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Prescription medicines: registration of new chemical entities in Australia

11 March 2021

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.


symbol denoting an orphan drug

Orphan drug: sponsors receive a fee waiver to help bring medicines for a small population to market

symbol denoting a priority determination

Priority review: involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available

symbol denoting a provisional registration

Provisional registration: involves early access to vital and life-saving medicines through time-limited registration


Registration of NCEs, 2021

Previous years

2020 2019 2018 2017 2016 2015 2014

February 2021

COVID-19 VACCINE ASTRAZENECA provisional registration

Evaluation commenced: 1 Dec 2020

Registration decision: 15 Feb 2021

Date registered: 16 Feb 2021

Approval time: 48 (255 working days)

chadox1-s

AstraZeneca Pty Ltd

COVID-19 VACCINE ASTRAZENECA (solution for injection) has provisional approval for the indication:

  • Active immunisation of individuals ≥ 18 years old for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

The use of this vaccine should be in accordance with official recommendations.

The decision has been made on the basis of short term efficacy and safety data. Continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

VOCABRIA

Evaluation commenced: 31 Oct 2019

Registration decision: 10 Feb 2021

Date registered: 16 Feb 2021

Approval time: 253 (255 workign days)

cabotegravir

ViiV Healthcare Pty Ltd

VOCABRIA (tablet) are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA

  • oral lead in to assess tolerability of cabotegravir prior to administration of cabotegravir prolonged-release suspension for injection plus rilpivirine prolonged-release suspension for injection.
  • oral therapy for adults who will miss planned dosing with cabotegravir prolonged-release suspension for injection.

POTELIGEO orphan drug

Evaluation commenced: 1 Apr 2020

Registration decision: 6 Jan 2021

Date registered: 5 Feb 2021

Approval time: 167 (175 working days)

mogamulizumab

Kyowa Kirin Australia Pty Ltd

POTELIGEO (concentrate for solution for infusion) is indicated for the treatment of adult patients (≥18 years of age) with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

January 2021

COMIRNATY COVID-19 VACCINE provisional registration

Evaluation commenced: 2 Nov 2020

Registration decision: 25 Jan 2021

Date registered: 25 Jan 2021

Approval time: 55 (255 working days)

bnt162b2 (mrna)

Pfizer Australia Pty Ltd

COMIRNATY (BNT162b2[mRNA]) COVID-19 Vaccine (concentrated suspension for injection) has provisional approval for the indication below:

  • Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 16 years of age and older.
  • The use of this vaccine should be in accordance with official recommendations.

The decision has been made on the basis of short term efficacy and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.

AKLIEF

Evaluation commenced: 30 Apr 2020

Registration decision: 11 Jan 2021

Date registered: 18 Jan 2021

Approval time: 166 (175 working days)

trifarotene

Galderma Australia Pty Ltd

AKLIEF (cream) is indicated for the topical treatment of Acne Vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and/or pustules are present.

TRIENTINE WAYMADE orphan drug

Evaluation commenced: 30 Jan 2020

Registration decision: 7 Jan 2021

Date registered: 11 Jan 2021

Approval time: 188 (255 working days)

trientine dihydrochloride

Waymade Australia Pty Limited

TRIENTINE WAYMADE (capsule) is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine.