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Assessed listed medicines evidence guidelines
Version 1.1, August 2018
4. Application Categories
Applications for assessed listed medicines are made under section 23B of the Act. There are three categories of application, L(A)1 - L(A)3. The increasing levels correspond to the increasing complexity of applications, and consequently, increasing data requirements, evaluation timeframes and fees.
It is important to ensure that you select the correct application category for your application in order to ensure that it can be accepted for evaluation.
This guidance provides descriptions of the three application categories. If your proposed application does not appear to be captured by a category, you can determine the appropriate application category by considering the data requirements for efficacy, which are outlined in Module 5 of the Common Technical document (CTD) guidance.
4.1 Application category: L(A)1
This category includes products that are identical to an existing assessed listed medicine other than permitted differences, such as its name, colour, printing ink, flavour and/or fragrance.
The following conditions must be met:
- The reference medicine must have been fully evaluated for efficacy by the TGA.
- The reference medicine must comply with all current requirements and standards, relevant Therapeutic Goods Orders (e.g. TGO 77, TGO 78, TGO 80, TGO 92) and default pharmacopoeial standards.
- Label, indications and formulation must reflect the fully evaluated reference medicine.
- Full access by the TGA to the reference medicine dossier must be provided. The sponsor of the reference medicine must authorise the TGA to access the information on the reference medicine files and ARTG record for the purpose of the application.
Table 3 summarises the list of differences that are appropriate for L(A)1 applications.
|Sponsor details||The sponsor of the flavour/fragrance/colour variant can differ from the sponsor of the reference medicine, provided the sponsor of the reference medicine authorises the TGA to access the information on the reference medicine files and ARTG record for the purposes of the application.|
|Medicine name||The proposed medicine name must be different to the reference medicine. The proposed medicine name cannot include a claim/indication that is not approved for inclusion in the ARTG entry or name of the reference medicine. Including a subset of the approved indications in the medicine name is not permitted.|
|Manufacturing sites||The manufacturing sites for the proposed medicine can differ from the reference medicine where the proposed manufacturer has been validated and shown to be equivalent or better. Ensure that you have valid evidence of GMP for the manufacturers.|
Only the flavour, fragrance and/or colour agents can differ in the proposed medicine, and the combined total difference cannot be more than 2% w/w or w/v of the total formulation.
The proposed raw material specifications for new flavour/fragrance/colour must comply with applicable standards, and all components are included in the Therapeutic Goods (Permissible Ingredients) Determination.
If the new flavour/fragrance/colour includes excipients that must be declared on the label, ensure that the labels have been updated accordingly. If the medicine label includes any claims that it does not contain a particular excipient (e.g. gluten free, sugar free, lactose free) ensure the claims are true in regard to the components of the new flavour/fragrance/colour.
|Pack size||The proposed pack size(s) can differ from the reference medicine only for solid dosage forms where there is no change in container material.|
The labels for the proposed medicine must be identical to the reference medicine, other than the medicine name, design and layout, pack size details, sponsor or supplier details and logos.
The proposed label graphics can differ from those approved for the reference medicine provided that:
|Finished product specifications / visual identification||
The finished product specifications must be identical to those approved for the parent medicine other than the flavour/fragrance/colour (including printing inks) aspects.
The visual identification can differ from the reference medicine only when it is either a direct consequence of the new flavour/fragrance/colour agent(s); or a difference in debossing/embossing/printing to remove or add identifying marks.
4.2 Application category: L(A)2
This category is for generic medicines or medicines where a Comparable Overseas Regulator (COR) has demonstrated their efficacy.
In comparison to the fully TGA evaluated assessed listed reference medicine, the proposed generic medicine must have the same:
- active ingredient(s) with same quantity;
- dosage form;
- directions for use;
- indications; and
- safety and efficacy properties.
The generic medicine must:
- be bioequivalent when compared to the reference medicine (meet the Biopharmaceutic and pharmacokinetic requirements; and
- provide a justification of the use of the particular combination of ingredients including potential interactions.
4.2.2 Medicine evaluated by a Comparable Overseas Regulator (COR)
The TGA is currently developing guidance for the use of evaluation reports from CORs. Guidance and a list of accepted CORs will be available on the TGA website in due course.
4.3 Application category: L(A)3
This category includes all products that are not covered by L(A)1 or L(A)2 and is either:
- a new medicine requiring a de novo evaluation of the efficacy of the product.
- a variation to an existing approved assessed listed medicine, where the medicine contains one of the following:
- different active ingredient(s)
- different strength (i.e. quantity of active ingredient(s))
- different indication(s) (other than removing an indication)
- different dosage form; or
- different excipients.
L(A)3 applications must provide complete Module 1, Module 2 and Module 5, as applicable.
To demonstrate efficacy, L(A)3 applications must:
- provide efficacy evidence in line with Table 5 (using Method 1, 2A or 2B)
- meet the evidence requirements specified under Evidence requirements and standards and Alignment of indications and evidence.
4.4 Variations to an existing assessed listed medicine
Once a medicine has been listed in the ARTG, the sponsor may request approval from the TGA to make changes to the application. Subsection 9D(1), 9D(2) and 9D(3) of the Act provides the circumstances under which a sponsor may request an amendment to the ARTG. These include:
- correction of an ARTG entry of a medicine that is incomplete or incorrect;
- certain safety-related variations to an ARTG entry of a medicine that reduce the patient population (such as by removing an indication), or have the effect of adding a warning or precaution (such as an adverse effect or interaction);
- other variations to an ARTG entry of a medicine, provided that the delegate of the Secretary is satisfied that the change does not reduce the quality, safety or efficacy of the medicine.
The TGA is currently developing the variation application types for assessed listed medicines.
4.4.1 Changes to labels
Once a product has been listed in the ARTG, the sponsor may request approval from the TGA to make changes to the label.
New draft labels must be supplied to the TGA with the application. Relevant changes must be highlighted (e.g. through the provision of 'track changes' labels or a table detailing all the proposed changes).
- Sometimes referred to as the 'innovator', 'originator' or 'parent' medicine.