RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Regulatory NewsRegulatory News

    Australia’s TGA Clarifies Drug Approval Process in New Document

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) this week issued a new question and answer (Q&A) guidance  concerning the registration process for new prescription drugs, as well as how to make changes to an already registered product that involves clinical, nonclin...