Regulation for the New Biologically Originated Allergenic Products for the Treatment or Diagnosis of Allergic Disorders

Abstract

The main objective of these analyses is to provide a regulatory framework for biological allergenic products and the management of their lifecycle. And also provide the information required in new drug submissions or clinical trial applications.  Unauthorized allergenic products are regulated by Health Canada’s Food and Drug Act and Part C of the Food and Drug Regulations as Schedule D (biologic) drugs. The laws and regulations for the development and sale of allergenic products of biological origin must be developed and implemented by Health Canada. There is a lengthy approval procedure for new allergenic products at Health Canada based on a thorough examination of the quality, safety, and efficacy evidence.