Description
This guidance is intended to assist applicants who submit content of labeling to FDA as part of a marketing application using the structured product labeling standard (SPL) in extensible markup language (XML). The guidance also provides information to FDA staff who review and manage product information using electronic systems. This is revision 1 of a guidance of the same name that was issued in December 2005. The guidance has been revised to reflect changes in the technology since 2005 and to harmonize the submission of SPL in the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). We anticipate that additional guidance will be provided as new questions arise about the use of SPL in different contexts.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1The drug referenced by an ANDA.
Stakeholders
1If an applicant notes an inconsistency, he or she should contact the SPL coordinator
Regulatory Context
Regulatory Activities
7FDA will transmit postapproval SPL to the Web from the electronic drug establishment registration system
Alternative transmission method for SPL-formatted submissions
Changes Being Effected supplement
Changes Being Effected supplements for labeling updates; Changes Being Effected supplement labeling
Biologics License Application
Abbreviated New Drug Application
New Drug Application
Document Types
10Required patient labeling
PPIs should be included at the end of the SPL file
SPL content of labeling does not replace the 12 copies of paper labeling known as FPL
Stability data must be provided in annual reports
recommend that applicants continue to submit the annotated Word version of the label
Labeling document not required to be in SPL standard
Focus of the safety considerations and design principles; Primary labeling on the immediate container
Labeling document not required to be in SPL standard
Portable Document Format used for submissions; primary file format used for an eCopy; Standard format for eCopy submissions.
The specific labeling information required to be submitted in SPL format; labeling in a foreign language
Attributes
1characteristic of the content of labeling
Standards & References
External Standards
3Logical Observation Identifiers Names and Codes for laboratory tests; Controlled terminology for laboratory tests
Extensible markup language file format
Structured Product Labeling HL7 standard
Related CFR Sections (4)
- 21CFR601.14§ 601.14 Regulatory submissions in electronic format.
(a) General. Electronic format submissions must be in a form that FDA can process, review, and archive. FDA will periodically issue guidance on how to provide the electronic submission (e.g., method of transmission, media, file formats, preparation and organization of files.)Read full regulation →
- 21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (5)
- Providing Regulatory Submissions in Electronic Format — Content of Labeling (Status: Final)
- Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (Status: Final)
- Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Status: Final)
- CPG Sec 120.500 Health Fraud - Factors in Considering Regulatory Action (Status: Final)