Changes applying to evaluation of new substances for listed medicines

Background

All listed medicines (AUST L listed medicines and AUST L(A) assessed listed medicines) may only contain ingredients included in the Therapeutic Goods (Permissible Ingredients) Determination (‘the Permissible Ingredients Determination’).

For a substance to be permitted for use as an ingredient in listed medicines, an applicant must apply for evaluation of a substance for use in listed medicines. The TGA will evaluate the substance to determine whether it is of appropriate safety and quality to be permitted for use as an ingredient in listed medicines. Once the substance is determined to be safe, it is included in the Permissible Ingredients Determination.

What has changed?

The TGA has introduced Mandatory requirements for applications to vary the Permissible Ingredients Determination under section 26BD of the Therapeutic Goods Act 1989, and accompanying guidelines. These came into effect on 1 February 2023 and only apply to new applications submitted from this date.

These requirements specify what information, and how that information must be provided for an application to pass preliminary assessment and progress to the evaluation phase, consistent with other therapeutic goods application processes. This ensures that applications are accepted for evaluation if they have sufficient information that would be required to undertake a meaningful and efficient evaluation of the safety and quality of the substance to be approved. The requirements have been tailored for different types of substances and routes of administration, whilst continuing to allow justifications to be provided for individual circumstances or approaches not covered in the guidance.

As part of this work, the IN1 new substance application category was also amended through the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 in December 2022. The amendment means IN1 applications (that have reduced fees and or shorter evaluation times) can now be submitted to support safety based on evaluation reports from Comparable Overseas Bodies (COBs) and quality based on a monograph contained in a default standard.

In developing these requirements the TGA has consequentially updated other supporting documents that relate to the evaluation of new substances, including updating the list of COBs for which evaluation reports are accepted for use in abridged evaluation categories. For example, the COB list now permits reports from the European Scientific Committee on Consumer Safety to support safety and quality of excipient and active substances for dermal use as part of IN1, IN2 or IN3 applications. Reports were previously only permitted to support the safety of excipients in an IN1 or IN2 application. The TGA has also developed new guidelines to assist applicants applying for a new microorganism (i.e. probiotics and postbiotics) in listed medicines or registered complementary medicines.

A list of new documents are linked below.

New mandatory requirements and guidelines documents

• Mandatory requirements for an application to vary the Permissible Ingredients Determination
• Application requirements for new substance for use in listed medicines
  Guidance on the application process and information required for a substance to be evaluated for use as a new ingredient in listed medicines.
• Overview of compositional guidelines and templates
  Guidance about compositional guidelines and templates to help develop them for a new substance application.
• Requirements for microorganism characterisation in listed medicines and registered complementary medicines
  Data requirements for applications relating to microorganisms used as active ingredients in listed medicines or registered complementary medicines. These are generally referred to as probiotics or postbiotics.
• Comparable overseas bodies (COBs) for complementary medicines
  Guidance on using assessments from comparable overseas bodies in evaluations for complementary medicines and listed medicines.
• A new list of approved COBs and updated COB checklists.

Further information

If you have any further questions, please contact Complementary Medicines via phone on 1800 020 653 or via email at complementary.medicines@health.gov.au.