International regulators pledge collective support to combat COVID-19 pandemic
EMA has endorsed a joint COVID-19 statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) committing to a strengthening of global collaboration in the fight against coronavirus disease.
‘The COVID-19 pandemic affects the whole world and the best way to fight it is through globally concerted actions,’ said Guido Rasi, Chair of ICMRA and EMA’s Executive Director. ‘Our collaboration as regulators is crucial to increase the efficiency of regulatory processes and decision-making that will facilitate rapid development, approval and global roll-out of safe and efficacious medicines against COVID-19.’
In their joint statement regulatory authorities from around the world reiterate their call to action for governments and the international research community to prioritise large, well-designed, controlled clinical trials because they are most likely to generate the robust evidence for the safety and efficacy of proposed therapies for COVID-19 needed for decision-making by regulators. They emphasise their commitment to a global approach to achieve equitable access around the world to therapeutics and vaccines against COVID-19 and they also call on the pharmaceutical industry to step up their cooperation on therapeutics development and jointly address drug supply issues, shortages and decreased manufacturing capacities.
The development of a joint COVID-19 statement follows a series of meetings, organised by EMA under the umbrella of ICMRA in March and April, to discuss the global efforts to expedite and streamline the development and approval of COVID-19 vaccines and treatments.
For more details please see the original EMA communication.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
