Updated Obligations for Drug Shortage in Australia

| By | Australian Pharma, Drug Shortage, Guidance, Regulatory

The Australian medicines regulator has updated its guidance on reporting obligations for pharmaceutical companies, mandating confidential reporting of all shortages.

The document, published by the Therapeutic Goods Administration (TGA), sets out the mandatory reporting scheme for shortages or permanent discontinuation of medicines, and the TGA’s approach to non-compliance with that scheme.

While a voluntary notification scheme was introduced in 2014, where sponsors were encouraged to notify the TGA of medicine shortages, it was found by a working group to be insufficient.

More information on reporting requirements and obligations can be found on the TGA website.

SOURCE: the pharma letter
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