MHRA is helping create a self-appointed global regulatory body
...and it's rather concerning...
Begin with an internet search
The opening text reads:
A link to the newly published ICMRA paper, which provides a valuable insight into how global regulators have managed regulatory oversight, inspections and assessments during the pandemic to support both the COVID-19 response, and also ‘business as usual’ GMP and GCP inspections.
What in heaven’s name is the International Coalition of Medicines Regulatory Authorities (ICMRA)?
It describes itself as so:
International Coalition of Medicines Regulatory Authorities (ICMRA) is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities that work together to
address current and emerging human medicine regulatory and safety challenges globally, strategically and in an on- going, transparent, authoritative and institutional manner
provide direction for areas and activities common to many regulatory authorities' missions
identify areas for potential synergies
wherever possible, leverage existing initiatives/enablers and resources
ICMRA will provide a global architecture to support enhanced communication, information sharing, crisis response and address regulatory science issues.
The membership is impressive, to say the least. No self-respecting Regulatory Authority is missing from the list.
The Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) is Ms Emer Cooke.
Emer Cooke began her mandate as ICMRA Chair on 16 November 2020.
She has over 30 years of experience in international regulatory affairs, with more than 18 of these in leadership roles. Before taking up her current role, she was the Director responsible for all medical product-related regulatory activities at the World Health Organization (WHO) in Geneva between November 2016 and November 2020.
Ms Cooke worked at EMA between 2002 and 2016, holding various positions including Head of Inspections and Head of International Affairs. Prior to that, she was Principal Administrator in the Pharmaceuticals Unit of the European Commission between 1998 and 2002, with responsibility for inspections, international activities and legislative initiatives.
Previous ICMRA Chairs
Guido Rasi, Executive Director of the European Medicines Agency (EMA) (2019 - 2020)
Dr Ian Hudson, Chief Executive of the UK Medicines and Healthcare Products Regulatory Authority (MHRA) (2016 - 2019) [from 2019 onwards, Senior Advisor, Integrated Development, Bill & Melinda Gates Foundation]
Returning to the Blog and reflection paper
The Blog continues:
In August 2020, under the Chairmanship of Paula Walker, MHRA GCP Inspectorate Operations Manager and a Senior GCP inspector, the International Coalition of Medicines Regulatory Authorities (ICMRA) established a working group to look at the move to remote inspections for GCP and GMP during the pandemic.
On behalf of MHRA, Walker comments:
I was fortunate to chair this group of highly experienced regulators, reporting in to the ICMRA COVID-19 working group.
The working group…included representatives from US-FDA, EMA, Health Canada, Swiss-medic, HPRA Ireland, AEMPS Spain, ANSM France, PEI Germany, MHLW/PMDA Japan, TGA Australia, ANVISA Brazil, HSA Singapore, WHO, Saudi-FDA.
After an initial deep dive presented to the ICMRA Policy group in October 2020 on initial experiences of the changes to regulatory oversight to remote ways of working driven by the pandemic, the group moved forward to start work on a reflection paper on GCP and GMP remote inspections during the pandemic.
Walker comments further:
I am pleased to say that the ICMRA paper has now been published here . The paper is a collective reflection on the type of remote approaches taken by the different regulators across the globe.
Details of the paper can be found in the link above. For the time-poor among us, this is a conclusion taken from the opening section:
While the ICMRA group have found remote inspections an enabling tool to maintain at least a minimal regulatory oversight during the pandemic, it is not the view of the group that remote inspections would fully replace an on-site inspection programme. Notable limitations, with current available technological means, have been identified during the experience with the use of remote assessment of regulatory compliance and are described in the relevant subsections.
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