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In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Following is a list of antipsychotics, sorted by class. Antipsychotics. Antipsychotics by class Generic name Brand names Chemical class ATC code
Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements. [5] [6]
United States: Although ICH GCP guidelines are recommended by the Food and Drug Administration (FDA), [4] they are not statutory in the United States. The National Institutes of Health requires NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be ...
This is a list of psychiatric medications used by psychiatrists and other physicians to treat mental illness or distress. The list is ordered alphabetically according to the condition or conditions, then by the generic name of each medication. The list is not exhaustive and not all drugs are used regularly in all countries.
ICH E6 includes details of only a minimum list of contents and no other regulation or guideline provides a comprehensive list of TMF content. As a result of the inconsistencies that were developing across the sector, an industry group comprising 7 members from the GCP-RMA (Good Clinical Practice Records Managers Association) decided to develop ...
List of Antiviral Drugs Antiviral Use Manufacturer Component Type Year approved Abacavir: HIV: ViiV Healthcare: Nucleoside analogue reverse transcriptase inhibitor (NRTI) 1998 Acyclovir (Aciclovir) Herpes Simplex, chickenpox, [2] varicella zoster virus: GSK: guanosine analogue RTI 1981 Adefovir: Hepatitis B [3] Gilead Sciences RTI 2002 , 2003 ...