Regulatory Chemistry, Manufacturing and Control (CMC) requirements determine the strategy parameters for new pharmaceutical process development and changes post approval. Knowledge of CMC requirements and relevant agencies is a key success factor in pharmaceutical approval and compliance. In particular, globalization has caused a significantly more complex regulatory environment for the manufacture and distribution of pharmaceuticals (and medical devices). Most product supply chains are now multinational with increasing trends towards investment in rapidly developing but poorly regulated nations. The development of regulatory strategies for product development and post approval changes requires the understanding of many national regulatory agencies and international harmonization efforts. The advent of Biosimilars will place increased emphasis on CMC product characterization and process comparability and/or interchangeability as the key criteria for introduction of “generic” biologics. (MEB 403)
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