Drug Regulatory Requirements for Canada
Navigating through Canadian Drug Regulatory Processes
AXSource Consulting Inc. helps its client manufacturers navigate through all the hurdles in the drug regulatory process. These usually include initial product classification, coordinating with Health Canada and consulting with drug manufacturers for successful market authorization, management of Health Canada regulatory filings for pre-market clinical trial, market authorization and post market changes. By enlightening drug manufacturers about regulatory requirements, time frames and Health Canada costs, AXSource Consulting helps businesses establish a feasible plan to meet their goal.
This AXSource expertise is of significant value to health care product manufacturers interested in the Canadian market as the product’s classification dictates the regulatory submission / application type and influences the government time frames, fees and regulatory requirements specific to the product. For instance, an oral daily intake of vitamin D above 1000IU could require a new drug submission (NDS) but the same ingredient below this range would require a product license application (PLA). While a PLA currently has no government processing fee and takes around 120 days for review by Health Canada, a new active substance currently costs $309, 550 and can take 300 days for Health Canada’s review.
In a day when drug-drug, drug-medical device combinations exist, product classification needs an accurate interpretation of the regulations especially as drugs themselves can have diverse classifications. Drugs include pharmaceuticals, biologics (e.g. blood components, monoclonal antibodies), radiopharmaceuticals, disinfectants, natural health products (e.g. vitamins, minerals), controlled drugs (e.g. testosterone). Drug manufacturers can rest at ease as AxSource consultants frequently classify several drug combination products.
Pre-market preparation and Market Authorization
After product classification, the next step for many drug classes would be preparing for and filing the market authorization application or submission. The market authorization applications vary with drug class. A pharmaceutical or biologic new drug requires a NDS while a generic requires an abbreviated new drug submission (ANDS) while a disinfectant drug would require a drug identification number (DIN) submission.
Based on the product class and submission type, AXSource consultants establish the regulatory requirements, Health Canada time frames and costs and evaluate the product’s data as they become available. For a new drug, safety, efficacy and quality are evaluated and include pre-clinical pharmacokinetic data (absorption, distribution, metabolism, excretion of a drug), pharmacodynamic data (drug concentration–effect response), toxicology data, reports from clinical studies, manufacturing processes and process controls, validation of analytical procedures, characterization of the drug substance and product, etc. In comparison to the NDS, ANDS requirements are less burdensome and focus on proving pharmaceutical equivalence to marketed brand drugs through bioequivalence dissolution studies. Disinfectant drugs are the least stringent requiring mainly efficacy data.
AXSource consultants are adept in other market preparation regulatory activities like the evaluation of and guidance on labeling and promotional materials, coordinating with Health Canada on pre-submission meetings, filing clinical trial applications (CTA) if needed and finally filing the market authorization application for Health Canada’s Notice of Compliance (NOC) and DIN issuance. AXSource consultants also file applications for establishment licenses needed to conduct drug fabrication, packaging, labeling, import and distribution activities.
Regulatory Filings for Post-Market Changes
Several changes can occur post market and require regulatory filings to Health Canada. Examples include changes in manufacturer or drug name, formulation, analytical procedures, manufacturing processes, equipment used in fabrication, etc. The nature of the change, product class / submission type determine the nature of the regulatory filing. AxSource consultants help drug manufacturers with all post market change filings including supplemental new drug submissions (SNDS), supplemental abbreviated new drug submissions (SANDS), notifiable changes (NC), annual notifications and post DIN changes (PDC).
Thus, AXSource Consulting navigates through Canadian drug regulatory processes for its clients to help them effectively meet their goals.