IPQ Inside the global regulatory dialogue

Pandemic Spurs Deepening of Pharmacopoeia/Regulator/Industry Communication Channels

Dec 23rd, 2020

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The pandemic is prompting all of those involved in medicine production, regulation, and standards-setting to take a hard look at their operations for how they can be: ● adapted to continue being productive and address the pandemic exigencies, as well as ● potentially improved on a longer-term basis. It is also significantly deepening communication and cooperation channels.

This multi-part story provides a wealth of insights from some of the key players involved in the adaptations and collaborative efforts that have been taking place in addressing the myriad of challenges involved. The story focuses, in particular, on the impact on the European and US Pharmacopeias (Ph. Eur/USP) and their relationship with regulators and industry as they work together to respond to the pandemic and other emerging health threats.

Part I: EDQM Pandemic Actions Continue Apace in Fall 2020

The first part of the story reviews the series of actions the European Directorate for the Quality of Medicines and Healthcare (EDQM) has taken during the Fall of 2020 in the context of the COVID pandemic to enhance its contribution to vaccine and therapy quality and supply management. The actions have been directed at fostering understanding of and access to EDQM/Ph. Eur. resources, and supporting product and analytical technologies and the drug supply chain. Among the latter is adjusting the procedures for the Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) to better fit the needs of stakeholders and the pandemic exigencies.

Part II: Panel of Pharmacopeia, Regulator and Industry Experts Explores Pandemic and Nitrosamine Communications

The need to collaborate on addressing the problems of the pandemic and nitrosamine contamination in the drug supply chain has strengthened the communication processes between pharmacopeias, regulators, and industry. The second part of the story reviews the dialogue on this communication impact that took place between a panel of leading experts from the three groups on the last day of a PDA pharmacopeia conference held in the Fall of 2020. Included in the dialogue was a review of the challenges and benefits of harmonization in the pandemic context.

Part III: Second Panel Focuses on Pandemic Organizational Impacts and Key Learnings

A second panel of leading pharmacopeia, regulator, and industry experts followed to explore more deeply the impact that the COVID pandemic has had on the way their organizations function and the most salient learnings that have been garnered.  The panelists all cited the more frequent exchanges that have been happening across the pharmacopeia/agency/industry spectrum to support collaboration – facilitated by the expanded digital meeting platforms. The lessons learned centered around the power of teamwork, communication, science/data sharing, and planning. Also reviewed in this part of the story are the first two days of the PDA pharmacopeia conference at which maintaining the supply chain and supporting COVID medicine development were in focus, respectively.

Part IV: EDQM and Ph. Eur. Evolution Addressed by Leaders Keitel and Vielle

Part four provides a broader update on EDQM and the European Pharmacopoeia it houses, including how they have been evolving and current priorities. In focus are insights from Ph. Eur.’s Cathie Vielle provided at the PDA Europe meeting in June into how the pharmacopoeia’s efforts complement those of regulatory agencies around the world and support the biopharmaceutical industry. She addressed Ph. Eur.’s: ● legal status, structure, and public health role ● engagement with the control of different types of impurities ● response to the COVID-19 pandemic, and ● current quality standard activities in the areas of biologicals, finished products, substances for pharmaceutical use, and general methods. Further insight on the role that EDQM and Ph. Eur. play in medicine quality was provided by EDQM’s Susanne Keitel in her keynote presentation at the June 2019 conference held in Strasbourg, France in conjunction with the release of the 10th edition of Ph. Eur, where she explored EDQM’s evolution, what it has achieved, and its goals.

[The story continues for subscribers on p. 2.  Nonsubscribers can get information on individual IPQ subscriptions and organization-wide licenses by contacting Peter Blachly ([email protected]).]

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