Medicines Regulation Division (MRD) is responsible for undertaking evaluations of applications to approve new medicines for supply in Australia. Senior managers in MRD make decisions whether to approve or reject market authorisation of medicines that are imported, exported, manufactured and supplied in Australia.
MRD also has responsibility for ongoing monitoring of medicines approved for supply in Australia to ensure they continue to maintain an appropriate level of quality, safety and efficacy following entry into the Australian marketplace.
The Division comprises:
- Prescriptions Medicines Authorisation Branch
- Complementary and Over-the-counter Medicines Branch
- Scientific Evaluation Branch
- Pharmacovigilance and Special Access Branch