Prescription medicines: registration of new chemical entities in Australia

Each year, approximately 40 new prescription medicines containing new active substances are registered. The Therapeutic Goods Administration (TGA) call these New Chemical Entities (NCEs). Some of these NCEs are innovative or ‘first-in-class’, and have been made available for the first time outside the controlled environment of a clinical trial. This decision by the TGA often comes after years of research and development and following a comprehensive review by the TGA scientists and clinicians of the quality, safety and efficacy of the new prescription medicines. Throughout the year we will be publishing information on the new prescription medicines when they are approved. However, it may still be some time before the pharmaceutical company decides to supply the product in Australia. The Prescription medicines: annual summary 2014 publication provides details of NCEs registered in 2014. Prescription medicines: annual summary 2014. Registration of new chemical entities in Australia (pdf,727kb)

TGA, 5 May 2015 ;http://www.tga.gov.au/ ;