Evaluation of Health Canada
All drug submissions must undergo rigorous scrutiny, thorough review and fully satisfy all scientific requirements under the Food and Drug Regulations of Health Canada before it can be marketed in Canada.
All drugs sold in Canada, whether generic or brand name, must be approved by Health Canada’s Therapeutics Products Directorate (TPD) or the Natural and Non-prescription Health Products Directorate (NNHPD). They must also meet strict guidelines established by Canada’s Food and Drug Act and Regulations.
In terms of quality, purity, efficacy and safety, generic drugs and their brand name should be comparable equivalent. The only difference is price. Most generic drugs are generally less expensive.
The application process to get market authorization to sell a generic drug in Canada requires manufacturers to prove that their drug is as safe and effective as its brand name equivalent.
The Food and Drug Regulations of Health Canada provides the regulatory framework for the registration and sale of drug products in Canada. Atinza can handle all aspects of compliance with Health Canada from drug registrations through to drug approvals and post-approval changes.
Atinza is experienced in Canada regulatory laws, guidelines and policies—both federal and provincial—and regularly advise on all of the regulatory issues affecting the research, testing, approval, post-approval compliance, pricing, advertising and correction/withdrawal/recall of drugs in Canada.
Post-marketing Services
Atinza can also extend our support to post-market processes, ensuring that products successfully registered with regulatory authorities remain in compliance throughout their life-cycle, avoiding the risk of recalls. In the event a recall is ordered (or suspected necessary) for your product, we can support you throughout the process. We will firstly determine whether it is necessary or not. In case a recall is unavoidable, we will communicate with regulatory authorities and consumers on your behalf.