CIRS has collected regulatory assessment data for over 20 years, initially with ICH and ICH-observing countries. The OpERA programme, “Optimising Efficiencies in Regulatory Agencies (OpERA)”, was initiated through CIRS in 2013 with agencies from Asia, Latin America, Africa and the Middle East. Since then, CIRS has expanded this programme to over 20 countries and several regional alignment initiatives. OpERA is a global programme, available to all regulatory agencies irrespective of their size, mission or maturity.

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