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Pharmaceuticals And Medical Devices Agency
The (PhMDA) is an Independent Administrative Institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. It is similar in function to the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the United Kingdom or the Food and Drug Administration in the Philippines. The PhMDA has been eCTD compliant at least since December 2017. Tasks Among other things, the agency is tasked with the following: * Drug and medical device testing: ** Scientific review of market authorization applications based on Japanese pharmaceutical law ** Advice in clinical trials or in the preparation of dossiers for the registration procedure (New Drug Applications (NDA)) ** Inspection and conformity assessment of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Practice Systems and Programs (GPSP) ** Auditing of manufacturers to ensure they conform to Good Manufacturin ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Japanese Language
is spoken natively by about 128 million people, primarily by Japanese people and primarily in Japan, the only country where it is the national language. Japanese belongs to the Japonic or Japanese- Ryukyuan language family. There have been many attempts to group the Japonic languages with other families such as the Ainu, Austroasiatic, Koreanic, and the now-discredited Altaic, but none of these proposals has gained widespread acceptance. Little is known of the language's prehistory, or when it first appeared in Japan. Chinese documents from the 3rd century AD recorded a few Japanese words, but substantial Old Japanese texts did not appear until the 8th century. From the Heian period (794–1185), there was a massive influx of Sino-Japanese vocabulary into the language, affecting the phonology of Early Middle Japanese. Late Middle Japanese (1185–1600) saw extensive grammatical changes and the first appearance of European loanwords. The basis of the standard dialect moved f ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Practice Systems And Programs
In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, philosophy, and religion. The specific meaning and etymology of the term and its associated translations among ancient and contemporary languages show substantial variation in its inflection and meaning, depending on circumstances of place and history, or of philosophical or religious context. History of Western ideas Every language has a word expressing ''good'' in the sense of "having the right or desirable quality" ( ἀρετή) and ''bad'' in the sense "undesirable". A sense of moral judgment and a distinction "right and wrong, good and bad" are cultural universals. Plato and Aristotle Although the history of the origin of the use of the concept and meaning of "good" are diverse, the notable discussions of Plato and Aristotle o ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Independent Administrative Institutions Of Japan
Independent or Independents may refer to: Arts, entertainment, and media Artist groups * Independents (artist group), a group of modernist painters based in the New Hope, Pennsylvania, area of the United States during the early 1930s * Independents (Oporto artist group), a Portuguese artist group historically linked to abstract art and to Fernando Lanhas, the central figure of Portuguese abstractionism Music Groups, labels, and genres * Independent music, a number of genres associated with independent labels * Independent record label, a record label not associated with a major label * Independent Albums, American albums chart Albums * ''Independent'' (Ai album), 2012 * ''Independent'' (Faze album), 2006 * ''Independent'' (Sacred Reich album), 1993 Songs * "Independent" (song), a 2007 song by Webbie * "Independent", a 2002 song by Ayumi Hamasaki from '' H'' News and media organizations * ''The Independent'', a British online newspaper. * ''The Malta Independent'', a Malte ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Agencies For Drug Regulation
National may refer to: Common uses * Nation or country ** Nationality – a ''national'' is a person who is subject to a nation, regardless of whether the person has full rights as a citizen Places in the United States * National, Maryland, census-designated place * National, Nevada, ghost town * National, Utah, ghost town * National, West Virginia, unincorporated community Commerce * National (brand), a brand name of electronic goods from Panasonic * National Benzole (or simply known as National), former petrol station chain in the UK, merged with BP * National Car Rental, an American rental car company * National Energy Systems, a former name of Eco Marine Power * National Entertainment Commission, a former name of the Media Rating Council * National Motor Vehicle Company, Indianapolis, Indiana, USA 1900-1924 * National Supermarkets, a defunct American grocery store chain * National String Instrument Corporation, a guitar company formed to manufacture the first resonator g ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical And Health Organizations Based In Japan
Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness. Contemporary medicine applies biomedical sciences, biomedical research, genetics, and medical technology to diagnose, treat, and prevent injury and disease, typically through pharmaceuticals or surgery, but also through therapies as diverse as psychotherapy, external splints and traction, medical devices, biologics, and ionizing radiation, amongst others. Medicine has been practiced since prehistoric times, and for most of this time it was an art (an area of skill and knowledge), frequently having connections to the religious and philosophical beliefs of local culture. For example, a medicine man would apply herbs and say prayers for healing, or an anci ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Blood Transfusion
Blood transfusion is the process of transferring blood products into a person's circulation intravenously. Transfusions are used for various medical conditions to replace lost components of the blood. Early transfusions used whole blood, but modern medical practice commonly uses only components of the blood, such as red blood cells, white blood cells, plasma, clotting factors and platelets. Red blood cells (RBC) contain hemoglobin, and supply the cells of the body with oxygen. White blood cells are not commonly used during transfusion, but they are part of the immune system, and also fight infections. Plasma is the "yellowish" liquid part of blood, which acts as a buffer, and contains proteins and important substances needed for the body's overall health. Platelets are involved in blood clotting, preventing the body from bleeding. Before these components were known, doctors believed that blood was homogeneous. Because of this scientific misunderstanding, many patients died b ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Management System
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Manufacturing Practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality managemen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Laboratory Practice
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health (including pharmaceuticals) through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests. GLP was first introduced in New Zealand and Denmark in 1972, and later in the US in 1978 in response to the Industrial BioTest Labs scandal. It was followed a few years later by the Organization for Economic Co-operation and Development (OECD) Principles of GLP in 1992; the OECD has since helped promulgate GLP to many countries. GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of products in development (including pharmaceuticals) for people, animals, and the environment. GLP, a data and opera ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Independent Administrative Institution
An Incorporated Administrative Agency (独立行政法人, ''Dokuritsu gyōsei hōjin'' or ''Dokugyo'' in abbreviation) is a type of legal corporation formulated by the Government of Japan under the Act on General Rules for Incorporated Administrative Agencies (Act no. 103 of 1999, revised in 2014). The independent agencies are not under the National Government Organization Act that provides for the ministries and agencies of Japan. Originally proposed by the Administrative Reform Council, the independent agencies are created based on the concept of separating the ministries and agencies of the government into planning functions and operation functions. Planning functions remain within government-based ministries and agencies while operating functions are transferred to the independent agencies. Incorporated Administrative Agencies utilize management methods of private-sector corporations and are given considerable autonomy in their operations and how to use their given budgets. I ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Clinical Practice
Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how cl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ECTD
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). History Version 2.0 of eCTD – an upgrade over the original CTD – was finalized on February 12, 2002, and version 3.0 was finalized on October 8 of the same year. , the most current version is 3.2.2, released on July 16, 2008. A Draft Implementation Guide for version 4.0 of eCTD was released in August 2012. However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 Draft specifications and guides were issued in April 2016 by the ICH and the FDA, followed by a May 13 ICH "teleconference to discuss the guidance and any questions and clarifications needed." U. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
