What is Product Monograph?
A product monograph is a factual, scientific document on the drug product that, devoid of promotional material, describes the properties, claims, indications, and conditions of use for the drug, and that contains any other information that may be required for optimal, safe, and effective use of the drug. A product monograph should include appropriate information respecting the name of the drug, its therapeutic or pharmacologic classification, its actions and/or clinical pharmacology, and its indications and clinical uses. The monograph should also include contraindications, warnings, precautions, adverse reactions, drug interactions and effects on laboratory tests, symptoms and treatment of overdosage, dosage and administration, storage and stability, pharmaceutical information, dosage forms, pharmacology, toxicology, microbiology, special handling instructions, information on clinical trials, information for the consumer, references, and the dates of the initial printing and current revision.
The product monograph, as a document, will be included by Health Canada as part of the Notice of Compliance respecting a New Drug Submission or, when appropriate, a Supplemental New Drug Submission, an Abbreviated New Drug or a Supplemental Abbreviated New Drug Submission.
The product monograph serves as a standard against which all promotional material, or advertising distributed or sponsored by the sponsor about the drug can be compared.
Product Monograph requirements
The Prime objective of a product monograph is to provide essential information that may be required for the safe and effective use of a new drug.
As far as the health professional is concerned, the information provided should be as meaningful and helpful as possible. However, only those indications and clinical uses that are based on substantial evidence of efficacy and safety and that are the subject of a New Drug Submission, or an Abbreviated New Drug Submission, or a supplement to either submission that has received a Notice of Compliance pursuant to Section C.08.004 of the Food and Drug Regulations, should be included in the product monograph. The product monograph is not intended to serve as a repository of all information currently available on a drug. Nevertheless, it should be borne in mind that the responsibility of a health professional, when prescribing a drug, involves all the relevant facts relating to that use.
When a Product Monograph is Required?
- Atinza can research and prepare draft Product Monographs to accompany NDAs to the TPD. We can accumulate and summarize appropriate toxicological, pharmacological and microbiological data for client’s drug, and recommend dosage regimens, indications, and risk information consistent with information supported by clinical trials.
- Atinza ensures the data and findings presented in client’s product monograph are sufficient and formatted in the required format of the TPD, which minimizes delays in review and expedites market access.