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ICMRA: Industry's commitment to quality can facilitate regulatory flexibility

Posted 12 October 2021 | By Joanne S. Eglovitch 

ICMRA: Industry's commitment to quality can facilitate regulatory flexibility

Frequent communication with industry and relying on assessments by other regulators have enabled the rapid scale-up of COVID-19 vaccines and therapeutics, asserted regulators and industry representatives attending a July workshop sponsored by the International Coalition of Medicines Regulatory Authorities (ICMRA).
 
The workshop explored how different regulatory tools are being deployed to increase manufacturing capacity for vaccines during the COVID-19 pandemic. The workshop had dual goals of helping regulators understand the manufacturing challenges faced by industry during the pandemic, while at the same time boosting industry’s awareness of the variety of regulatory pathways and flexibilities that allowed vaccine and therapeutics manufacturing to scale so rapidly.
 
The virtual workshop included representatives from over 30 medicines regulatory authorities globally, and 330 participants listened online. The transcript of the workshop was recently made available.
 
The experience gleaned from the workshop “highlighted the most important enablers for industry to maximise the use of regulatory flexibilities introduced in response to the COVID-19 pandemic for supporting manufacturing and post-approval changes,” according to an ICMRA statement released Tuesday.
 
Drawing on survey results and other data presented at the workshop, the ICMRA statement highlighted how industry achieved “key enablers” that allowed the unprecedented regulatory agility seen in the past 18 months. For its part, industry called for more regulatory harmonization in the form of a global dossier that achieves a common standard for submissions.
 
Industry, wrote ICMRA, had “open and continuous” communication with regulators about topics ranging from submissions to supply chain issues. Being on firm footing with process and manufacturing issues was also key, as was achieving good manufacturing practice (GMP) compliance for manufacturing sites and, critically, establishing effective pharmaceutical quality systems (PQS) at facilities.

“The combination of product and process understanding with an effective PQS, combined with open, and continuous communication between stakeholders, allows regulators to utilise greater regulatory flexibility when approving manufacturing changes,” wrote ICMRA.
 
A survey presented at the workshop demonstrated how 11 regulators are leveraging different regulatory tools to enable the rapid scale-up of vaccines. Among the regulators included in the survey were the US Food and Drug Administration (FDA), the EU’s European Medicines Agency (EMA), Japan’s Pharmaceutical and Medical Devices Agency (PMDA), Australia’s Therapeutic Goods Administration (TGA), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
 
During the workshop, Greg Perry of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) said the pandemic has prompted “unprecedented partnerships” between regulators and industry since the first COVID-19 vaccine was approved. These partnerships have helped to expedite the approval of these vaccines, translating into an increase of “from 0 to 3 billion [doses] in just six months since the first vaccine approval.
 
Survey results
 
Presenting results of the survey of regulators, Seán Barry of Ireland’s Health Products Regulatory Authority noted that all regulators reported establishing “quick, frequent and continuous engagement” with manufacturers in approving these vaccines. Further, he said, all have provided guidelines to clarify regulatory expectations on how these assessments will be prioritized. In addition, all have approved post-approval changes in the absence of full data, with the stipulation that certain data will be provided at a later date.
 
All regulators also reported the regulators have been using desk-based review of submissions, and all respondents also review inspection reports by other agencies via a mutual recognition agreement (MRA) or confidentiality agreements.
 
The survey also showed that 91% of regulators have used rolling submissions to approve vaccines, with the same number having used comparability protocols, said Barry.
 
However, regulators have not fully explored relying on assessment reports from other agencies or joint assessment in approving vaccines. The survey showed that 64% of the regulators rely on assessment reports from regulators in other regions in approving vaccines, while 73% are participating in joint assessments.
 
More joint assessments
 
Industry members said that the use of a global dossier should be encouraged when asked to recount the “number one” lesson from the COVID pandemic.
 
Graham Cook, senior director of global supply – quality operations for Pfizer, said that a global dossier as well as an “agreed common standard for regulatory submissions in the pandemic” would enhance manufacturing capacity. He added that “frequent, effective communication between companies and agencies” is critical to enabling enhanced capacity.
 
Cook elaborated that the company engaged in “weekly and sometimes daily meetings” with regulators to obtain approval for the mRNA vaccine Comirnaty that Pfizer developed jointly with BioNTech. Yet he admitted that such a frequent level of communications is “probably not sustainable” in the long term without a global dossier.
 
Connie Langer, a regulatory strategist at Pfizer, concurred with Cook. She said that such a global dossier “would go a long way to decreasing the timelines for the initial submission and the review for these packages and to enhance the manufacturing capacity.”
 
ICMRA workshop
 
ICMRA statement

 

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