The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
The application phases for a new registered complementary medicine are as follows:
- Phase 1: Pre-submission meeting (recommended)
- Phase 2: Submission of application and payment of application fee
- Phase 3: Screening of application, determination and receipt of evaluation fee
- Phase 4: Evaluation
- Phase 5: Decision
- Phase 6: Implementation
Note that you may choose to withdraw your application at any phase.
Chart D1 illustrates the application phases for a new registered complementary medicine.
Chart D1: New registered complementary medicine application process flow chart
Text version of Chart C1
Phase 1: Pre-submission meeting
It is recommended that you arrange a meeting prior to submitting your application for a new registered complementary medicine. The intention of the meeting is to assist you to submit a high quality, complete dossier. Discussion will focus on the structure of your proposed application, the identification of critical issues and the suitability of your proposed approach. It should be noted that no assessment or evaluation of data will be undertaken as part of a pre-submission meeting.
You should contact the TGA to arrange a meeting - there is no fee associated with a pre-submission meeting. For more information on the conduct of meetings - refer to Pre-submission meetings with TGA.
Phase 2: Submission of application and payment of application fee
Your application for a registration of a complementary medicine has to be submitted electronically via the TGA Business Services portal. You require a user name and password to access TGA Business Services, which is obtained by submitting an 'Organisation Details Form' followed by an 'TGA Business Services Access Request Form'.
Your application must be accompanied by an 'application fee' (non-refundable) and the dossier. Information on current fees can be found on the TGA website.
TGA will acknowledge receipt of your application.
Phase 3: Screening of application, determination and receipt of evaluation fee
The screening of your application consists of an administrative and a technical screen.
In general, screening aims to identify firstly, whether your application is considered 'not effective' as determined under 23 (2) of the Act:
23 (2) An application is not effective unless:
- the prescribed application fee has been paid; and
- the applicant has delivered to the office to which the application was made such information, in a form approved, in writing, by the Secretary, as will allow the determination of the application; and
- (ba) if the application is for the registration of restricted medicine - the application is accompanied by product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine; and
- if the Secretary so requires - the applicant has delivered to the office to which the application was made a reasonable number of samples of the goods.
The screening phase determines that:
- all required fields on your application form have been completed
- you have paid the 'application fee'
- your dossier provides sufficient information
- the route of evaluation for the application is appropriate.
If your application is considered 'not effective' (and therefore not suitable for evaluation as a new registered complementary medicine) you will be informed of the reasons for this decision.
A decision that an application is 'not effective' is not included in the appeal provisions under subsection 60(1) of the Act. Therefore you do not have a right of review under section 60 of the Act, but you do have a right to apply to the Federal Court on questions of law.
If your application is considered 'effective' (and therefore, acceptable for evaluation) the TGA determines the 'evaluation fee' payable. The 'evaluation fee' is in addition to the 'application fee' and is based on the number of pages of clinical and nonclinical data submitted (administrative and quality data are excluded from the page count). The following types of safety data count towards the calculation of evaluation fees:
- biological activity/pharmacodynamics
- pharmacokinetics
- animal/toxicological studies
- bioavailability/bioequivalence study
- human data
- published papers and reviews
- meta-analysis reports
- literature search strategy and results
- expert overviews/summaries/reports
- case reports and adverse reaction reports.
You should submit all relevant data at the time the application is lodged. The omission of such data may jeopardise the success of your application.
In some cases, where an application is found to be suitable for evaluation, the screening may identify minor errors or omissions that can be readily addressed. In this circumstance, you will be advised that the application has been accepted for evaluation, and be given the opportunity to address these minor errors or omissions.
You will be notified in writing regarding the acceptance of your application for evaluation and the applicable evaluation fee. The evaluation process will not commence until you have paid the evaluation fee in full. Your application will lapse if evaluation fees are not paid within two months of becoming payable. In this case, you will be notified that your application has lapsed and advised that, should you wish to continue, a new application will be required.
Phase 4: Evaluation
In the evaluation stage, the quality, safety and efficacy of the proposed new registered medicine are critically assessed and an evaluation report is produced.
Quality
The data are evaluated to determine the quality of the medicine, including the identity, impurities and stability of all ingredients. The assessment also takes into account information about the manufacturing processes and the compliance with good manufacturing practice (GMP). Quality-control measures are assessed to determine if the medicine will be produced to a consistent quality. Stability data for the medicine are evaluated to confirm that the medicine is of appropriate quality over its proposed shelf-life.
Safety
History of use, biological activity, toxicology, clinical trials and reports of adverse reactions are assessed to determine the safety of the medicine.
Efficacy
The assessment of the efficacy data includes a detailed evaluation of the proposed indication(s) and any claims that you intend to make for the medicine to determine whether the data supplied adequately support the requested indication(s)/claim(s).
Where the evidence is considered not likely to support the proposed indication, you will be advised in writing and asked whether you wish to amend the indications in line with the available evidence.
Medicine presentation, Consumer Medicine Information and Product Information
All aspects of the medicine presentation, including proposed labelling, are assessed for compliance with the various legislative requirements (including advertising requirements) and to ensure clarity is provided for consumers in relation to the medicine and its proposed use.
When provided, Product Information and Consumer Medicine Information are also assessed.
During evaluation, the evaluator will identify any matters that require clarification or information, and where necessary a consolidated set of questions will be prepared by the TGA delegate and sent to you (under Section 31 of the Act).
Possible consideration by a TGA advisory committee
In some circumstances the Delegate for the Secretary of the Department of Health (the Delegate) may seek advice from a TGA advisory committee in relation to an application. In this situation, you will be informed that the committee's advice is being sought and you may choose to provide comment for the committee's consideration. Subsequently you will be informed of any relevant advice given by the committee.
Phase 5: Decision
In making a decision on the application, the Delegate will take into consideration the evaluation report, any advice given by the advisory committee and any subsequent comment provided by you. The decision to register the medicine may be a complex one and is based on the need for the medicine and its benefit-to-risk ratio.
You will be advised in writing of the Delegate's decision. If the decision is to reject the application, the letter will provide the reasons for the decision. If the decision is to approve the application, the standard and specific conditions of registration will be provided.
If you do not agree with the decision of the Delegate, you have the right to appeal under Section 60 of the Act.
Phase 6: Implementation
The decision letter will include a request for the future sponsor of the medicine to provide assurance that all details of the medicine are correct prior to the medicine being entered on the ARTG. After being entered, a registration certificate will be available online for printing by the sponsor. The registration of therapeutic goods begins on the day specified in the certificate of registration and remains valid until suspended or cancelled. Annual renewal charges will apply while the medicine remains registered on the ARTG.