Clinical Trial Applications for Biologics and Radiopharmaceuticals

Clinical Trial Applications for pharmaceutical (Schedule F), radiopharmaceutical (Schedule C) and biological (Schedule D) drugs are all regulated under Part C, Division 5 of the Food and Drug Regulations, and therefore all must adhere to the same regulatory requirements. However, biological drugs carry additional risks associated with complexity and variability in manufacturing that can contribute to increased lot-to-lot variation of the final product, and with the potential for adventitious agents. Other specialized concerns pertain to radiopharmaceutical drugs. Therefore, the content requirements for the quality information for biological and radiopharmaceutical drugs are different from those for pharmaceutical drugs (for example, the inclusion of information on manufacturing facilities is required for biological drugs). In addition, it is necessary to have more stringent controls on the release of biologic and radiopharmaceutical drug lots used in authorized clinical trials.

In light of the above, Biologics and Genetic Therapies Directorate (BGTD ) has developed specific Quality guidance documents to assist sponsors in completing the necessary Quality information for CTAs for these products. BGTD also requires that each lot of drug to be used in an authorized clinical trial be submitted to BGTD for release, prior to use. This process is carried out via one of two mechanisms:

1. For vaccines, BGTD requires the submission of product samples for lot release testing, and the lot in question can only be used after a Release letter is issued by BGTD.
2. For all other products, BGTD requires the submission of a Clinical Trial Fax-Back Form, which certifies that the drug lot meets Release specifications, and the lot in question can only be used after the Fax-Back form is acknowledged by BGTD.

In certain situations, where test results may not be available prior to product administration (e.g. cell therapies, radiopharmaceuticals with very short radioactive half-lives), special arrangements can be made to satisfy BGTD requirements.