Submitting Marketing Applications According to the ICH/CTD Format: General Considerations

Description

This is one in a series of guidance documents that provide recommendations for applicants preparing a Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) for submission to the U.S. Food and Drug Administration (FDA). This guidance document is intended to describe how to organize new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biological license applications (BLAs) based on the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on the CTD. This guidance document is intended to be used together with the CTD guidances, described below, and when finalized, it will supercede Guidelines on Formatting, Assembling, and Submitting of New Drug and Antibiotic Applications (February 1987) and the guidance for industry, Organization of an ANDA (February 1998).

Scope & Applicability

Regulatory Context

• 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 →

• 21CFR314.94§ 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 →

• 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.

  (a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →

• 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .

  The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →

• Collection of Race and Ethnicity Data in Clinical Trials: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
• Study of Sex Differences in the Clinical Evaluation of Medical Products (Status: Draft)
• Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (Status: Final)
• Format and Content of the Clinical and Statistical Sections of an Application (Status: Final)
• Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry (Status: Final)
• Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability (Status: Final)
• Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications: Guidance for Industry (Status: Final)
• Submission of Abbreviated Reports and Synopses in Support of Marketing Applications. (Status: Final)