The Structured Product Monograph is submitted to Health Canada when you are seeking approval to market a new drug or health product in Canada. Health Canada reviews the SPM to ensure the product is compliant with the Food and Drugs Act and related regulations. It’s an important part of the New Drug Submission (NDS) or Natural Health Product Submission (NHP) process.
Here’s a breakdown of what an SPM typically includes:- Product Information
- Clinical Information
- Safety Information
- Manufacturing Details
- Labeling Requirements
The Structured Product Monograph (SPM) is a standardized format used to present the scientific, clinical, and safety information about a product. The goal is to ensure that all necessary details are clearly organized for Health Canada’s review and for future reference by healthcare professionals.
- Regulatory Review: It is submitted to Health Canada to demonstrate the safety, efficacy, and quality of a health product, such as a drug or natural health product (NHP).
- Healthcare Professionals: The SPM is also used by healthcare providers to get key product information for prescribing and patient safety.
- The SPM is submitted through the Health Canada’s Therapeutic Products Directorate (TPD) or Natural Health Products Directorate (NHPD).
- Health Canada has also started accepting SPM for ANDS (Abbreviated New Drug Submission, NDS (New Drug Submission), sANDS, and sNDS for drugs, or a Natural Health Product Submission for NHPs.
- You may need to follow specific guidelines, such as the Guideline on the Information to be Provided in Drug Submissions or Guideline for the Preparation of a Natural Health Product Monograph.
Masuu provides guidance and support to industry stakeholders during the market authorization submission process for health products. This can involve multiple steps in the drug or natural health product submission, and Masuu aims to help ensure the accuracy and completeness of the Structured Product Monograph (SPM).
Guideline https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/master-template.html.