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Sakigake (drug Designation)
Sakigake (さきがけ, lit. "pathfinder", "harbinger") is a drug designation by the Pharmaceuticals and Medical Devices Agency, the pharmaceuticals regulator of Japan. It was designed to provide easier access to novel advanced treatments. It is analogous to the Regenerative Medicine Advanced Therapy designation in the United States and the Advanced Therapy Medicinal Product designation in the European Union. History The Sakigake designation was first announced as a pilot by the Ministry of Health, Labour and Welfare The is a cabinet level ministry of the Japanese government. It is commonly known as in Japan. The ministry provides services on health, labour and welfare. It was formed with the merger of the former Ministry of Health and Welfare or and the ... on 17 June 2014. The designation system is part of a wider strategy, also named Sakigake, to promote R&D and improve access to new pharmaceuticals. The Pharmaceutical & Medical Device Act Amendments of 2019, which ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 Manufactu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Japan
Japan ( ja, 日本, or , and formally , ''Nihonkoku'') is an island country in East Asia. It is situated in the northwest Pacific Ocean, and is bordered on the west by the Sea of Japan, while extending from the Sea of Okhotsk in the north toward the East China Sea, Philippine Sea, and Taiwan in the south. Japan is a part of the Ring of Fire, and spans an archipelago of 6852 islands covering ; the five main islands are Hokkaido, Honshu (the "mainland"), Shikoku, Kyushu, and Okinawa. Tokyo is the nation's capital and largest city, followed by Yokohama, Osaka, Nagoya, Sapporo, Fukuoka, Kobe, and Kyoto. Japan is the eleventh most populous country in the world, as well as one of the most densely populated and urbanized. About three-fourths of the country's terrain is mountainous, concentrating its population of 123.2 million on narrow coastal plains. Japan is divided into 47 administrative prefectures and eight traditional regions. The Greater Tokyo Ar ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regenerative Medicine Advanced Therapy
Regenerative Medicine Advanced Therapy (RMAT) is a designation given by the Food and Drug Administration to drug candidates intended to treat serious or life-threatening conditions under the 21st Century Cures Act. A RMAT designation allows for accelerated approval based surrogate or intermediate endpoints. RMAT goes beyond breakthrough therapy features by allowing for accelerated approval of drugs based on surrogate endpoints. A surrogate endpoint is a biomarker that substitutes for a direct endpoint, such as clinical benefit. Legal background Section 3033 of the 21st Century Cures Act introduces section 506(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that allows for the designation of certain therapies as a 'regenerative medicine advanced therapy' (RMAT) (). Qualifying criteria In order to qualify for RMAT status, a treatment must # meet the definition of a regenerative medicine therapy, # intend to treat, modify, reverse or cure a serious condition, and # b ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 U.S. state, states, a Washington, D.C., federal district, five major unincorporated territories, nine United States Minor Outlying Islands, Minor Outlying Islands, and 326 Indian reservations. The United States is also in Compact of Free Association, free association with three Oceania, Pacific Island Sovereign state, sovereign states: the Federated States of Micronesia, the Marshall Islands, and the Palau, Republic of Palau. It is the world's List of countries and dependencies by area, third-largest country by both land and total area. It shares land borders Canada–United States border, with Canada to its north and Mexico–United States border, with Mexico to its south and has maritime borders with the Bahamas, Cuba, Russia, and other nations. With a population of over 333 million, it is the List of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Advanced Therapy Medicinal Product
Advanced Therapy Medicinal Products, or ATMPs, are advanced therapeutic drugs that are based on cell therapy or gene therapy (sometimes in combination with a medical device - where they are then called a tissue engineered product). The criteria to which a drug must conform to be classified as an ATMP, are defined in Article 17 of Regulation (EC) No 1394/2007 by the European Commission The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body .... References Gene therapy Drugs {{drug-stub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been described as a ''sui generis'' political entity (without precedent or comparison) combining the characteristics of both a federation and a confederation. Containing 5.8per cent of the world population in 2020, the EU generated a nominal gross domestic product (GDP) of around trillion in 2021, constituting approximately 18per cent of global nominal GDP. Additionally, all EU states but Bulgaria have a very high Human Development Index according to the United Nations Development Programme. Its cornerstone, the Customs Union, paved the way to establishing an internal single market based on standardised legal framework and legislation that applies in all member states in those matters, and only those matters, where the states have agree ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ministry Of Health, Labour And Welfare
The is a cabinet level ministry of the Japanese government. It is commonly known as in Japan. The ministry provides services on health, labour and welfare. It was formed with the merger of the former Ministry of Health and Welfare or and the Ministry of Labour or . The Minister of Health, Labour and Welfare is a member of the Cabinet and is chosen by the Prime Minister, typically from among members of the Diet. Organization The ministry contains the following sections as of 2019: * The Minister's Secretariat (including the Statistics and Information Department) * The Health Policy Bureau * The Health Service Bureau * Pharmaceutical and Food Safety Bureau (including the Food Safety Department) * The Labour Standards Bureau (including the Industrial Safety and Health Department, Workers Compensation Department, and Workers' Life Department) * The Employment Security Bureau (including the Employment Measures for the Elderly and Persons with Disabilities Department) * The H ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceuticals Policy
Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs (both brand name and generic), biologics (products derived from living sources, as opposed to chemical compositions), vaccines and natural health products. Funding of research in the life sciences In many countries, an agency of the national government (in the U.S. the NIH, in the U.K. the MRC, and in India the DST) funds university researchers to study the causes of disease, which in some cases leads to the development of discoveries which can be transferred to pharmaceutical companies and biotechnology companies as a basis for drug development. By setting its budget, its research priorities and making decisions about which researchers to fund, there can be a significant impact on the rate of new drug development and on the disease areas in which new drugs are developed. For example, a major investment by the NIH into ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
