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Assessed listed medicines evidence guidelines
Version 1.1, August 2018
2. Eligibility and regulatory requirements
In order for applicants to utilise the assessed listed medicines pathway, the proposed product must meet all the safety and quality requirements for listed medicines. Additionally, assessed listed medicines must meet specific requirements relating to efficacy, presentation and supporting evidence.
Applicants must certify that the proposed product meets the requirements of subsection 26AB(2) of the Therapeutic Goods Act 1989 (the Act), and if applicable, subsection 26AB(3). Part B of the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provides detailed information on the safety, quality and efficacy statutory requirements and conditions for listed medicines. The ARGCM will be updated to include the requirements and conditions for assessed listed medicines. In the meantime, applicants may refer to the requirements for listed medicines in Part B of ARGCM for general information; the requirements for assessed listed complementary medicines are similar, except with respect to the pre-market assessment of the efficacy evidence by the TGA.
Key elements of the assessed listed requirements are summarised below.
2.1 General requirements
Medicines listed via the assessed listed medicines pathway must:
- contain only permitted ingredients that have been evaluated for safety and quality, and meet the requirements associated with their use in listed medicines. These ingredients and their associated requirements are specified in the Therapeutic Goods (Permissible Ingredients) Determination;
- not contain ingredients included in a schedule to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP);
- not be required to be sterile. Consistent with the current listing framework, a medicine that is required to be sterile cannot be listed via the AUST L(A) pathway (see Schedule 4 of the Therapeutic Goods Regulations 1990);
- not be a prohibited import for the purposes of the Customs Act 1901;
- meet all specifications for the shelf life of the medicine, the recommended storage conditions and the expiry date stated on the product label;
- comply with all applicable standards and legislative requirements in relation to quality and safety of medicines;
- not be an export only medicine; and
- not be a medicine that has previously had its registration or listing cancelled.
The sponsor must self-assess and certify under subsection 26AB(2) of the Act that the medicine meets the above requirements. These aspects of the medicine are not pre-market assessed by the TGA, but may be subsequently reviewed during standard post-market compliance processes. If the medicine exceeds some of the above requirements (e.g. ingredients not in the Permissible Ingredients determination), then it may be suitable for the registered pathway.
2.2 Evidence of GMP
Assessed listed medicines must be produced in accordance with the PIC/S Guide to GMP (see Manufacturing principles for medicinal products.
Applicants must provide valid evidence that the manufacturer(s) of the product have applied GMP for each step of manufacture. This evidence is:
- a copy of a GMP licence issued by the TGA (for Australian manufacturers)
- a GMP clearance issued by the TGA (for overseas manufacturers)
Applicants must also ensure that the GMP clearance remains valid for the entire duration of the evaluation from the date of submission. The target timeframes vary for different application categories. 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.
2.3 Indications and presentation
To be eligible for the assessed listed medicine pathway, the proposed product:
- must carry one or more intermediate level indication(s) (an indication that exceeds the list of permitted indications but is not a high level indication; see Indications). Products that carry intermediate level indications, including product-based restricted representations and certain indications referring to biomarkers, must go through the assessed listed medicines or registered complementary medicines pathway;
- must carry the intermediate indication(s) on the product label;
- may carry optional additional low level indications which meet the criteria for a low level indication (for example, a permitted indication). Evidence to support these low level indications must also be supplied and pre-market assessed by the TGA;
- must not carry any reference to a prohibited representation;
- must carry all required label advisory statements, restrictions on dosage and restrictions on route of administration;
- must not have an unacceptable presentation, as specified in the subsection 3(5) of the Act and 3(A) of the Regulations;
- must have a label assessed and approved by the TGA, and which meets the requirements of Therapeutic Goods Order No. 69 - General requirements for labels for medicines OR Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO92); and
- must conform to every requirement relating to advertising specified in Part 5-1 of the Act and the Therapeutics Goods Advertising Code.
The indications and presentation of the product will be pre-market assessed by the TGA. The only indications that can be used on the label are those that are assessed by the TGA and included in the ARTG entry.
Sponsors must ensure that the information contained in the application is correct. An incorrect certification could result in the product being cancelled from the ARTG under the provisions of paragraph 30(2)(bab) of the Act.
- The Therapeutic Goods Act 1989 defines label as a display of printed information; on or attached to the goods, container or primary pack; or supplied with the container or pack.