FDA Issues Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies, Requests Comments
July 19, 2017
On Tuesday, July 11th, FDA released its draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies for the electronic submission of this data.
What is PQ/CMC?
According to FDA’s announcement in the Federal Register, “PQ/CMC is a term used to describe manufacturing and testing data of pharmaceutical products.” This encompasses a number of important aspects in drug development, including drug stability, quality specification, and batch analysis. FDA notes that “PQ/CMC plays an integral part in the regulatory review process and life cycle management of pharmaceutical products.”
FDA Standardizes Data Elements & Terminology
FDA is identifying and standardizing the data elements and terminology for PQ/CMC data that is submitted electronically, and is commonly used to support drug product applications. FDA states that “the establishment of standardized pharmaceutical quality data elements and terminologies will provide opportunities for FDA and industry to transform PQ/CMC submission data into a readily useable electronic format.”
The reason for the Agency’s standardization of this information are the provisions from the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), which give the FDA the authority to require that certain submissions be made electronically. As such, developing a structured format for the submission of PQ/CMC data will ensure consistency among the content and format of the data being submitted, “thus providing a harmonized language for submission content, allowing reviewers to query the data, and, in general, contributing to a more efficient and effective regulatory decision-making process by creating a standardized data dictionary.”
FDA is asking interested parties to submit comments on the draft of this standardized data. The comments that the Agency receives will be used when considering future actions on the standardization of PQ/CMC data elements and terminologies for electronic submissions. Comments can be submitted electronically or in written format, and must be made by September 8, 2017.
ProPharma Group has a 35-year track record of helping our clients achieve successful interactions with the FDA and we have the experience you need to do exactly that. Contact us today to learn more about our services and how we can help you develop and submit a successful application.
Pre-RFD Process: FDA Introduces New Process to Classify Combination Products
During product development some sponsors struggle to determine how their product will be regulated by the FDA. Will it be considered a drug, medical device, biologic, or combination product? Based on...