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A provisional registration shall be valid for 1 year and must be renewed. An establishment may apply for a permanent registration. The registration certificate must be prominently displayed. The Chapter V details the creation of state and national level Register of Medical Establishment in digital form. [3]
The Charter draws upon different provisions relevant to patients' rights that were previously scattered across the Constitution of India, the Drugs and Cosmetic Act of 1940, the Clinical Establishment Act of 2010, and various judgments by the Supreme Court of India, among other sources. [4] The Charter aims to:
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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 Register of Clinical Technologists (RCT) is a voluntary professional register for clinical technologists and practitioners specialising in the practical application of physics, engineering and technology to clinical practice in the UK. Registrants work in NHS hospitals, private health care, academic institutions and the medical device industry.
The International Clinical Trials Registry Platform (ICTRP) is a platform for the registration of clinical trials operated by the World Health Organization. [1]The ICTRP combines data from multiple cooperating clinical trials registries to generate a global view of clinical trials worldwide, with a search portal that allows access to the entire dataset.
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.