vital unit in a pharmaceutical company. It is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safety and efficacy in pharmaceuticals, veterinary medicines, medical devices, cosmetics and complementary medicines, healthcare products to individuals around the world. Regulatory affairs (RA) professionals are employed in pharmaceutical industry, government, academic research and clinical institutions. As India is growing very rapidly in pharmaceutical sector, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Today 35 member countries along with 11 candidate countries and 4 international agencies have joined together to create the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to promote a globally accepted GMP. Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for marketing authorization Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and regulatory requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO).

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Vaibhav Subhash Janjal, Snehal Ramdas Dhamodkar, Yogesh Pralhad Jadhao, Sima Baburao Manmode, Anil Keshav Pawar, and Harshada Ravindra Khandelwal. "Recent drug regulatory affair and CTD module progress review for submission of pharmaceuticals product." GSC Biological and Pharmaceutical Sciences 16, no. 3 (September 30, 2021): 200–221. http://dx.doi.org/10.30574/gscbps.2021.16.3.0279.

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Regulatory Affairs (RA), also known as government affairs, is a relatively new profession that arose from governments' desire to protect public health by regulating the safety and efficacy of products such as pharmaceuticals, medical devices, pesticides, veterinary medicines, cosmetics, agrochemicals, and complementary medicines. Pharmaceutical regulatory affairs is concerned with the registration of pharmaceutical goods. All regulatory elements and guidelines connected to product filing are summarized in this evaluation. This study covers the whole CTD and eCTD submission process, as well as the modules that go with it. It also focuses on the key regulatory bodies across the world. Various roles of DRA departments, drug regulatory affairs professionals, the importance of drug affairs in pharmacy curriculum, emerging trends affecting regulatory strategy, regulatory affairs in product management, clinical trials, R&D and the drug approval process in the US, EU, and ROW market trends are discussed.

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Paricharak, Sukanya, Atul Baravkar, Apeksha Masal, Sushma Chougule, Pooja Deshmane, and Sachin Kulkarni. "A comprehensive synopsis on cognizance of Regulatory Affairs in different sectors of Pharmacy." International Journal of Drug Regulatory Affairs 9, no. 4 (December 26, 2021): 20–32. http://dx.doi.org/10.22270/ijdra.v9i4.495.

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A pharmaceutical drug regulatory Affairs is mainly involved in registration process parameters of different pharmaceutical products and new drug application. Regulatory affairs (RA) professionals play vital roles in a pharmaceutical field as, it is related to healthcare products. It provides strategic, operational direction and support for working within regulations to expedite the development of pharmaceutical, biological and medical devices. Also, it is principally concern with safety and efficacy, low risk/high benefit and quality assessment of healthcare drug products throughout the world. Regulatory system of each and every country has different regulatory agencies which govern certification and good manufacturing practices. Regulatory Affairs also has a very specific importance within the formulation and marketing of drug product in pharmaceutical industries. Current abstract reports for the first time and emphasizes on studies concerning awareness and knowledge testing in regulatory affair field by the various pharma professionals. This is completely certified online survey of quiz questionnaire based on important concepts in RA and circulated via google form to different social medias to more than 1000 pharma professionals (Academics, Students, Industrials area). The systematic analysis of received responses reveals awareness and knowledge of the participants about RA in selected pharma professionals. It shows that, participants form industrial area having more knowledge than academics and students. This survey comes out with conclusion that, there is more need to raise RA information sources by the inclusion of this subject in syllabus for academics via various courses to fulfill more RA professional demands in future.

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Chong, Han Chung, Chek Kun Tan, Royston-Luke Huang, and Nguan Soon Tan. "Matricellular Proteins: A Sticky Affair with Cancers." Journal of Oncology 2012 (2012): 1–17. http://dx.doi.org/10.1155/2012/351089.

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The multistep process of metastasis is a major hallmark of cancer progression involving the cointeraction and coevolution of the tumor and its microenvironment. In the tumor microenvironment, tumor cells and the surrounding stromal cells aberrantly secrete matricellular proteins, which are a family of nonstructural proteins in the extracellular matrix (ECM) that exert regulatory roles via a variety of molecular mechanisms. Matricellular proteins provide signals that support tumorigenic activities characteristic of the metastastic cascade such as epithelial-to-mesenchymal (EMT) transition, angiogenesis, tumor cell motility, proliferation, invasion, evasion from immune surveillance, and survival of anoikis. Herein, we review the current understanding of the following matricellular proteins and highlight their pivotal and multifacted roles in metastatic progression: angiopoietin-like protein 4 (ANGPTL4), CCN family members cysteine-rich angiogenic inducer 61 (Cyr61/CCN1) and CCN6, osteopontin (OPN), secreted protein acidic and rich in cysteine (SPARC), tenascin C (TNC), and thrombospondin-1 and -2 (TSP1, TSP2). Insights into the signaling mechanisms resulting from the interaction of these matricellular proteins and their respective molecular partner(s), as well as their subsequent contribution to tumor metastasis, are discussed. In addition, emerging evidences of their promising potential as therapeutic options and/or targets in the treatment of cancer are also highlighted.

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5

Marietta, Morgan. "The Historical Continuum of Financial Illusion." American Economist 40, no. 1 (March 1996): 79–91. http://dx.doi.org/10.1177/056943459604000110.

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Can a clever financier outrun a diligent regulatory system? Are these recurrent excesses controllable, or are they an inevitable feature of economic life? The paper examines a representative history of financial illusions, specifically John Law's 18th century Mississippi Bubble, the original 1920s Ponzi scheme, the Investors Overseas Services (IOS) affair of the 1970s, and the Bank of Credit and Commerce International (BCCI) affair, illustrating the growth over time in the size and complexity of such institutions as well as some of their animating characteristics. If a certain level of entrepreneurial experimentation (deviltry) is a necessary and permanent fixture of the economy, and if we cannot successfully determine between the desirable and the undesirable before outcomes are known, we are faced with continuing growth along the continuum of financial illusion.

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6

Petrova, Iryna. "UNIFICATION OF RECORDS MANAGEMENT IN THE INFORMATION SPECIALIST PROFESSIONAL CULTURE." Bulletin of Mariupol State University. Series: Philosophy, culture studies, sociology 10, no. 20 (2020): 78–86. http://dx.doi.org/10.34079/2226-2830-2020-10-20-78-86.

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The article defines the relevance of the formation of professional culture of the information specialist, caused by the approval of the specialty «Information, library and archival affairs». This event provoked a discussion on the specification of the content of the information affair, as well as an understanding of the need to create a modern, complex and universal model of an information specialist. Based on the analysis of higher education standards in the specialty 029 Information, library and archival affairs of bachelor’s and master’s level of higher education, scientific publications devoted to the training of higher education applicants in this specialty and the professional culture of records managers, professional competencies that should be appropriate in the professional (information specialist) were established. The features of understanding the concept “unification of records management” were considered, its content, ability to implement and use promote the formation of professional culture of the information specialist within the specialty “Information, library and archival affairs”. The current state of the regulatory framework for the organization of documentation of management information and organizing work with official documents in today’s Ukraine as a factor that determines the level of unification of records management and influences the formation of the professional culture of the information specialist were analyzed. Regulation of office work based on rules specified in regulatory legal acts promotes compliance to the principles of quality, efficiency, lack of duplication of operations in working with official documents that directly affects the efficiency of modern Ukrainian authorities, institutions, enterprises, organizations

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7

PHILLIPS, CHARLES D., ANNE-MARIE KIMBELL, CATHERINE HAWES, JANET WELLS, JEAN BADALAMENTI, and MARY JANE KOREN. "It's a family affair: consumer advocacy for nursing-home residents in the United States." Ageing and Society 28, no. 1 (January 2008): 67–84. http://dx.doi.org/10.1017/s0144686x07006435.

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ABSTRACTNursing homes in the United States have for over 40-years been riddled with evidence of poor performance. To combat problems in this industry, state and federal governments developed an elaborate monitoring and regulatory structure. At the same time, an important citizens' movement involving nursing-home consumer advocacy groups (CAGs) came to life. This paper presents the results of a postal survey of 47 active nursing-home consumer advocacy groups. They indicate that the majority of these organisations were started by an individual dissatisfied with the care provided to a family member. The political arena in which these organisations were most active was State legislatures. Though they varied considerably, the average CAG operated on a thin financial margin, largely supported by member contributions and donations. These organisations defined their success in terms of their ability to generate policy changes at the State level. Unfortunately, as they pursued these changes, they often failed to develop the organisational infrastructure necessary to assure the CAGs' continued operation. When CAGs ceased operations, it was in most cases the loss of the organisation's original leader or the cumulative effects of the constant struggle to maintain adequate financial resources.

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8

Perlman, Rebecca L. "The Domestic Impact of International Standards." International Studies Quarterly 64, no. 3 (May 12, 2020): 600–608. http://dx.doi.org/10.1093/isq/sqaa025.

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Abstract Regulation is no longer purely a domestic affair. International standards now exist across a broad range of regulatory arenas, touching on issues that may be central to domestic values, such as the regulation of health, safety, and the environment. Although a number of studies have looked at the domestic impact of globalization more generally, few scholars have evaluated the effects of international standards, specifically. This paper investigates that issue, with an empirical focus on agrochemicals. Using original data on changes to US agrochemical regulations between 1996 and 2015, I evaluate whether and how domestic rules have changed in response to international standards. Contrary to common fears, I find little evidence that international standards primarily act as a ceiling, thereby undermining domestic regulations. Instead, international standards seem to serve as focal points, pulling nations toward leniency as well as toward stringency. These findings not only contribute to the broader literature on the domestic effects of globalization, but they also allay concerns that international standards could act as a regulatory cap, encouraging nations to sacrifice caution for economic gain.

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9

., Afriyanni. "Permasalahan Pelaksanaan Pelayanan Administrasi Terpadu Kecamatan (Paten) Di Kota Padang." Jurnal Pembangunan Nagari 3, no. 1 (June 30, 2018): 97. http://dx.doi.org/10.30559/jpn.v3i1.76.

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PATEN is a new public management centered in the sub-district to improve the quality and bring the service closer to the community. Since Regulatory of minister Affair number 4 in 2010 was declared. The Implementation of PATEN in Indonesia nowdays reach 15 percent. This research aims to identify the problem of impelementation PATEN in Pilot district projects in Padang in order to provide recommendation for PATEN implementation. This study used descriptive qualitative research through observation, documentation and interview in collecting data. The result showed that there are a number of obstacles in the implementation of PATEN namely the delegation of authority, procedures, human resources, limited facilities and infrastructure. For That, it is amust for the Local Government to handle those problems

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Banu, Roxana. "ASSUMING REGULATORY AUTHORITY FOR TRANSNATIONAL TORTS: AN INTERSTATE AFFAIR? A HISTORICAL PERSPECTIVE ON THE CANADIAN PRIVATE INTERNATIONAL LAW TORT RULES." Windsor Yearbook of Access to Justice 31, no. 1 (February 1, 2013): 197. http://dx.doi.org/10.22329/wyaj.v31i1.4321.

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In Tolofson v. Jensen, the Supreme Court of Canada determined that in most cases the law of the place where the tort occurred has exclusive authority to regulate all legal aspects related to it. In developing this choice of law rule, the Supreme Court relied on an analogy between Private International Law and Public International law. This allows Private International Law to claim a structural, neutral function in the distribution of legislative authority in the international realm and to ignore both private law and public law considerations. To best reveal the way in which the Supreme Court injected these limitations into Private International Law by reference to Public International Law, I show the striking similarity between the Supreme Court’s reasoning and several Private International Law writings at the end of the 19th century in Continental Europe. In the context of the extraterritorial tortious activity of multinational corporations, these limitations make Private International Law oblivious to arguments of Corporate Social Responsibility scholars showing that a multinational corporation may legitimately be regulated by the state of its headquarters, even for extraterritorial conduct. Overall, I argue that an overemphasis on legislative authority as a symbol of state sovereignty transforms Private International Law matters generally, and transnational torts in particular, in inter-state affairs, removed from the interests and pleas of the individuals and communities affected by them. Dans l’arrêt Tolofson c. Jensen, la Cour suprême du Canada a décidé que, dans la plupart des cas, la loi du lieu où le délit a été commis régit exclusivement tous les aspects juridiques qui s’y rapportent. Pour établir cette règle du choix de la loi applicable, la Cour suprême s’est fondée sur une analogie entre le droit international privé et le droit international public. Cela permet au droit international privé de réclamer une fonction structurelle et neutre au niveau de la distribution du pouvoir législatif dans le domaine international et d’ignorer tant les considérations de droit privé que les considérations de droit public. Pour mieux illustrer la façon dont la Cour suprême a inséré de telles restrictions dans le droit international privé par renvoi au droit international public, je démontre la similitude frappante entre le raisonnement de la Cour suprême et de nombreux écrits en droit international privé à la fin du 19e siècle en Europe continentale. Dans le contexte des activités délictueuses extraterritoriales des sociétés multinationales, de telles restrictions rendent le droit international privé insensible aux arguments des universitaires prônant la responsabilité sociale des entreprises selon lesquels une société multinationale peut légitimement être régie par l’État où est situé son siège social, même pour sa conduite extraterritoriale. Dans l’ensemble, je fais valoir qu’une trop grande importance accordée au pouvoir législatif comme symbole de la souveraineté étatique transforme les affaires relevant du droit international privé en général et les délits transnationaux en particulier en affaires interétatiques qui ne tiennent pas compte des intérêts et demandes des particuliers et collectivités qu’elles touchent.

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11

Harvey, Ken J. "A review of proposals to reform the regulation of complementary medicines." Australian Health Review 33, no. 2 (2009): 279. http://dx.doi.org/10.1071/ah090279.

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In 2003, the Therapeutic Goods Administration instituted a major recall of products made by Pan Pharmaceuticals Limited. Later that year, an expert committee produced 49 recommendations for complementary medicines reform, many of which were to be implemented by the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA). In 2008, the Pan Pharmaceuticals affair reached some conclusion in the courts, the ANZTPA had been abandoned and the case for reform had intensified. There was widespread and increasing use of complementary medicines yet consumers were often unaware that, unlike conventional medicines, these medicines were not evaluated for efficacy. The justification of this two-tiered regulatory system was that complementary medicines are relatively low-risk products. However low risk does not mean no risk. A number of consumers have been shown to use these products for conditions where there is no evidence of effect, potentially placing them at risk. In addition, promotion often overstates their benefits while minimising and sometimes denying known adverse effects and drug interactions. Complaint procedures are overloaded and the ?sanctions? available do not deter repeat offenders. A number of regulatory reforms have been suggested to overcome these problems; they are reviewed in this paper.

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12

Sethi, Prakash. "The Wal-Mart affair – where implausible deniability is the coin of the realm." Corporate Governance 14, no. 3 (May 27, 2014): 424–51. http://dx.doi.org/10.1108/cg-10-2013-0112.

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Purpose – In the past more than three years, Wal-Mart has been embroiled in incidents of public scandals. In part, they pertain to Wal-Mart’s global strategy of growth and expansion, where the company’s senior managers have been implicated in using illegal bribery and corruption to secure business and to conceal this information from regulatory authorities. Another issue, albeit longer running, has been the incidents of fire and resulting deaths and injuries of hundreds of people, most notably in Bangladesh, but also in other countries where low-skill, low-wage manufacturing predominates, and where foreign multinationals have been accused of condoning and profiting from sweatshop-like exploitation of workers. Design/methodology/approach – The authors use Wal-Mart as a microcosm of corporate conduct which provides a prism through which to examine the exploitation of negative externalities, i.e. engaging in illegal and unethical behavior by using their bargaining power and market control these companies, pressure host countries to condone environmental degradation, violation of country laws in terms of wages, working conditions and operating in sweatshop-like conditions to maximize their profits at the expense of other factors of production, i.e. labor and resources. Findings – The authors contend that Wal-Mart’s unique business model, which focuses on everyday low price, absolute growth and market share expansion by any means possible and everyday low cost, has led to the company’s enormous success since its founding and has made it one of the world’s largest corporations by revenue. At the same time, this model seriously impedes the company’s ability to improve unit-based profit margins and thus forces it to take short cuts in achieving lateral growth and low-cost production. Social implications – The authors also examine in some detail the large gap that exists between Wal-Mart’s pronouncements of the company’s commitment to ethical and socially responsible conduct and its actual business practices. They demonstrate that the company’s communications and claims for ethical conduct are mostly aspirational and fail the test of accuracy, specificity, materiality and verifiability through independent, externally provided integrity assurance. Originality/value – Finally, the authors outline a number of measures that would need to be taken by Wal-Mart, industry groups that depend heavily on outsourcing from low-skill, low-wage countries for their products and host country governments and the governments of Western industrialized nations whose corporations and consumers are the primary beneficiaries of the exploitative sweatshops that fatten their companies’ bottom lines and enrich their denizens with ample amounts of inexpensive goods.

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13

Hoffman, Allison K. "The ACA's Choice Problem." Journal of Health Politics, Policy and Law 45, no. 4 (March 11, 2020): 501–15. http://dx.doi.org/10.1215/03616878-8255445.

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Abstract The Affordable Care Act (ACA) is in many ways a success. Millions more Americans now have access to health care, and the ACA catalyzed advances in health care delivery reform. Simultaneously, it has reinforced and bolstered a problem at the heart of American health policy and regulation: a love affair with choice. The ACA's insurance reforms doubled down on the particularly American obsession with choice. This article describes three ways in which that doubling down is problematic for the future of US health policy. First, pragmatically, health policy theory predicts that choice among health plans will produce tangible benefits that it does not actually produce. Most people do not like choosing among health plan options, and many people—even if well educated and knowledgeable—do not make good choices. Second, creating the regulatory structures to support these choices built and reinforced a massive market bureaucracy. Finally, and most important, philosophically and sociologically the ACA reinforces the idea that the goal of health regulation should be to preserve choice, even when that choice is empty. This vicious cycle seems likely to persist based on the lead up to the 2020 presidential election.

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Salkin, Ira F. "Regulatory Affairs." Applied Biosafety 6, no. 1 (March 2001): 38–39. http://dx.doi.org/10.1177/153567600100600111.

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15

Casci, Tanita. "Regulatory affairs." Nature Reviews Genetics 2, no. 9 (September 2001): 657. http://dx.doi.org/10.1038/35088548.

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16

Ehrmeyer, Sharon S. "Regulatory Affairs." Point of Care: The Journal of Near-Patient Testing & Technology 1, no. 2 (June 2002): 104–6. http://dx.doi.org/10.1097/00134384-200206000-00008.

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17

Zito, Denise R., and Anne A. Hurley. "Regulatory affairs." Cytometry 34, no. 5 (October 15, 1998): 242–43. http://dx.doi.org/10.1002/(sici)1097-0320(19981015)34:5<242::aid-cyto6>3.0.co;2-y.

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18

Hoffman, Paul F. "Big Time." Annual Review of Earth and Planetary Sciences 47, no. 1 (May 30, 2019): 1–17. http://dx.doi.org/10.1146/annurev-earth-053018-060145.

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The Proterozoic Eon was once regarded as the neglected middle half of Earth history. The name refers to early animals, but they did not appear until the eon (2.5–0.54 Ga) was nearly over. Eukaryotic cells and sexual reproduction evolved much earlier in the eon, as did chloroplasts. Molecular dioxygen, the presence of which altered the geochemical behavior of nearly every element essential to life, rose from negligible to near-modern levels, and then plummeted before rising fitfully again. Plate tectonics took on a modern form, and two supercontinents, Nuna and Rodinia, successively congregated and later dispersed. Climate regulatory failures, i.e., Snowball Earth, appear to be a uniquely Proterozoic phenomenon, having occurred twice in rapid succession near the end of the eon (from 717 to 660 Ma and from 650 to 635 Ma) and arguably once near its beginning (ca. 2.43 Ga). Dynamic sea glaciers covered Snowball Earth oceans from pole to pole, and equatorial sublimation drove slow-moving ice sheets on land. Ultimately, the gradual accumulation of CO2 triggered rapid deglaciation and transient greenhouse aftermaths. Physically based and geologically tested, Neoproterozoic Snowball Earth appears to have molecular legacies in ancient bitumens and modern organisms. This is the story of my love affair with an eon that is now a little less neglected.

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Sohail Ahmed and Sujata Bhati. "Role of Regulatory Affairs in Pharmaceutical Industry." International Journal of Scientific Research in Science and Technology, July 10, 2022, 376–80. http://dx.doi.org/10.32628/ijsrst2293140.

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Regulatory affairs in the pharmaceutical Company play an essential function because the pharmaceutical area is growing very fastly and there’s a need of regulatory affairs experts to offer the modern desires of industries for the global competition. A regulatory affair is a career which acts as the interface among pharmaceutical industries and authorities government throughout the international. The purpose of the regulatory affairs expert is the safety of human fitness, ensuring safety, efficacy, and best of pills, ensuring appropriateness and accuracy of product facts. This recent article discusses the evolution of Regulatory Affairs, its function withinside the pharmaceutical company and its involvement for the implementation of regulatory tips which enhance the boom of the company.

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20

Hagavane Suraj E., Pacharne Gauravi K., Gund Akshada L., and Walkunde Anushka B. "Regulatory Affairs and its Role in Medical Devices." International Journal of Advanced Research in Science, Communication and Technology, June 21, 2022, 72–75. http://dx.doi.org/10.48175/ijarsct-4981.

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Regulatory affair is comparatively new profession which developed from the purpose of governments to protect public health by governing the quality, safety and efficacy of product within regulated industries. Regulatory affairs in the pharmaceutical industry play an important role as the pharmaceutical sector is rising very rapidly and there is want of regulatory affairs professionals to provide the current needs of industries for the global competition. Regulatory affairs professionals serve a critical function throughout a medical device’s product lifecycle-leading pre market strategy, drafting regulatory submissions, and ensuring post market compliance. The medical device industry plays a key role in the health care ecosystem by providing innovative solutions that improve patient outcomes. Every company seeks to innovate, whether through iterative updates to existing technology or by developing new devices that could offer a more effective treatment to a particular disease or condition. Many countries throughout the world have their own medical device regulations, however, and regulatory affairs is required to understand the difference in global regulatory requirements to ensure that new products can be marketed. The global regulatory landscape is always changing, so successful regulatory affairs teams follow global trains and are aware of new regulations or programs.

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Chikobava, Elene, and Irma Beridze. "The Challenges to be a Regulatory Affair Associate: Day-To-Day Questions on How to Reach Consensus between Manufacturers of Pharmaceutical Products and Government Regulatory Authorities." Pharmacovigilance and Pharmacoepidemiology, February 21, 2020, 37–40. http://dx.doi.org/10.33805/2638-8235.114.

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The modern pharmaceutical industry is one of the main branches in the healthcare segment and is considered to be the most highly regulated industries worldwide. The regulation is provided by a specialist, named Regulatory Affairs Manager (syn.: Regulatory Affairs Executive or Regulatory Affairs Associate), involved in authorization process of pharmaceutical products. When person graduates from University with medical, pharmaceutical or even chemical diploma, he/she never thinks about professional career as a Regulatory Affairs Manager, because this specialty is new, about 40 years old. What is a Regulatory Affairs Associate’s duty? One category-Regulatory Affairs Associate inside the manufacturing office, whose duty is to prepare registration dossier based on the process of artworks and Patient Information Leaflet preparation, prior to completing Common Technical Document (CTD) format dossier; other category (national regulatory affairs Associate)-are those who are ensuring mediation between Manufacturer and Government Regulatory Authorities. Regardless of differences of each Government requirement for dossier registration, the main task of each Regulatory Affairs Associate is to prepare Dossier for submission which will pass successful registration. For this purpose, the National Regulatory Affairs Associate should ensure that manufacturer/Marketing Authorization Holder (MAH)’s dossier is complete and in line with different documentation requirements, following the national requirements and in case such requirement don’t exist-with the guidelines of the World Health Organization (WHO) and International Council for Harmonization (ICH). On the other hand, National Regulatory Affairs Associate is working with National Regulatory Affairs officers to correct and align deficiencies in documentation in accordance with the National requirements. Each drug as a living organism (innovative drugs even have birthdays), which is subject to many changes reflected in the registration dossier: whether in its pharmaceutical part (composition, production process, stability etc.,) or pharmacological (therapeutic indications, side effects and others), as a consequence the Regulatory Affairs Manager is constantly involved in registration of an infinite number of Variations. The main goal of Regulatory structures-both governmental and private-is to ensure the safety, quality and efficacy of medicines.

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Vimolmangkang, Sornkanok, Dolly Rani, Naruemon Prestwong, Chayanis Sutcharitchan, and Duangkamol Pakdeesattayapong. "Revisiting some overlooked registered Thai traditional medicine preparations: an alert to a regulatory affair." Bulletin of the National Research Centre 46, no. 1 (July 11, 2022). http://dx.doi.org/10.1186/s42269-022-00903-z.

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Abstract Objective This study evaluated the heavy metal identity and content of registered Thai Traditional medicine (TTM) preparations in Thailand to ensure consumer safety. Methods Both qualitative and quantitative information about the elemental composition of the heavy metal content in each TTM crude drug and the heavy metal content in some registered TTM preparations in Thailand was performed. Seven kinds of mineral-based TTM crude drugs, namely realgar, orpiment, Chinese powder, Sen, vermilion, natural vermilion, and cinnabar, were analyzed with X-ray diffraction and scanning electron microscopy and energy-dispersive spectroscopy techniques to determine the type of metal and elemental composition to confirm their chemical formulas. Furthermore, the number of heavy metals, such as arsenic (As), lead (Pb), and mercury (Hg), was in three samples of realgar-containing preparations; one sample of Sen-containing preparation, and eight samples of cinnabar-containing preparations. Heavy metals were determined with inductively coupled plasma-optical emission spectrometry. Results It was observed that realgar and orpiment consisted of arsenic sulfide (AsS) and arsenic trisulfide (As2S3), respectively. Both crude drugs contained approximately 50% of As. Vermilion, natural vermilion, and cinnabar consisted of mercuric sulfide (HgS), with Hg accounting for approximately 66%. Sen consisted of Pb (II, IV) oxide (Pb3O4) with an approximate Pb percentage of 80%. However, Pb was absent in Chinese powder and consisted mainly of calcium carbonate (CaCO3). A traditional detoxification procedure can reduce the amount of As and Hg in processed crude drugs by at least 20%. Conclusions Pb was higher in some TTM preparations, and no CaCO3 was detected in Chinese powder. Our results raise concerns on both safety and efficacy to consumers and alert public health policymakers that they should implement regulations so that the quality (authenticity) and quantity of elemental medicine used in traditional medicine are correctly labeled and within permissible limits to prevent threats to consumers.

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Barkat, Md Abul, Anjali Goyal, Harshita Abul Barkat, Mohammad Salauddin, Faheem Hyder Pottoo, and Esra T. Anwer. "Herbal Medicine: Clinical Perspective & Regulatory Status." Combinatorial Chemistry & High Throughput Screening 23 (November 10, 2020). http://dx.doi.org/10.2174/1386207323999201110192942.

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Abstract:: Herbal medicines pays an important in treating the vaious diseases mainly due to the their potentially high therapeutic values and also due to the better acceptance of vaioruspatient under different health complications. The herbal medicine practice involves use of part of plant, entire plant or the selectctive isolated phytomedicineand the use and practices based on these has its pros and cons and has been greatly affected during the dawn. The search of new drugs during scientific era revives the interest in discovery of herbal drugs from different natural resources during 20th century. The present modern healthcare system invovlves utilization drugs and 50% of them are of ofnaural origin. Herbal drug disocovery found to be highly costly affair with low success rate and it hinders the further progress in utilizting the phytomedicine in treating the various deseases. But in recent years there is an increase in the search interest of herbal drugs mainly by the pharmaceutical industry and those invoves in the search of novel drugs from the herbs. Discovery of such new novel phytomedicines has to overcomes various challenges in indentification of active extracts and their toxicity, advereffects, herb drug interaction and importantly their regulatory requirments. The present review mainly focused on the history of herbal medicine, current clinical perspective, pharmaceutical, and regulatory challenges as well as its clinical presentation. Moreover, problems encountered in drug discovery from herbal resources and its possible solutions are delineated.

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Jimeno, Sonia, Fernando R. Balestra, and Pablo Huertas. "The Emerging Role of RNA Modifications in DNA Double-Strand Break Repair." Frontiers in Molecular Biosciences 8 (April 29, 2021). http://dx.doi.org/10.3389/fmolb.2021.664872.

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The correct repair of DNA double-strand breaks is essential for maintaining the stability of the genome, thus ensuring the survival and fitness of any living organism. Indeed, the repair of these lesions is a complicated affair, in which several pathways compete for the DNA ends in a complex balance. Thus, the fine-tuning of the DNA double-strand break repair pathway choice relies on the different regulatory layers that respond to environmental cues. Among those different tiers of regulation, RNA modifications have just emerged as a promising field.

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Chakraborty, Mainak. "Regulatory Affairs in Pharmaceutical Industry." Pharmaceutical Drug Regulatory Affairs Journal 5, no. 1 (2022). http://dx.doi.org/10.23880/pdraj-16000129.

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Regulatory Affairs in pharmaceutical industries is a one of the most critical job. Regulatory Affairs is mainly concerned about the lifecycle of healthcare product and it gives tactical, strategic and operation advice to work within regulation to develop safe and effective healthcare product around the World. The work of Regulatory Affairs to nurture and implementing a strategy to guarantee the collective efforts of the drug development team, so that the drug get approval from global regulatory authorities. Regulatory Affairs is a catchy career choice for graduate student from scientific background. Regulatory Affairs is a multitasking job. This job is suitable for those people who enjoys communicating with people, enjoys team work and want to expand their knowledge in pharmaceutical sector. Regulatory Affairs is a very rewarding job. A person who want pursue their job in Regulatory Affairs should have knowledge about ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use).

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Xavier Lacasse, François. "Regulatory Affairs: More than Guidance and Guidelines." Pharmaceutical Drug Regulatory Affairs Journal 5, no. 1 (2022). http://dx.doi.org/10.23880/pdraj-16000135.

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"Regulatory Affairs." Biotechnology Law Report 21, no. 5 (October 2002): 437–40. http://dx.doi.org/10.1089/07300310260395740.

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"Regulatory Affairs." Biotechnology Law Report 21, no. 4 (August 2002): 336–38. http://dx.doi.org/10.1089/073003102760255298.

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"Regulatory Affairs." Biotechnology Law Report 21, no. 6 (December 2002): 558–67. http://dx.doi.org/10.1089/073003102761697945.

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"Regulatory Affairs." Nature Reviews Drug Discovery 8, no. 3 (March 2009): 255. http://dx.doi.org/10.1038/nrd2843.

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"Regulatory Affairs." Biotechnology Law Report 32, no. 4 (August 2013): 259. http://dx.doi.org/10.1089/blr.2013.9869.

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"Regulatory affairs." Current Opinion in Biotechnology 7, no. 3 (June 1996): 356. http://dx.doi.org/10.1016/s0958-1669(96)80044-9.

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"Regulatory Affairs." Food and Bioproducts Processing 78, no. 4 (December 2000): 221–23. http://dx.doi.org/10.1205/09603080051065340.

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"Regulatory Affairs." Food and Bioproducts Processing 78, no. 1 (March 2000): 61–62. http://dx.doi.org/10.1205/096030800532635.

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"Regulatory Affairs." Food and Bioproducts Processing 78, no. 2 (June 2000): 108–13. http://dx.doi.org/10.1205/096030800532743.

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"Regulatory Affairs." Food and Bioproducts Processing 78, no. 3 (September 2000): 173–76. http://dx.doi.org/10.1205/096030800532842.

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"Regulatory Affairs." Food and Bioproducts Processing 79, no. 1 (March 2001): 70–72. http://dx.doi.org/10.1205/09603080151123380.

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"Regulatory Affairs." Food and Bioproducts Processing 79, no. 2 (June 2001): 138–39. http://dx.doi.org/10.1205/096030801750286203.

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"Regulatory Affairs." Food and Bioproducts Processing 79, no. 3 (June 2001): 192–94. http://dx.doi.org/10.1205/096030801750425316.

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"Regulatory Affairs." Food and Bioproducts Processing 79, no. 4 (December 2001): 255–57. http://dx.doi.org/10.1205/096030801753252342.

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"Regulatory Affairs." Food and Bioproducts Processing 80, no. 4 (December 2002): 342–44. http://dx.doi.org/10.1205/096030802321154899.

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"Regulatory Affairs." Food and Bioproducts Processing 80, no. 2 (June 2002): 139–41. http://dx.doi.org/10.1205/09603080252938799.

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"Regulatory Affairs." Food and Bioproducts Processing 80, no. 1 (March 2002): 61–63. http://dx.doi.org/10.1205/096030802753479142.

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"Regulatory Affairs." Food and Bioproducts Processing 80, no. 3 (September 2002): 215–17. http://dx.doi.org/10.1205/096030802760309232.

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"Regulatory Affairs." Food and Bioproducts Processing 81, no. 2 (June 2003): 149–50. http://dx.doi.org/10.1205/096030803322088297.

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"Regulatory Affairs." Food and Bioproducts Processing 81, no. 3 (September 2003): 281–83. http://dx.doi.org/10.1205/096030803322438063.

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"Regulatory Affairs." Food and Bioproducts Processing 81, no. 4 (December 2003): 336–38. http://dx.doi.org/10.1205/096030803322756420.

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"Regulatory Affairs." Food and Bioproducts Processing 81, no. 1 (March 2003): 69–71. http://dx.doi.org/10.1205/096030803765208706.

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"Regulatory Affairs." Food and Bioproducts Processing 82, no. 2 (June 2004): 177–78. http://dx.doi.org/10.1205/0960308041614945.

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"Regulatory Affairs." Food and Bioproducts Processing 82, no. 1 (March 2004): 96–97. http://dx.doi.org/10.1205/096030804322985371.

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