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MCC Registrar of Medicines Response


26 April 2012 - The South African Medicines Control Council (MCC) Registrar of Medicines responded to the TB CAB stating that the current available data is limited and premature and that they believe providing patients with access to bedaquiline would be better achieved through an open label clinical trial design. The letter also stated that the National Department of Health is planning to submit a clinical trial protocol for review to the MCC and relevant ethical committees and that once received the review will be expedited.


The Letter as pdf