Risk-based Approach to Site Licensing (RBASL) for NHPs
Health Canada has issued an update of work currently underway to build an enhanced Risk-Based Approach to site-licensing (RBASL) for manufacturers, packagers, labellers and importers of natural healt...
Health Canada adopts ICH Q4B
Health Canada has adopted the ICH guidance on the Evaluation and Recommendation of Pharmaceutical Texts for use in the ICH regions:
• Residue on Ignition/Sulphated Ash - General Chapter - Q4B Annex 1(R1)
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If you have questions on Canadian Drug GMPs that are not addressed by Health Canada’s published guidance documents; DSA offers a range of services related to obtaining, clarifying, or challenging regulatory interpretations from Health Canada. In fact, on behalf of our clients, we’ve already been successful in challenging some of the answers published in the GMP Q&A and other rulings related to the 2009 GMPs.
