HL7 FHIR® Implementation Guide: Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) Submissions to FDA, Edition 2- US Realm

DESCRIPTION

A US realm FHIR Implementation Guide for standardized exchange of structured pharmaceutical quality data between biopharmaceutical companies and the US Food & Drug Administration (FDA).

 

See the specification at http://hl7.org/fhir/us/pq-cmc-fda/STU2

ALTERNATIVE NAMES

HL7 FHIR® Implementation Guide: Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) Submissions to FDA, Edition 2- US Realm may also go by the following names or acronyms:

BENEFITS

• Improves the efficiency of FDA’s review of PQ/CMC data by the submission of structured data in a standardized format should contained in the Module 3 of eCTD submissions for:
  • a New Drug Application (NDA),
  • an Investigational New Drug Application (IND),
  • a Biologics License Application (BLA),
  • an Abbreviated New Drug Application (ANDA),
  • a New Animal Drug Application (NADA),
  • an Abbreviated New Animal Drug Application (ANADA),
  • an Investigational New Animal Drug (INAD), Generic Investigational New Animal Drugs (JINADs),
  • and a Master File (MF).

IMPLEMENTATIONS/CASE STUDIES

• Software vendors

DEVELOPMENT BACKGROUND

To support the US Food and Drug Administration (FDA) regulatory needs in receiving structured and standardized data in pharmaceutical quality as described in the FDA Strategic Priorities 2014-2018. The FDA intends to identify and standardize data elements and terminologies for information commonly used and submitted in support of the Agency’s review of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls (PQ/CMC) section of drug product applications.

RELATED DOCUMENTS

HL7 FHIR® Implementation Guide: Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) Submissions to FDA, Edition 2- US Realm

STU DOCUMENTS

	HL7 FHIR® Implementation Guide: Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) Submissions to FDA, Edition 2- US Realm See the standard at http://hl7.org/fhir/us/pq-cmc-fda/STU2.	(Submit Feedback on STU)
	HL7 FHIR® Implementation Guide: Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) Submissions to FDA, Edition 1- US Realm See the standard at http://hl7.org/fhir/us/pq-cmc-fda/STU1.	(Submit Feedback on STU)

TOPIC

• Regulated Products

BALLOT TYPE

• STU

STATUS DATE

2025-07-07

RESPONSIBLE WORK GROUP

PRODUCT TYPE

• Implementation Guide

STAKEHOLDERS

• Pharmaceutical Vendors
• Regulatory Agency

FAMILY

• FHIR

CURRENT STATE

• Active

REALM

• US Realm