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        FDA Data Standards Advisory Board

Pharmaceutical Quality - Chemistry, Manufacturing & Controls | PQ/CMC

                        
                PQ/CMC Data Standards Scope & Development
          PQ/CMC Federal Register Notices
          PQ/CMC and HL7 FHIR
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          Pharmaceutical Quality - Chemistry, Manufacturing & Controls | PQ/CMCFDA Data Standards Advisory Board Pharmaceutical Quality - Chemistry, Manufacturing & Controls | PQ/CMC
  	
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    Print**PQ/CMC at January 2023 HL7 Connectathon**: A section of the draft FHIR implementation guide for FDA’s PQ/CMC effort will be tested at the upcoming January 2024 HL7 FHIR Connectathon, January 16-18, 2024. The Connectathon Track page is now live and content will be updated as we get closer to the connectathon. January’s Connectathon is an all-virtual event. View information about the January Virtual Connectathon and registration. Individuals that have prior experience in the CMC domain, with computer-based documentation, authoring of CMC information, and/or an understanding of FHIR may find the PQ/CMC track of interest. Please note that testing of an IG at a connectathon is purely a *technical* test in anticipation of future balloting at HL7. Connectathon testing and balloting does *not* represent the IG in a final form nor does it represent in any way a statement of policy or guidance from FDA.


As part of an effort intended to support future electronic acquisition and use of submitted information, FDA has undertaken a project to identify and prioritize pharmaceutical quality/chemistry, manufacturing and controls (PQ/CMC) information that would benefit from a structured submission approach. This structured and standardized information is intended to be submitted in the Module 3 of the Common Technical Document as defined by the International Council for Harmonisation’s (ICH) M4 Common Technical Document (CTD). The effort is scoped to some of what is currently submitted in Module 3 and Module 2.3 of the electronic Common Technical Document (eCTD) submission. It is not intended to be comprehensive in structuring all eCTD product quality information, only those concepts that were considered amenable to structuring and would bring value to the quality review process.

The goal of this project is to establish electronic standards for submitting Pharmaceutical Quality (PQ) and Chemistry & Manufacturing Controls (CMC) data.

Specific objectives of the PQ/CMC Project are:

Develop structured data standards for PQ/CMC
	Develop a data exchange standard for submitting the structured PQ/CMC data to the FDAThe submission of structured data in a standardized format should increase the efficiency of FDA’s review of PQ/CMC data 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).

For consistency of product quality data across FDA centers, the draft standardized data elements and terminologies were created by an Agency workgroup comprised of Subject Matter Experts (SMEs) from the Center for Drug Evaluation and Research (CDER), the Center for Veterinary Medicine (CVM), and the Center for Biologics Evaluation and Research (CBER).

The PQ/CMC Data exchange standard is intended to be developed as Health Level 7 (HL7) Fast Health Interoperable Resources (FHIR) representation. The project has been established with the HL7 Biomedical Research & Regulation (BR&R) work group and discussions regarding representing the PQ/CMC structured elements in FHIR occur during the work group meetings. These HL7 BR&R WG meetings are open to the public.

PQ-CMC CTD Triangle Figure 1: ICH CTD Modules
Figure 1: ICH CTD Modules

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For additional information/support from PQ/CMC Team, please contact PQ-CMC@fda.hhs.gov.

                                                                                  Content current as of:
      12/19/2023
                  
                   
Regulated Product(s)
		 DrugsPharmaceutical Quality - Chemistry, Manufacturing & Controls | PQ/CMC                
                          

                        Data Standards Scope & Development
          Federal Register Notices
          PQ/CMC and HL7 FHIR
          PQ/CMC and IDMP
          Terminology
          Conceptual Model
 
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