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Assessed listed medicines evidence guidelines

Version 1.1, August 2018

17 August 2018

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9. Application and approval processes

All medicine applications that involve pre-market assessment by the Complementary and Over the Counter Medicines Branch (COMB) follow a similar sequence of processes. The main difference between applications of different types is that applications in lower categories have shorter assessment timeframes due to the reduction in information to be evaluated. The steps involved in most applications are:

The sections below provide further information on each of these steps.

9.1 Pre-submission

9.1.1 Verifying eligibility and validity

Before submitting an application, potential sponsors should ensure that the proposed product meets the eligibility requirements for the assessed listed medicines pathway.

Checking ingredients

All ingredients (active and excipients) must be included in the latest Therapeutic Goods (Permissible Ingredients) Determination and the formulation must be compliant with any restrictions or requirements associated with those ingredients.

If the product contains any ingredient not specified in the Determination, applicants will need to submit an application for a new substance for use in listed medicines prior to proceeding, or alternatively submit an application for a registered complementary medicine.

If the medicine contains any proprietary ingredients (PIs) - including flavours, fragrances and printing inks - applicants will need the proprietary ingredient ID number. PIs are listed in the Proprietary Ingredients Table. If the PIs are new (i.e. not in the Code tables), applicants must submit the completed Notification of a Proprietary Ingredient form to obtain a PI ID number.

New PIs intended for use in listed medicines must only contain ingredients specified in the Therapeutic Goods (Permissible Ingredients) Determination. If this is not the case, applicants will need to submit an application for a new substance for use in listed medicines. Note that the application for an assessed listed medicine cannot proceed until the ingredient has been successfully evaluated and added to the Determination. This may cover a significant period of time.

All substances in a PI intended for use in listed medicines must be included in the Therapeutic Goods (Permissible Ingredients) Determination. It is the sponsor's responsibility to confirm that the PI does not contain any ingredients not on the Determination, and that warning statements related to any PI components that need to be declared are included on the label.

Checking the indications and claims

Applicants must ensure that the indications and claims on the label are appropriate for the assessed listed medicines pathway and that they correctly align with the evidence supplied in the application. This includes ensuring that the formulations, dosage, route of administration, and target populations are all substantially similar to those employed in the studies. If the indications or claims include restricted representations, a request for approval of the representation must be included in the application (see Advertising - Restricted representations).

Checking evidence

Applicants should check the minimum data requirements for the method by which they intend to support the efficacy claims. For an application to be considered to be effective, it must contain the correct type, number and quality of studies; the correct type of pharmacokinetic/ biopharmaceutic studies; and GMP clearance valid for the entire duration of evaluation. If the GMP clearance is due to expire within the minimum timeframe or is likely to expire before the application is finalised, applicants should either apply to renew the GMP clearance or seek an extension to the GMP clearance expiry before submitting the application.

It is recommended that applicants check all of the relevant European Union and ICH guidelines adopted in Australia for any specific requirements that may apply.

Label proofs

Proofs of the proposed labels must be submitted. The labels should comply with the relevant Therapeutic Goods Orders and must include at least one intermediate level indication. All indications and claims on the label will be assessed by the TGA. Only assessed indications will be included in the ARTG entry for the product if it is approved.

9.1.2 Determining the application category and compiling the dossier

There are three categories for applicants to list medicines based on risk, with L(A)1 being the lowest and category L(A)3 being the highest risk. The data requirements and timeframes increase with the level of assessment and risk mitigation required.

It is important that applicants determine the application category correctly. If the application does not meet the requirements of the selected category, and does not include the required data, it will not be accepted for evaluation. To help determine the correct application category, refer to Application categories for assessed listed medicines.

The assessed listed medicines pathway uses a simplified version of the CTD format for organisation of evidence. The application should be prepared following the Application dossier requirements.

9.1.3 Pre-submission meeting

Applicants can arrange a free optional pre-submission meeting with the TGA prior to submitting the application for a new assessed listed medicine.

Pre-submission meetings are not mandatory but are strongly recommended. They provide an opportunity for applicants to seek clarification of the requirements and to revise the approach to their application. These meetings may help applicants submit a high quality and complete dossier, and consequently ensure that the evaluation process proceeds smoothly and in line with legislated timeframes.

During the pre-submission meeting, discussion will focus on the structure of the proposed application, the identification of critical issues and the suitability of the proposed approach. The TGA does not assess or evaluate the application as part of a pre-submission meeting.

After the meeting, the applicant forwards minutes of the meeting to the TGA and any other participants. If necessary, the final meeting record should be included in Module 1 of the application dossier.

To arrange a free meeting with the TGA, follow the general guidance on pre-submission meetings.

9.2 Application submission

9.2.1 Completing and submitting the application

Applications are created and lodged through TGA Business services. Applicants will need a Client ID number and a password access to the TGA Business services. Applicants who do not have a Client ID number or access to TGA business services should submit the online organisation details form.

The Guidance for completing the application form for an assessed listed medicine provides instructions on completing the application form for the listing of the assessed listed medicine.

Once the application has been submitted, applicants will be issued with a unique submission number that can be used in all future communications about the application.

Withdrawing an application

An application can be withdrawn at any time up until the decision is made. This can be done through the Business Services. Alternatively, applicants can advise the TGA in writing of the intention to withdraw the application.

When an application is withdrawn, the TGA may retain the application and any material submitted in connection with the application.

9.2.2 Application fee payment

Once an application has been received by the TGA, an invoice will be issued for the application fee. For details of the current fees, refer to Schedule of fees and charges.

For information on fees and the available payment methods see:

The TGA will not commence screening the application until the application fee has been paid.

9.3 Preliminary assessment

The TGA will conduct a preliminary assessment of the application to determine whether it meets the administrative requirements and basic technical eligibility requirements (e.g. correct application type and application fee, and adherence to the Mandatory requirements for an assessed listed medicine application to pass preliminary assessment, CTD Module 1: Administrative information for assessed listed medicines and General dossier requirements) to proceed to evaluation. This is simply a quality assurance process, and no evaluation of the scientific content of the application is undertaken at this point.

9.3.1 Applications that pass preliminary assessment

The application will pass preliminary assessment if it meets the requirements under section 23B of the Act. Generally, this means that:

  • the prescribed application fee has been paid; and
  • the application includes all required information, for the correct application category, to enable the TGA to evaluate the application.

Applicants will have an opportunity to make minor corrections detected during the screening process if the issue can be rectified promptly. For example, if the evaluators cannot locate an attachment mentioned in the application, the TGA will provide an opportunity to submit the attachment.

If the application passes preliminary assessment, the applicant will be notified in writing that the application has been accepted for evaluation and an invoice will be issued for the evaluation fee. The evaluation process will not commence until the evaluation fee has been paid in full.

9.3.2 Applications that do not pass preliminary assessment

If the application does not pass preliminary assessment, it will not be accepted for evaluation. The applicant will be notified in writing and an explanation of why the application was not effective will be provided. The application fee will not be refunded. Applicants are not able to appeal this decision under section 60 of the Act.

If you reapply to list the medicine on the ARTG, ensure your application meets the requirements for an effective application.

You cannot lawfully import, supply or export the medicine until you have an ARTG listing.

9.3.3 Lapsing applications

The application will lapse if evaluation fees are not paid within 28 days of becoming payable. The TGA will notify the applicant of the lapsing of the application. A new application must be submitted, and a new application fee paid, if the applicant wishes to list the medicine.

9.4 Evaluation and requests for information

Once an application has passed preliminary assessment and the evaluation fee has been paid, it enters the evaluation phase. During this phase, the TGA assesses the application, reviews any responses to requests for information, and documents the findings.

9.4.1 Evaluation

The TGA assesses the efficacy data to determine whether it supports the indication(s)/claim(s); and the product label. The assessment includes:

  • a review of the types, quantity, quality and validity of studies;
  • a detailed evaluation of the proposed indication(s) and claim(s);
  • assessment of the medicine presentation for compliance with the various legislative requirements (including labelling and advertising requirements).

9.4.2 Requests for information (RFIs)

The TGA may make a request under section 31 of the Act for additional information to clarify or address issues identified during evaluation. During this time, the evaluation clock will stop. However, evaluators may also seek clarification of minor issues on an informal basis. The clock will not stop in these circumstances.

The applicant should provide an electronic copy of the requested information. No additional unsolicited data will be accepted.

Applicants will be notified of the timeframe for the response. It is important that applicants respond to an RFI within the timeframe provided. If the response is not received within the timeframe specified, or if the issues identified in the RFI remain unaddressed, the application will proceed to the decision phase without the additional information. This may result in the rejection of the application.

Although the TGA may grant extensions to the RFI due date, this will only be done at the discretion of the delegate if the request is received well before the due date, and if the applicant provides a reasonable justification as to why the extension is necessary.

The time between the RFI being issued and receipt by the TGA of the applicant's response will not be counted as part of the evaluation timeframe (i.e. the 'evaluation clock' will stop).

9.4.3 Expert advisory committee advice

The TGA may decide to seek advice from an expert advisory committee, such as the Advisory Committee for Complementary Medicines (ACCM). The TGA will notify applicants of the date of the committee meeting and provide an opportunity for a submission for the committee's consideration. Any advice received from the committee will be communicated to the applicant.

9.5 The decision

When making the decision under section 26AE of the Act on whether to list the medicine in the ARTG, the decision maker (the delegate of the Secretary of the Department of Health) will review all documentation associated with the application, including the dossier, evaluation reports, responses to requests for information, and advice from expert advisory committees.

9.5.1 Decision to list the medicine

If the delegate considers the efficacy of the medicine to have been established and makes a decision to approve the listing of the medicine, the TGA will notify the applicant in writing of the decision.

The decision letter will outline standard and specific conditions on the listing of the medicine under section 28 of the Act. It is important that applicants read, understand and comply with these conditions. If the sponsor does not comply with any one of these conditions of listing, the medicine may be cancelled from the ARTG.

The decision letter will request that the sponsor provides assurance that all details of the medicine are correct before the ARTG entry is created.

9.5.2 Decision not to list the medicine

If the decision is not to list the medicine, the decision letter will include a statement of the reasons for the decision and information on the applicant's rights to seek a review of the decision. Applicants are able to appeal this decision under section 60 of the Act.

9.6 Finalisation

9.6.1 Patent certification under the Australia / USA free trade agreement

Sponsors need to provide a patent certificate under subsection 26B(1) of the Act, or notification that this is not required before the medicine can be listed in the ARTG.

If this was not provided with the application, one of the following documents should be completed and submitted via email to complementary.medicines@health.gov.au, quoting the submission number:

9.6.2 Listing the medicine

Once the completed and signed notification form or patent certificate has been received, the TGA will list the medicine in the ARTG and the product will receive a unique AUST L(A) number.

Sponsors are able to download the certificate of listing from Business Services. To do this, follow the guidance on printing an ARTG certificate. The listing of the medicine will commence on the day specified in the certificate of listing. The medicine cannot be lawfully imported, exported or supplied by the applicant prior to this date.

The product details will usually be viewable on the TGA Business Services website the day after the information has been recorded in the ARTG.

9.7 Post-listing

9.7.1 Publication of outcomes

The TGA may choose to publish a notification of the approval of the medicine on the TGA website. This notification may include the name of the medicine, the sponsor, the approved indications, and any other supporting information necessary. No confidential information (e.g. trade secrets) will be published.

Notices of restricted representations approved under section 42DF and 42DK of the Act are published on the TGA website.

9.7.2 Annual charges

Annual charges will apply to all medicines included in the ARTG.

The charge is applied on an annual basis (in July of each year for existing entries in the ARTG) or upon listing of the goods in the ARTG during a financial year). The annual charges apply to any product in the ARTG at any time during a financial year, regardless of whether the product is subsequently cancelled within the same financial year.

Any new product entering the ARTG will qualify for an annual charge exemption (ACE) until such time as the product generates turnover (refer to Annual Charge Exemption Scheme).

9.7.3 Post-market compliance

Assessed listed medicines, like all listed medicines, may be selected for a post-market compliance review at any time. The TGA will check the assessed listed medicine's compliance against the regulatory requirements that are self-certified by the sponsor. Efficacy of the product will not be routinely reviewed post-market.

For more information refer to Listed medicine compliance reviews.

Assessed listed medicines must also comply with any standard and specific conditions applying to listed therapeutic goods under Section 28 of the Act.

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