ICMRA: Industry commitment to quality can facilitate regulatory flexibility

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Posted on October 12, 2021 | Through Joanne S. Eglovich

Frequent communications with industry and the use of evaluations from other regulators have enabled the rapid scale-up of COVID-19 vaccines and therapies, said regulators and industry representatives attending a workshop in July sponsored by the International Coalition of Drug Regulatory Authorities (ICMRA).

The workshop explored how different regulatory tools are being deployed to increase vaccine manufacturing capacity during the COVID-19 pandemic. The workshop had the dual purpose of helping regulators understand the manufacturing challenges faced by the industry during the pandemic, while sensitizing the industry to the variety of regulatory pathways and flexibilities that have enabled vaccine manufacturing. and therapeutic products to develop so rapidly.

The virtual workshop included representatives from more than 30 drug regulatory authorities around the world, and 330 participants listened online. The workshop transcript was published recently.

The experience gained from the workshop “highlighted the most important catalysts for the industry to maximize the use of regulatory flexibilities introduced in response to the COVID-19 pandemic to support manufacturing and post changes. -approval, “according to an ICMRA statement released on Tuesday.

Building on the survey results and other data presented at the workshop, the ICMRA statement highlighted how the industry achieved ‘key enablers’ that enabled regulatory agility without precedent observed over the past 18 months. For its part, the industry called for greater regulatory harmonization in the form of a global dossier that achieves a common standard for submissions.

The industry, ICMRA wrote, had “open and ongoing” communication with regulators on topics ranging from submissions to supply chain issues. Being on a solid footing with process and manufacturing issues was also essential, as was good manufacturing practice (GMP) compliance for manufacturing sites and, most importantly, the establishment of pharmaceutical grade systems (PQS). efficient in facilities.

“The combination of product and process understanding with an effective PQS, combined with open and continuous communication between stakeholders, allows regulators to use greater regulatory flexibility when approving manufacturing changes,” wrote ICMRA.

A survey presented at the workshop showed how 11 regulatory agencies are leveraging different regulatory tools to enable rapid scale-up of vaccines. Among the regulatory bodies included in the investigation were the United States Food and Drug Administration (FDA), the EU’s European Medicines Agency (EMA), the Japan Pharmaceutical and Medical Devices Agency (PMDA) , the Therapeutic Goods Administration (TGA) of Australia and the Medicines and Medical Devices of the United Kingdom. Health Products Regulatory Agency (MHRA).

During the workshop, Greg Perry of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said the pandemic has sparked “unprecedented partnerships” between regulators and industry since the approval of the first COVID-vaccine. 19. These partnerships have made it possible to accelerate the approval of these vaccines, resulting in an increase of “from 0 to 3 billion [doses] in just six months since the approval of the first vaccine.

Survey results

Presenting the results of the survey to regulators, Seán Barry of the Irish Health Products Regulatory Authority noted that all regulators said they have established “rapid, frequent and ongoing engagement” with manufacturers to approve these vaccines. . In addition, he said, all have provided guidelines to clarify regulatory expectations on how these assessments will be prioritized. In addition, all approved post-approval changes in the absence of complete data, with the stipulation that some data will be provided at a later date.

All regulators also reported that they use a document review of submissions, and all respondents also review inspection reports from other agencies through a mutual recognition agreement (MRA) or confidentiality agreements.

The survey also showed that 91% of regulators used continuous submissions to approve vaccines, with the same number having used comparability protocols, Barry said.

However, regulators have not fully explored the use of assessment reports from other agencies or joint assessment to approve vaccines. The survey showed that 64% of regulators rely on assessment reports from regulators in other regions to approve vaccines, while 73% participate in joint assessments.

More joint evaluations

Industry members said the use of a global folder should be encouraged when asked to tell lesson “number one” from the COVID pandemic.

Graham Cook, senior director of global sourcing – quality operations for Pfizer, said a global dossier as well as an “agreed common standard for pandemic regulatory submissions” would improve manufacturing capacity. He added that “frequent and effective communication between companies and agencies” is essential to enable enhanced capacity.

Cook said the company had engaged in “weekly and sometimes daily” meetings with regulators to seek approval for the Comirnaty mRNA vaccine that Pfizer jointly developed with BioNTech. Still, he admitted that such a frequent level of communication is “probably not sustainable” in the long run without a comprehensive case.

Connie Langer, regulatory strategist at Pfizer, agreed with Cook. She said that such a comprehensive package “would go a long way in reducing the time for the initial submission and review of these packages and improving manufacturing capacity.”

ICMRA workshop

ICMRA statement

© 2021 Society of Regulatory Affairs Professionals.



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