Prescription medicines: registration of new chemical entities in Australia
Each year, TGA registers approximately 40 new prescription medicines containing new active substances. We refer to these as New Chemical Entities (NCEs) or New Biological Entities (NBEs).
Some of these NCEs/NBEs are innovative or 'first-in-class', and have been made available to the public for the first time outside the controlled environment of a clinical trial.
This decision by TGA to register a NCE/NBE often comes after years of research and development and following a comprehensive review by TGA scientists and clinicians of the medicine's quality, safety and efficacy.
Throughout the year, we will be publishing information on the new prescription medicines as they are approved. However, it may still be some time before the sponsor (pharmaceutical company) decides to supply the product in Australia.
The trade name, active ingredient, and sponsor for each new prescription medicine reflects the information initially entered in the Australian Register of Therapeutic Goods (ARTG).
Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. TGA works to business target timeframes as well as to legislated timeframes for each category of application. Approval times are underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, the time allocated to the sponsor to respond to requests for information, 'mutual clock stop' periods agreed with the sponsor, or other review activities.
Approval times are reported in the number of TGA working days for each new registration, along with the legislated timeframe (unless otherwise indicated) for that category of application in brackets.
Orphan drug: sponsors receive a fee waiver to help bring medicines for a small population to market
Priority review: involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Registration of NCEs
Evaluation commenced: 22 September 2017
Registration decision: 22 February 2018
Date registered: 23 February 2018
Approval time: 104 working days (255)
Roche Products Pty Limited
Hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.
Evaluation commenced: 3 Jan 2017
Registration decision: 22 Jan 2018
Date registered: 24 Jan 2018
Approval time: 242 working days (255)
Sanofi-Aventis Australia Pty Ltd
Dupixent is indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for chronic systemic therapy. Dupixent is not intended for episodic use.
Evaluation commenced: 1 Aug 2016
Registration decision: 19 Jan 2018
Date registered: 23 Jan 2018
Approval time: 163 working days (255)
Eli Lilly Australia Pty Ltd
Olumiant is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately, or who are intolerant, to one or more disease-modifying anti-rheumatic drugs (DMARDs). Olumiant can be taken as monotherapy or in combination with conventional DMARDs, including methotrexate (MTX).
Evaluation commenced: 31 Jan 2017
Registration decision: 18 Jan 2018
Date registered: 19 Jan 2018
Approval time: 198 working days (255)
cabozantinib (as (S)-malate)
Ipsen Pty Ltd
Cabometyx is indicated for the treatment of advanced renal cell carcinoma (RCC) in adults following prior treatment with vascular endothelial growth factor targeted therapy.
Evaluation commenced: 3 Jan 2017
Registration decision: 2 Jan 2018
Date registered: 3 Jan 2018
Approval time: 218 working days (255)
Merck Serono Australia Pty Ltd
Bavencio is indicated for the treatment of adults and paediatric patients 12 years and older with metastatic Merkel Cell Carcinoma (mMCC).
Evaluation commenced: 28 Feb 2017
Registration decision: 21 Dec 2017
Date registered: 2 Jan 2018
Approval time: 181 working days (255)
glecaprevir / pibrentasvir
AbbVie Pty Ltd
Maviret is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis. This includes patients with HCV genotype 1 infection who were previously treated with either a regimen of an NS5A inhibitor or with an NS3/4A protease inhibitor but not both classes of inhibitors.