Drug & Biologic Product Submissions
This page provides blogs, short videos and recordings focused on industry insights for regulatory requirements and best practices for electronic submission compliance for manufacturers and distributors of drug and biologic products.National Drug Code (NDC) Assignment Guide
Drug Establishment Registration Reporting Requirements
Reed Tech Structured Product Labeling Solutions
Health Canada Releases XML PM Draft Guidance
Following a lengthy period of anticipation, Health Canada has released Draft Guidance Document Preparation of the Product Monograph in Extensible Markup Language (XML) Format and sample files.
Revisions to FDA-Forms 365h and 1571
The US Food and Drug Administration (FDA) has recently made updates to forms 365h and 1571. Form 365h is “Application to Market a New or Abbreviated New Drug or Biologic for Human Use”. These applications are commonly referred to as NDA, ANDA or BLA. Form 1571 is “Investigational New Drug Application (IND)”. These are among the most important eCTD forms involved in your drug or biologic application process.
FDA Releases MoCRA Draft Guidance
On August 7, 2023, the Food and Drug Administration (FDA) released draft guidance providing recommendations and instructions pertaining to the collection and submission of information related to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), specifically, to assist persons submitting cosmetic product facility registrations and product listings to FDA.
FDA has Updated eCTD Guidance to Recommend Structure-Data Files
Effective March 10, 2023, Health Canada changed submission requirements for second-language product monographs for human drugs. This change no longer requires the second language product monograph at the time of submission filing or review. However, both English and French languages need to be on the Drug Product Database (DPD) online and Drug and Health Product Portal (DHPP).
Health Canada Now Requiring Second-Language at Post-Authorization Phase
Effective March 10, 2023, Health Canada changed submission requirements for second-language product monographs for human drugs. This change no longer requires the second language product monograph at the time of submission filing or review. However, both English and French languages need to be on the Drug Product Database (DPD) online and Drug and Health Product Portal (DHPP).
Can’t find what you’re looking for?
Questions? We are here to help. Visit our Knowledge Center or Contact Us.