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At its meeting in Jacksonville, Florida, in early December, the newly-restructured ICH Assembly met in person for the first time, bringing together regulators and industry members, including observers from WHO, other regulators, and industry associations. In addition to reviewing a new application process for new members and observers, the Assembly also encouraged members of the former Global Cooperation Group to take the opportunity to automatically become observers before January 23, 2016, as allowed under the new membership process. The Southern African Development Community (SADC), the Gulf Cooperation Council (GCC), Brazil’s ANVISA, the Pan American Network for Drug Regulatory Harmonization (PANDRH), and the Asia-Pacific Economic Cooperation (APEC) were welcomed as the first observers under the new rules. In a press release, ICH also provided updates on the progress of several safety and efficacy guidelines. The next ICH meetings will be held June 11-16 in Europe, and November 5-10 in Japan.
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