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Drug Regulatory Authority is defined as an authority appointed by the government to administer the granting of marketing authorization/approval of pharmaceutical products and biologicals in a country. It is also called as the Licensing Authority or Marketing Authority. The Drug Regulatory Authority of India is the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare (MOHFW). Pharmaceutical Dossier of India is the major document required for the process of marketing approval of the pharmaceutical products and biologicals in India. Its content and format follows the Common Technical Document (CTD) as set out by the International Conference on Harmonization (ICH). The CTD of India is organized into 5 Modules. The information required under each module is suitably detailed in this article

The International Maritime Organization (IMO) plays a significant role in global marine environmental governance, providing a forum of regulatory oversight for member states. Member states are the main actors of the IMO and exert considerable influence on the process of lawmaking. Among these member states, China is unique due to its multiple identities. There are various factors influencing interests behind China's multiple identities, which fully engage the country in various shipping and maritime trade activities. This article examines China's role in the IMO marine environmental regulatory governance. It identifies the impact of China on global ocean governance and indicates the development and reforms in the global governance system. China enacted the China Ocean Agenda 21 for its strategy of ocean development. Thus, China is the object of study in this examination of empirical research that collects submissions from 2001 to 2020 related to marine environmental governance. The findings reveal that the extent to which China participates in such governance has considerably increased, and although the contribution of China's submissions is still in development, its role in the IMO is no longer merely that of a follower, and the efforts of the country have had a positive influence on the IMO's marine environmental regulatory governance, including its legal instruments.

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.

Examples -- Regulatory conditions -- Divesting and privatizing government powers -- Short-circuiting politics -- Denying procedural rights -- Federalism -- Consent within and beyond the Constitution -- Force and other pressure amid consent -- Irrelevance of force and other pressure -- Regulatory agents.

Frontmatter -- Contents -- Preface -- Introduction -- PART I. The Problem -- 1 Poorly Understood -- 2 Examples -- 3 Regulatory Conditions -- PART II. Unconstitutional Pathway -- 4 Spending -- 5 Divesting and Privatizing Government Powers -- 6 Short-Circuiting Politics -- 7 Denying Procedural Rights -- 8 Federalism -- PART III. Unconstitutional Restrictions -- 9 Consent No Relief from Constitutional Limits -- 10 Consent within and beyond the Constitution -- PART IV. Federal Action -- 11 Varieties of Federal Action -- 12 Force and Other Pressure amid Consent -- 13 Irrelevance of Force and Other Pressure -- PART V. Beyond Consent -- 14 Regulatory Extortion -- 15 Regulatory Agents -- Conclusion -- Notes -- Acknowledgments -- Index

The federal government increasingly regulates by using money and other benefits to induce private parties and states to submit to its conditions. It thereby enjoys a formidable power, which sidesteps a wide range of constitutional and political limits. Conditions are conventionally understood as a somewhat technical problem of "unconstitutional conditions" – those that threaten constitutional rights – but at stake is something much broader and more interesting. With a growing ability to offer vast sums of money and invaluable privileges such as licenses and reduced sentences, the federal government increasingly regulates by placing conditions on its generosity. In this way, it departs not only from the Constitution's rights but also from its avenues of binding power, thereby securing submission to conditions that regulate, that defeat state laws, that commandeer and reconfigure state governments, that extort, and even that turn private and state institutions into regulatory agents. The problem is expansive, including almost the full range of governance. Conditions need to be recognized as a new mode of power – an irregular pathway – by which government induces Americans to submit to a wide range of unconstitutional arrangements. Purchasing Submission is the first book to recognize this problem. It explores the danger in depth and suggests how it can be redressed with familiar and practicable legal tools. ; https://scholarship.law.columbia.edu/books/1310/thumbnail.jpg

A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval. The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are: * The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products * Approaches to clinical trial protocol design and execution * Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products * Key sponsor/FDA meetings and negotiations essential for approval and commercialization Case studies involving such actual combination products as Mylotarg, Herceptin, and HercepTest help you better understand how to implement the author's practical guidelines. References at the end of each chapter enable you to find more information on any stage of the development, manufacturing and approval processes. This book is ideal for researchers, regulators, academics, project managers, and executives involved in the complex process of combination product development. Not only does itoffer a comprehensive guide to the technical aspects of the field, it also integrates all ofthese technical aspects into a unified, effective approach to help ensure a successful,

How do a regulator's decisions depend on the characteristics and strategies of its external clients? We develop a theory of approval regulation in which an uninformed regulator may veto the submission of a better‐informed firm. The firm can perform publicly observable experiments to generate product information prior to submission. We find that when experimentation is short, Type I errors (approving bad products) are more likely for products submitted by firms with lower experimentation costs (larger firms), while Type II errors (rejecting good products) should be concentrated among smaller firms. These comparative statics are reversed when experimentation is long. We perform a statistical analysis on FDA approvals of new pharmaceutical products using two different measures of Type I error. We find consistent support for the counterintuitive hypothesis that, under particular conditions, errors are decreasing in the size of the firm submitting the product.

The Financial Markets (Regulators and KiwiSaver) Bill 2010 proposes to introduce a new regulator to deal with the existing fragmentation of the securities law regulatory regime. Such a move is aimed to restore investor's confidence in the New Zealand financial market. This submission briefly considers the changes that are currently being proposed.I generally support the introduction of this Bill because it addresses key concerns regarding the robustness of the New Zealand regulatory system. The creation of one regulator, the Financial Market Authority (FMA), to deal with securities laws provides a plausible solution to the concerns raised by the final report of the Capital Market Development Taskforce.However there are a few concerns that I have regarding certain provisions in the Bill. These concerns are discussed in the next part of this submission.

Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by original innovator drug manufacturer and adds only bioequivalence studies. Therefore it is very difficult and challenging task to approve a drug by the manufacturing companies, simultaneously submitted in all the regulatory authorities. Regulatory authorities are responsible to ensure the quality, safety, and efficacy including manufacturing, distribution of the drug product. There is lot of challenges for the pharmaceutical industry to development and filling of generic drug application, which can be overcoming by the common format of submission. This is due to the different regulatory procedure of the various countries. Through the international conference on harmonization (ICH) process common technical documents (CTD) has been developed for USA, EU, JAPAN, INDIA AND CANADA. There are few differences in the dossier submission for among these five regions. To development of any generic drug product still we need strategic planning by these regulatory authorities. Keywords: Generic drug, Regulatory authority, Drug development, FDA, ANDA, ICH

This paper looks at the role and design of regulatory reform institutions in developing countries. These institutions are classified into four broad types: 1) regulatory reform units, commonly known in Organization for Economic Cooperation and Development (OECD) countries as oversight bodies for regulatory reform; 2) high-level committees for regulatory reform, established in some countries to leverage support and take decisions at a high political level; 3) advisory and/or advocacy bodies in charge of proposing improvements to the regulatory system by strengthening coordination and consultation mechanisms and by promoting the regulatory reform agenda; and 4) Ad hoc institutions for regulatory reform, established to launch regulatory reform efforts and to work on a single defined task or activity. This paper is divided into the following sections: section one briefly reviews the theoretical debate and literature about the role of institutions in facilitating higher economic growth, focusing in particular on regulatory institutions and their relevance in developing countries; section two discusses the main features of regulatory reform institutions at the center of government, namely regulatory oversight bodies, high level committees, advocacy and/ or advisory bodies and ad-hoc institutions for regulatory reform; and section three identifies the features of these institutions that are considered to be best practice. Section three also identifies and discusses lessons learned and the implications for establishing and operating such institutions in developing country contexts.

BACKGROUND: Biosimilars have been used for 15 years in the European Union (EU), and have been shown to reduce costs and increase access to important biological medicines. In spite of their considerable exposure and excellent safety record, many prescribers still have doubts on the safety and interchangeability of biosimilars, especially monoclonal antibodies (mAbs) and fusion proteins. OBJECTIVES: The aim of this study was to analyse the short- and long-term safety and interchangeability data of biosimilar mAbs and fusion proteins to provide unbiased information to prescribers and policy makers. METHODS: Data on the safety, immunogenicity and interchangeability of EU-licensed mAbs and fusion proteins were examined using European Public Assessment Reports (EPARs) and postmarketing safety surveillance reports from the European Medicines Agency (EMA). As recent biosimilar approvals allow self-administration by patients by the subcutaneous route, the administration devices were also analyzed. RESULTS: Prelicensing data of EPARs (six different biosimilar adalimumabs, three infliximabs, three etanercepts, three rituximabs, two bevacizumabs, and six trastuzumabs) revealed that the frequency of fatal treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation of treatment, serious adverse events (SAEs), and main immune-mediated adverse events (AEs) were comparable between the biosimilars and their reference products. The availability of new biosimilar presentations and administration devices may add to patient choice and be an emerging factor in the decision to switch patients. Analysis of postmarketing surveillance data covering up to 7 years of follow-up did not reveal any biosimilar-specific adverse effects. No product was withdrawn for safety reasons. This is in spite of considerable exposure to biosimilars in treatment-naïve patients and in patients switched from the reference medicinal product to the biosimilar. Analysis of data from switching studies provided in regulatory submissions showed that ...

Legislation governing the health professions has traditionally been drafted with differing regulations and provisions in statute for each profession. This legislation has often been the consequence of seniority or political lobbying, resulting in a disjointed regulatory system, where many professions performed similar procedures. Growing health care awareness by consumers has prompted a greater accountability by the professions. In Ontario, the government addressed this concern by formulating a Health Professions Legislation Review. The review, based upon a new structure to legislate the health professions, required submissions and input from over 200 different groups, including health professions and consumers. The goal was to establish guidelines for the delivery of health care that considered the interests of the public rather than the professions. This impacted directly upon authorized acts, professional self-regulation, shared authority and standards of practice. The ultimate goal being quality assurance. This required attention not only to the methods of delivering health care, but more importantly to measuring its outcome. Chiropractors must recognize that other stakeholders are demanding that their standards be explicitly formulated and be open to public criticism and debate. Standards based upon the "usual and customary practice" are inadequate.