Marketing Authorization

	Marketing Authorization Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold. This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked. The application dossier for marketing authorisation is called a New Drug Application (NDA) in the USA or Marketing Authorisation Application (MAA) in the European Union and other countries, or simply registration dossier. This contains data proving that the drug has quality, efficacy and safety properties suitable for the intended use, additional administrative documents, samples of finished product or related substances and reagents necessary ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
	Marketing Authorization Application Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market. MAA is part of the official procedure before the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the Committee for Medicinal Products for Human Use of the European Medicines Agency, a specialised agency of the European Commission. In the 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 states, a federal district, five major unincorporated territori ..., the equivalent process is called New Drug Application. References {{reflist Drug safety ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
picture info	Common Technical Document The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States and beyond. Synopsis The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (FDA, US) and the Ministry of Health, Labour and Welfare (Japan) starting at the World Health Organization International Conference of Drug Regulatory Authorities (ICDRA) at Paris in 1989. The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada and Switzerland. The Paper CTD is des ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
	Electronic Common Technical Document 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]
	Radionuclide Generator A radionuclide generator is a device which provides a local supply of a short-lived radioactive substance from the decay of a longer-lived parent radionuclide. They are commonly used in nuclear medicine to supply a radiopharmacy. The generator provides a way to separate the desired product from the parent, typically in a process that can be repeated several times over the life of the parent. Use of a generator avoids the challenge of distributing short-lived radionuclides from the original production site (typically a nuclear reactor) to individual users; the loss of activity due to decay in transit can result in too little being supplied or the need for much larger initial quantities to be sent out (incurring additional production and transport costs). An alternative to generators for on-site production of radionuclides is a cyclotron, though it is uncommon that the same radionuclide can be provided by both methods. It is feasible to have cyclotrons at larger centres, but they are ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
picture info	Pharmaceutical Industry The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s, and from discoveries resulting from applied research. Intentional drug ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]