The RAPS website recently experienced issues that we continue to monitor.  Certain areas of the site including news may be limited.  We apologize for any inconvenience.

Regulatory Focus™ > News Articles > FDA Looks to Standardize PQ/CMC Data and Terminologies

FDA Looks to Standardize PQ/CMC Data and Terminologies

Posted 10 July 2017 | By Zachary Brennan 

The US Food and Drug Administration (FDA) on Monday said it is drafting and seeking comment on the use of standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements for electronic submission.

FDA, which is considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling (SPL) document, said the move to standardize PQ/CMC data elements and terminologies will improve the efficiency and quality of the drug review process. The shift is part of work done under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).

In terms of comment, FDA wants to hear from industry on the accuracy, suitability and appropriateness of these data elements and terminologies for submission of PQ/CMC data. According to an update from Ron Fitzman, senior advisor in FDA’s Office of Strategic Programs, the agency has been requiring certain standardized electronic submissions since 2004.


"The development of a structured format for PQ/CMC data will enable consistency in the content and format of PQ/CMC data 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 said.

The proposed data elements and terminologies can be obtained on Tuesday at: in Docket No. FDA- 2017-N-2166.

Federal Register

Regulatory Focus newsletters

All the biggest regulatory news and happenings.