TY - JOUR AU - S. Chitte, Swapnil AU - Patil , Pratibha U. AU - A. Chandramore, Mansi AU - Menon, Gowtham AU - Shendge , Raosaheb S. AU - Salunkhe , Kishor S. PY - 2023/01/11 Y2 - 2024/03/29 TI - Regulation for the New Biologically Originated Allergenic Products for the Treatment or Diagnosis of Allergic Disorders JF - Journal of Coastal Life Medicine JA - JCLM VL - 11 IS - 1 SE - Articles DO - UR - https://www.jclmm.com/index.php/journal/article/view/557 SP - 1587 - 1600 AB - <p>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.&nbsp; 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.</p> ER -