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With stability testing, pharmaceutical industry inspects the quality of drug substances and drug products as per the guidelines outlined by US Food and Drug Administration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to make sure that they retained the quality over the period of time.
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.
Nonclinical study reports. Clinical study reports; A full table of contents could be quite large. There are two categories of modules: Regional module: 1 (different for each region; i.e., country) Common modules: 2–5 (common to all the regions) The CTD defines the content only of the common modules.
On 24 February 1976, the treaty was signed into force by the leaders of the original members of ASEAN. [1] Other members acceded to it upon or before joining the bloc. It was amended on 15 December 1987 by a protocol to open the document for accession by states outside Southeast Asia, [2] and again on 25 July 1998, to condition such accession on the consent of all member states. [3]
The minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
The Economic Research Institute for ASEAN and East Asia or ERIA is an international organization established in Jakarta, Indonesia in 2008 by a formal agreement among Leaders of 16 countries in the East Asian region to conduct research activities and make policy recommendations for further economic integration in the East Asia. [1]
The treaty includes a protocol under which the five nuclear-weapon states recognized by the Treaty on the Non-Proliferation of Nuclear Weapons (NPT), namely China, the United States, France, Russia and the United Kingdom (who are also the five permanent members of the United Nations Security Council) undertake to respect the Treaty and do not ...