Product Monograph: Canada
An integral part of a NDA is the product monograph, which is a comprehensive summary of information about the new drug. After the new drug is approved by the TPD, the product monograph should be provided to any health professional requesting information about the drug, and parts of the product monograph may also be included as package inserts to be provided in connection with any promotion or advertisement of the drug.
The product monograph is a highly scientific document composed of three sections: Health Professional Information; Scientific Information, and Patient Medication Information. In addition to the name, actions, dosage, and indications for the new drug, the product monograph also summarizes the toxicology, pharmacology, risk information (contraindications, warnings, adverse reactions, drug interactions, overdose symptoms and treatment), microbiology, handling instructions, clinical trial data, and patient information.
NHP Consulting can research and prepare draft Product Monographs to accompany NDAs to the TPD. We can research and summarize appropriate toxicological, pharmacological and microbiological data for your drug, and recommend dosage regimens, indications, and risk information consistent with information supported by high-quality clinical trials. We can ensure the data and findings presented in your product monograph are current and formatted in the preferred style of the TPD, which minimizes delays in review and expedites market access.
NHP Consulting can prepare a product monograph and any OTC drug submission.