Prescription medicines: registration of new chemical entities in Australia

16 March 2017

Each year, approximately 40 new prescription medicines containing new active substances are registered. These are called New Chemical Entities (NCEs) by the TGA.

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 trade name, sponsor and active ingredient for each medicine reflects the information initially entered in the Australian Register of Therapeutic Goods (ARTG).

Registration of NCEs

Orphan drug orphan drug

2017: Feb Jan

Previous years:2016 2015 2014

February 2017

New prescription medicines containing new active substances in February 2016
Medicine Date registered

ZEMAIRA orphan drug

human alpha-1-proteinase inhibitor

Sponsor: CSL Behring Australia Pty Ltd

For maintenance treatment to slow the progression of emphysema in adults with documented severe A1-PI deficiency and progressive lung disease.

13 Feb 2017

January 2017

New prescription medicines containing new active substances in January 2017
Medicine Date registered



Sponsor: Abbvie Pty Ltd

For the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) with 17p deletion, or patients with relapsed or refractory CLL for whom there are no other suitable treatment options.

5 Jan 2017