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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.
Many guidelines and governance bodies have been established to ensure a common approach within a given industry to a set of parameters used to identify the minimally acceptable standard for that industry. The pharmaceutical industry is no exception, with several trade groups (e.g. PhRMA, EFPIA, RQA, etc.) coming together to enhance collaboration.
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 ...
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 ...
The standards allow for easier 'interoperability' of healthcare data as it is shared and processed uniformly and consistently by the different systems. This allows clinical and non-clinical data to be shared more easily, theoretically improving patient care and health system performance. [1]
The European Committee on Cosmetics and Consumer Health (CD-P-COS) [34] is tasked with responding to emerging risks for health arising from the use of cosmetics. By promoting the principles laid down in Council of Europe Resolution ResAP(2008)1 on requirements and criteria for the safety of tattoos and permanent make-up, [ 35 ] the committee ...
Improving the efficiency and effectiveness of evidence-based guideline development, adaptation, dissemination and implementation; Building a Network and partnerships for guideline developing organisations, end users (such as health care providers, healthcare policy makers and consumers) and stakeholders.
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 ...