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The UCPMP is an extension of the Uniform Code for Pharmaceuticals Marketing Practices 2015 (UCPMP 2015), which took effect on 1 January 2015.Although there were long-standing expectations that the 2015 Code would be legally enforced, it remained a voluntary guideline for pharmaceutical companies to follow in their marketing practices.
World Health Organization building from the South-East, Geneva The International Pharmacopoeia (Pharmacopoeia Internationalis, Ph. Int.) is a pharmacopoeia issued by the World Health Organization [1] as a recommendation, with the aim to provide international quality specifications for pharmaceutical substances (active ingredients and excipients) and dosage forms, [2] together with supporting ...
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 ...
The WHO Smart Guidelines are part of a broader global trend of digitizing clinical guidelines to make them more actionable in healthcare systems. For example, the Centers for Disease Control and Prevention (CDC) in the United States developed the "Adapting Clinical Guidelines for the Digital Age" (ACG) initiative, which promotes a holistic ...
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.
ATC follows guidelines [17] in creating new codes for newly approved drugs. An application is submitted to WHO for ATC classification and DDD assignment. A preliminary or temporary code is assigned and published on the website and in the WHO Drug Information for comment or objection. New ATC/DDD codes are discussed at the semi-annual Working ...
GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates.
This list contains 1200 recommendations for 591 drugs and 103 therapeutic equivalents. [20] A separate list for children up to 12 years of age, known as the WHO Model List of Essential Medicines for Children (EMLc), was created in 2007 and is in its 9th edition.