DIA EUROPE 2021

On July 11th, 2017, FDA announced an initiative called “Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC)” in the US Federal Register. PQ/CMC is a structured data format that will enable consistency in the content and format of CMC data, providing a harmonized language for submission content, allowing reviewers to query the data, and, in general, contribute to a more efficient and effective regulatory decision-making process. According to the FDA, “The standardization of PQ/CMC data elements and terminologies will facilitate the Agency's transition to a streamlined electronic review environment.” The initiative was accepted as a topic by the ICH assembly in 2020 under the title “Structured Product Quality Submissions (SPQS)” and the work will be determined by the new ICH M4Q EWG. FDA is expected to publish guidance on their PQ/CMC effort in the US in 2021. With the implementation of PQ/CMC and acceptance SPQS as an ICH topic, what are opportunities and challenges of implementing standardized data to Module 3? How will this impact ISO IDMP implementation in Europe? The session will provide an opportunity to learn more about this area and also initiate the discussion between Industry and EU/US regulators as to how this can become a globally harmonized approach.