ICMRA, WHO take stock of regulatory flexibilities

Regulatory NewsRegulatory News | 06 December 2021 |  By 

A global regulatory group is mapping out a strategy for regulatory alignment as countries around the world plan their responses in the face of the Omicron variant of SARS-CoV-2, the virus that causes COVID-19.
The International Coalition of Medicines Regulatory Authorities (ICMRA) met on the first two days of December to discuss a host of regulatory challenges. Thirteen World Health Organization (WHO) and EC officials joined representatives from ICMRA’s 24 health authority members.
Emer Cooke is the executive director of the European Medicines Agency (EMA); she also currently chairs ICMRA. "The pandemic has increased the urgency for us to converge on responses both to existing regulatory challenges and complex new ones," she said in a press release following the meeting. "ICMRA has proven its value during the COVID-19 response, both as a platform for sharing information and best practices and as a venue for providing strategic leadership, active information sharing, pragmatic solutions and regulatory convergence."
In December 2020, ICMRA assembled a review of regulatory flexibilities implemented by global regulatory authorities who represented five WHO regions, reporting on a total of 52 guidance and other documents that implemented varying measures of flexibility across regulated health products.
That updated report, co-published by ICMRA and WHO, “features concrete examples of regulatory flexibilities and extraordinary measures that have been put in place in different areas of medicines regulation,” according to the EMA summary of last week’s meeting.
The information sharing about regulatory flexibility spans clinical trial oversight; all aspects of inspections and import/export activities; and also addresses medical devices, including personal protective equipment, in vitro diagnostics, and hand sanitizer. The report also details steps taken to address medicine shortages and ease access, and to ensure post-marketing activities such as pharmacovigilance efforts can continue during the strictures of the pandemic.
“As a next step, global regulators are encouraged to share their experiences and exchange information concerning the effectiveness of the regulatory flexibilities they have applied during the pandemic,” wrote EMA in its report of the recent ICMRA meeting. It is expected that this feedback will help to identify best practices for future public health crises and, where appropriate, even normal regulatory activities.”


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