This course provides a comprehensive overview of the regulatory requirements for generic drugs including the development, submission process, and approval of generic drugs. Throughout the course, students will gain a practical understanding of the regulatory landscape for generic drugs, including the roles of Health Canada, the Patented Medicine Prices Review Board (PMPRB), the Canadian Agency for Drugs and Technologies in Health (CADTH), US-FDA and European regulators.
The process of developing a generic drug, including the requirements for formulation development, stability testing, and analytical testing as well as the importance of the regulatory strategy in the development process will be discussed in details.
Students will learn about the concept of bioequivalence, which is a critical requirement for the approval of generic drugs. They will understand how to conduct bioequivalence studies and how to interpret the results. Students will also gain an understanding of biosimilars, which are becoming increasingly important in the generic drug market. They will learn about the regulatory requirements for the approval of biosimilars, including the need for comparative clinical studies.
Additionally, students will learn about the submission process for generic drugs, including the requirements for an Abbreviated New Drug Submission (ANDS) and the importance of providing comprehensive supporting data. They will also understand the review process and how to respond to requests for additional information.
Learning Points
Overall, this course provides students with a thorough understanding of the regulatory requirements for generic drugs globally, enabling them to navigate the complex regulatory landscape and effectively manage the development and approval of generic drugs.
