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As of 2008, most states have enacted some sort of pedigree requirement and many have also required an epedigree. However, the existing epedigree requirements amount to little more than requiring that pharmaceutical supply chain companies be able to provide reports in formats such as pdf, text files or spreadsheets.
The US Drug Supply and Chain Security Act (DSCSA), was enacted by Congress on November 26, 2013 and outlines requirements to build electronic systems that identify and trace prescription drugs distributed in the US. [8] By November 27th 2023, full electronic track & trace capability will be required for all partners in the supply chain. [9]
Title II, the Drug Supply Chain Security Act (DSCSA), established requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. These requirements included a ten-year timeline culminating in the building of "an electronic, interoperable system to identify and trace certain ...
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 ...
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis
The pharmaceutical industry is a medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or self-administered by) patients for curing or preventing disease or to alleviate symptoms of illness or injury.
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
Shanghai Pharma is the largest pharmaceutical and the first A+H listed company in China to be dual-listed by Shanghai and Hong Kong Stock Exchanges. [ 2 ] [ 3 ] As of year 2020, the company made its presence to the Global Fortune 500 list with the ranking of 473, overall and 124 among 21 other Chinese companies on the list.