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The Central Drugs Standard Control Organisation ( CDSCO) is India 's national regulatory body for cosmetics, pharmaceuticals and medical devices. It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union. The Indian government has announced its plan to ...
The government earlier on 14 August 2019 appointed Dr. VG Somani as Drug Controller General of India (DCGI). Dr. VG Somani succeeded S Eswara Reddy, the interim DCGI who was appointed in February 2018. DCGI heads the Indian drug regulatory body the Central Drugs Standard Control Organisation (CDSCO), whose functions include ensuring the quality ...
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information ...
Pharmacovigilance ( PV, or PhV ), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. [1] : 7 The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to ...
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