October 5th the FDA released the anticipated “eCTD Technical Conformance Guide” to be followed when submitting to CDER or CBER following requirements established in section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
This guidance is to be used along with the final guidance to Industry “Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications”. These two guidance’s are applicable to drugs, biologics, generics, and certain investigational products regulated by CDER and CBER.
The electronic Common Technical Document (eCTD) has been accepted by the FDA for nearly 10 years, however with the issuance of the final guidance document under 745A(a) of the FD&C Act, all submissions to the FDA that fall within the requirements of the act for CDER and CBER will be required in eCTD format within 24 months, or May 2017. Additionally, under the new Module 1 v. 3.3, the submittal of Advertising and Promotion (Ad/Promo) material in eCTD format is accepted however not required, as the guidance document is still in draft. These Ad/Promo submissions apply to submissions made to the Office of Prescription Drug Promotion (OPDP) at CDER and the Advertising and Promotional Labeling Branch (APLB) at CBER.
Paragon Solutions has extensive experience in eCTD submissions and regulatory operations and can provide the following services to help prepare:
- eCTD Compliance Assessments
- Process Development, Best Practices, and Training
- Template Review and Development
- Vendor Tool Selection Process
- Transition to Module 1 V. 3.3
- Ad/Promo submission transition, training, best practices