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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.
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 ...
The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products.
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.
This publication laid the groundwork for CIOMS' 1982, 1993, 2002, 2009, and 2016 versions of International Ethical Guidelines for Health-Related Research Involving Humans. [3] These guidelines have been praised for including diverse stakeholders from low- and middle-income countries, compared to the Declaration of Helsinki written by physicians ...
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In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
Plates vi & vii of the Edwin Smith Papyrus (around the 17th century BC), among the earliest medical guidelines. A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare.