Regulators from around the globe touted some of the progress made to increase their collaborations through the joint review pilots sponsored by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the adoption of the International Council for Harmonisation’s (ICH) guidelines on viral safety evaluation and analytical method development as major accomplishments in 2023.
These collaborative and harmonization efforts were described by three regulators during a session on global convergence at the CASSS Well-Characterized Biotechnology Products (WCBP) conference in Washington, DC on Tuesday. They also discussed milestones within their respective agencies.
Speakers included Samvel Azatyan, team lead for regulatory convergence and networks at the World Health Organization (WHO), Yasuhiro Kishioka, review director in the Office of Cellular and Tissue-based Products at Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), Steve Kozlowski, director of the Office of Biotechnology Products within the Office of Pharmaceutical Quality at the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, and Nino Mihokovic, a quality specialist at the European Medicines Agency (EMA).
Mihokovic noted during his presentation that much progress has been made by regulators to collaborate with each other on reviews. He said when he first joined EMA, getting assessment reports from FDA was a long and laborious process. First EMA officials had to go through the bilateral liaison office and request these documents, then go through a series of formal steps to set up a communication pathway with FDA.
He noted that with the ICMRA pilot, many of these barriers have been removed. “We have an open assessment pilot which includes the participants from other countries where they could ask questions and participate in the assessment but yet maintain degree of independence with their own decision making.”
In 2022, ICMRA announced it was seeking industry participants for two pilot programs, one exploring a common regulatory framework for assessing manufacturing facilities in hybrid inspections and the other for reviewing post approval changes.
In July 2023 FDA announced the completion of its first collaborative assessment of a post-approval change for an oncology medicine with the European Medicines Agency (EMA) under the joint review pilot program.
Kozlowski said that under the ICMRA pilots “there were a number of collaborative assessments of change management protocols which were successful, and I think that was a great achievement.”
He added that this year there will be an ICMRA workshop on pharmaceutical quality management, which he called a “very important topic to get global connections and convergence on.”
Kishioka echoed Kozlowski and asserted that “from a PMDA point of view, IMCRA was a big achievement last year.”
Kozlowski further noted that “there were a lot of accomplishments” in the ICH space with the sign-off and adoption of three documents, including ICH Q5A (R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, ICH Q2(R2) on validating analytical procedure, and ICH Q14 on analytical procedure development were major steps forward.
To continue reading this article please go to RAPS .