Regulators tout ICMRA pilots, adoption of ICH guidelines as major steps toward convergence

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. (RELATED: ICMRA explores hybrid inspections, postapproval changes with new pilots, Regulatory Focus 29 June 2022)

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. (RELATED: FDA announces completion of first joint assessment with EMA in ICMRA pilot, Regulatory Focus 28 July 2023)

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 a 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.

Other PMDA milestones

Kishioka noted that this year PMDA will celebrate its 20^th anniversary. Another noteworthy development is that PMDA is expanding its global reach by establishing a global an office in Bangkok, Thailand this year.

Plans are also in the works to establish an office in Washington, DC, but a date has not yet been set. “We don’t know when we will open this office, but the aim is to expedite the information exchange with the FDA and to stimulate conversation.”

WHO guidelines

Azatyan from WHO provided an update on regulatory collaboration efforts and noted that such collaborations are essential to the organization. He said that “strong regulatory capacity is an essential component of a well-functioning health systems.” Yet while such strong systems are needed and “an essential component of any well-functioning health system, unfortunately the reality is not very bright. Today globally more than 70% of our member states have weak national regulatory systems.”

WHO is trying to address these challenges by building up weaker regulatory systems through benchmarking activities and identifying gaps where regulatory capacity is needed.

To promote collaboration, the group in March 2021 released a guidance document on good regulatory practices which is a set of principles and practices that can be applied to the development and implementation of regulatory instrument to achieve its public health goals.

In October 2022, WHO released a Short eLearning course of main principles and examples of reliance, which is now available in several languages, including Spanish, English, and French. Azatyan also noted that this module is meant to complement its annex on the subject.

WHO is also organizing its biennial International Conference of Drug Regulatory Authorities (ICDRA) which is usually held biennially but has been postponed due to COVID. The meeting will be held in New Delhi India in October.

Azatyan noted in his concluding remarks that “we have to join our forces to build harmonized regulatory harmonization that promotes global health. Alone, none of us can achieve anything substantial.”

Regulators tout ICMRA pilots, adoption of ICH guidelines as major steps toward convergence

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