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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
Provisional registration: involves early access to vital and life-saving medicines through time-limited registration
Registration of NCEs, 2020
Evaluation commenced: 31 Jan 2019
Registration decision: 17 Jan 2020
Date registered: 17 Jan 2020
Approval time: 222 working days (255)
Abbvie Pty Ltd
RINVOQ (modified release tablet) is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs).
RINVOQ may be used as monotherapy or in combination with methotrexate or other conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).
Evaluation commenced: 2 Jan 2019
Registration decision: 16 Jan 2020
Date registered: 17 Jan 2020
Approval time: 220 working days (255)
Celgene Pty Ltd
IDHIFA (film-coated tablet) has Provisional Approval in Australia for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia who are ineligible for haematopoietic stem cell transplant, and who have an isocitrate dehydrogenase-2 (IDH2) mutation confirmed by a validated diagnostic test.
The decision to approve this indication has been made on the basis of preliminary clinical data from a Phase 1/2 clinical trial with a primary endpoint of overall response rate. An improvement in OS or PFS has not been established. The sponsor is required to submit further clinical data to confirm the efficacy and safety of the medicine.
Evaluation commenced: 6 Mar 2019
Registration decision: 15 Jan 2020
Date registered: 16 Jan 2020
Approval time: 189 working days (255)
Novartis Pharmaceuticals Australia Pty Ltd
BEOVU (solution for injection) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).