> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Draft PQ/CMC Standardization Concerns Raised
- URL: https://www.fdaweb.com/draft-pq-cmc-standardization-concerns-raised/
- Published: 2017-09-13T12:00:00.000Z
- Updated: 2026-09-14T22:49:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139614

Several drug companies and their trade association are raising concerns about an FDA “Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminology” document. Sanofi [says](https://www.regulations.gov/document?D=FDA-2017-N-2166-0008&ref=fdaweb.com) it feels strongly that the effort will have a significant impact on underlying data systems within the industry as well as on the subsequent nature of reporting and analysis interactions between the agency and industry over the lifetime of a product. “It is therefore critical that FDA approach this effort through a highly collaborative and measured process including multiple opportunities for feedback and testing by manufacturers and system vendors during all phases including the definition/design and implementation,” the company asserts.

Genentech [says](https://www.regulations.gov/document?D=FDA-2017-N-2166-0005&ref=fdaweb.com) it supports the move to submit pharmaceutical quality/chemistry, manufacturing, and control (PC/CMC) data in a standardized electronic format to increase drug review efficiency and quality. It says it believes the selected CMC data elements are suitable and appropriate, and it urges FDA to ensure that in the implementation guide nomenclature is consistent and abbreviations are defined.

The Johnson & Johnson comment [letter](https://www.regulations.gov/document?D=FDA-2017-N-2166-0009&ref=fdaweb.com) says that the agency draft needs further work “in enriching the descriptions of the data elements and clarifying their applicability in line with the information typically found in Module 3, resolving ambiguity existing between controlled values within a category, and introducing minimum structure to some data elements, which currently remain uncontrolled.”

Boehringer Ingelheim [says](https://www.regulations.gov/document?D=FDA-2017-N-2166-0013&ref=fdaweb.com) that given the FDA stated objective of a standardized format, there are alternative approaches to achieve this goal through the currently accepted PDF file format that would avoid industry disruption in retooling to create CMC documents in XML format. One alternative, it says, could be a mandatory template on the agency Web site. The company also notes the lack of an implementation timeframe and proposes a staged approach starting with a pilot program for one Module 3 document type in the XML format using the data elements and terminologies described in the initiative.

Pharmaceutical Research and Manufacturers of America (PhRMA) [expresses](https://www.regulations.gov/document?D=FDA-2017-N-2166-0014&ref=fdaweb.com) concern with the lack of context in the FDA draft explaining how the PQ/CMC initiative fits into the agency’s overall strategic planning around structured product information. “Without this context,” it says, “the release of this standalone draft standardization document does not provide the level of detail needed for stakeholders to understand, anticipate, and comply with future requirements to submit structured data elements and terminologies in a submission. PhRMA strongly urges FDA to consider the impact on sponsors, particularly as changes, even minor, in a standard may require the company’s initiation of an impact assessment, development or purchase of new software (including validation of new systems and software), development of new processes, updates to data capture systems, additional training of personnel, rework of components of submissions that had already been prepared, or all of the above.”

Merck [says](https://www.regulations.gov/document?D=FDA-2017-N-2166-0010&ref=fdaweb.com) it supports the FDA stated intent to align PQ/CMC data elements with those in the European Medicines Agency’s ISO IDMP standards where available. “However, it appears the PQ/CMC initiative is being developed independently by FDA, which may result in a product that is not globally harmonized,” it says. “We encourage FDA to collaborate broadly with global industry, standards bodies, and health authorities to align first on the above intent and strategic fit of the PQ/CMC initiative and intended primary uses of the data elements.”

Finally, Novartis provided line-by-line specific [comments](https://www.regulations.gov/document?D=FDA-2017-N-2166-0007&ref=fdaweb.com).