Open Access Open Access  Restricted Access Subscription or Fee Access

Key Regulatory Requirements and Guidelines for the Registration of a Drug in Canada

Sharin Thomas, Mudit Dixit, Rohit Dixit, R. Narayana Charyulu


Drug product registration is an important step in the process of a drug development from raw material to finished product to making it available to the public. Drug regulatory authorities play an important role in this process. Health Canada is the regulatory authority in Canada which manages the drug submission and approval of drug product in Canada. The guidelines from the Food and Drugs Act and Regulations for drug products are reviewed. An application to Health Canada (HC) to market a new drug in Canada is done by the sponsoring pharmaceutical company; the application typically includes animal data, chemistry and manufacturing data, and the results from clinical trials of various phases. The Therapeutic Products Directorate (TPD) is responsible for the regulation of prescription and non-prescription pharmaceutical (i.e. chemically synthesized) products and medical devices. The Common Technical Document for Registration of Pharmaceuticals for Human Use (International Conference on Harmonization [ICH] Topic M4) was adopted by Health Canada, in 2003, for use in the preparation of drug regulatory activities. Module 1 is region specific, while Modules 2, 3, 4, and 5 are intended to be common for all regions. A regional component is included in Module 3. The review of information provided in a well-structured regulatory activity will improve the efficiency of the screening and review of that regulatory activity.

Keywords: Health Canada, TPD, ICH, Drug Product, NDS

Cite this Article

Thomas Sharin, Dixit Mudit, Dixit Rohit, et al. Key Regulatory Requirem-ents and Guidelines for the Registration of a Drug in Canada. Research & Reviews: A Journal of Drug Formulation, Development and Production, 2015; 2(2): 28–37p.



Full Text:



  • There are currently no refbacks.