Intrinsik’s What’s New – 2nd Regulatory Edition 2025 – Health Canada and FDA Updates

Intrinsik’s What’s New – 2nd Regulatory Edition 2025 – Health Canada and FDA Updates

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What’s New Regulatory Edition FDA Updates Guidance Documents

1. Study Data Technical Conformance Guide – Technical Specifications Document

This final guidance [Version 6.0, dated March 2025] provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog (Catalog). The Guide supplements the guidance for industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data (eStudy Data). The eStudy Data guidance implements the electronic submission requirements of section 745A(a) of the Food, Drug, & Cosmetic (FD&C) Act with respect to standardized study data contained in certain INDs, NDAs, ANDAs, and BLAs that are submitted to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This Guide supersedes all previous Study Data Specifications documents (Versions 1.0 – 2.0) and CDER Study Data Common Issues Documents (Versions 1.0 -1.1).

2. Evaluation of Sex-Specific Data in Medical Device Clinical Studies – Guidance for Industry and Food and Drug Administration Staff

This final guidance document [issued on March 31, 2025] outlines the FDA’s expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information. The primary intent is to improve the quality and consistency of available data regarding the performance of medical devices in both sexes by encouraging appropriate enrollment by sex in clinical studies of devices, and that data from such studies is appropriately analyzed by sex. This information can be of benefit to patients and their medical providers, as well as clinical researchers and others.

 

What’s New Regulatory Edition Health Canada Updates General Notices

1. Updated: Regulatory Transaction (RT) Template (Version 5.0)

Note: The updated RT template and stylesheet was posted on March 26, 2025.

• Added instructions regarding the “Load a regulatory transaction enrolment file” section
• Reordered “Transaction details” section
• Added info bubble for the control number
• Removed the regulatory activity type: NDS CV
• Added regulatory transaction description: Request for review report(s) to lead: Postmarket vigilance (for Marketed Health Products Directorate (MHPD))
• Removed the question “Are there new or revised fees associated with this transaction?”
• Added submission class: Not applicable
• Removed routing identifier
• *New RT stylesheet to match changes on this template

2. Health Canada drafts guidance on co-packaged drug products: Notice

Health Canada has drafted a guidance document on co-packaged drug products. This document explains the regulatory requirements for co-packaged drug products and their components. This draft guidance is open for consultation until May 18, 2025.

3. Notice of intent: Removing carisoprodol from the Prescription Drug List

The purpose of this Notice of Intent is to announce that Health Canada will remove carisoprodol from the human and veterinary parts of the Prescription Drug List (PDL) on April 14th, 2025, the date on which the Ministerial Order comes into force to add carisoprodol to Schedule V of the Controlled Drugs and Substances Act (CDSA)

 

Health Canada Updates Guidance Documents

1. Guidance Document: Preparation of the XML Product Monograph (XML PM)

Guidance document & samples: XML Product monograph (available upon request ). Please ensure the text ‘Guidance document Preparation of the XML Product Monograph’ is in the subject line of the email. [2025-03-28]

2. Updated guidance document: Regulatory enrolment process (REP) for drugs for human/veterinary use, disinfectants and biocides

Guidance document: Regulatory enrolment process (REP): Drugs for human/veterinary use, disinfectants and biocides (available upon request ). Please ensure the text ‘REP Guidance document’ is in the subject line of the email. [2025-03-17].

3. Guidance on the Food and Drug Regulations for public health emergency drugs: Overview

This guidance document [published: March 2025] will help sponsors prepare a submission for a notice of compliance for a public health emergency drug (PHED) under the regulations. It also outlines the process for meeting the post-market regulatory requirements.

This guidance document applies to:

• Sponsors planning to file a submission for a notice of compliance (NOC) for a PHED as defined in C.08.001.1 of the regulations
• A submission for a PHED that has been filed and/or authorized
• Establishments seeking a drug establishment licence (DEL) related to a PHED
• Pre-positioning of a PHED (C.08.009.01 to 05)

This guidance document does not apply to drug submissions that are substantively not related to a PHED and a condition on the list: List of conditions that threaten public health in Canada.