The TGA has finalised the outcomes of the Lower Risk Registered OTC Products Review Pilot Project.
On this page: Background | Review of Active ingredients | Indication review | Project outcomes and options for sponsors | Further information
Background
A Lower Risk OTC Products Review pilot project was developed in response to recommendation 14 of the Medicines and Medical Device Regulation Review (MMDR) where the TGA examined whether the regulations and restrictions in place for various low-risk registered therapeutic goods are still appropriate. This recommendation related to several different types of therapeutic goods, including registered OTC medicines.
The TGA undertook to review classes of registered OTC medicines, that have a higher amount of regulation applied to them, to assess whether they may be suitable for becoming listed medicines (listed medicines have less strict regulatory guidelines applied to them). Consultation with peak industry bodies was performed to review whether any classes of registered OTC medicines might be suitable for regulation as listed medicines. A pilot project was proposed to provide further clarity on the resource requirements, limitations and impacts on medicine sponsors as well as to address additional issues raised by industry during the consultation.
Pilot project
The pilot project was designed to review both the active ingredients and associated indications for a particular group of registered OTC medicines to determine if this medicine group could be down-regulated to listed medicine framework.
'Antimicrobial throat lozenges' were identified as the medicine group to be considered for the pilot project, due to their long history of use, the presumed likelihood that the active ingredients would be suitable for use in listed medicines and the limited number of indications associated with this group.
Below are the results of the TGA review the active ingredients and indications of this medicine group to determine their appropriateness to be down-regulated to the listed medicine framework.
Review of Active ingredients
Five active ingredients commonly used by antimicrobial throat lozenge products were identified for evaluation as part of the pilot project. These were:
- Amylmetacresol
- Benzyl Alcohol
- Cetylpyridinium Chloride
- Dichlorobenzyl Alcohol
- Hexylresorcinol
All five of the active ingredients were supported by quality monographs in the British Pharmacopeia (BP). A safety evaluation was conducted using publicly available data. This considered whether each ingredient's safety profile including their dosage, directions for use and target population were suitable for use in listed medicines. The review also considered restrictions placed on existing OTC medicine group.
In summary, based on the ingredient assessments:
- Three of the ingredients were considered suitable for use as active ingredients in listed medicines. These were benzyl alcohol, cetylpyridinium chloride and hexylresorcinol, however they would require specific restrictions regarding duration of use, maximum daily dose and label warnings regarding use in pregnant or lactating women.
- Two ingredients, amylmetacresol and dichlorobenzyl alcohol, had insufficient information available to establish safety of use and were therefore considered unsuitable for use as active ingredients in listed medicines.
The ingredients suitable for listing were included in the Therapeutic Goods (Permissible Ingredients) Determination (No.4) 2019 (Permitted Ingredients Determination or 26BB).
Indication review
The TGA also reviewed the indications currently in use by existing OTC medicine group against the criteria for permitted indications in subsection 26BJ of the Therapeutic Goods Act 1989 and the permitted indications assessment tool available on the TGA website.
The indications currently in use by existing OTC medicine group captured by the pilot project were compared against the indications available in the Therapeutic Goods (Permissible Indications) Determination (No.2) 2019 (Permissible Indications Determination). The medicine group was associated with a total of 12 unique combinations of indications which can be broadly summarised as 'temporary relief from the symptoms and discomfort of sore throat and minor throat infections'.
The Permissible Indications Determination includes 15 indications that could be considered similar in intent to many indications currently being used by registered OTC throat lozenges, for example: 'Decrease/reduce/relieve symptoms of mild throat infection'.
However, three common indications used by the existing OTC medicine group were determined to be not suitable for inclusion in the Permissible Indications Determination as they were deemed to be of a higher level (and risk) than what is considered appropriate for use in low risk listed medicines. These were:
- Kills bacteria /antibacterial action
- Antiseptic action
- Anaesthetic action/numbs throat
To be consistent with their low risk status, and the fact that they are not assessed before being marketed, listed medicines may only use low level indications that will not lead to their unsafe or inappropriate use. For example; permitted indications should only refer to a non-serious form of a disease, condition, ailment or defect, i.e. one that is able to be self-diagnosed and/or self-manageable where a delay in medical treatment will not cause harm to the consumer - this excludes indications relating to the treatment or prevention of bacterial infections. Medicines that use higher-level indications undergo assessment before being granted market approval (ie listed assessed or registered medicines).
For a medicine within the existing OTC medicine group to transition to the listed medicine framework, the indications associated with this medicine will need to change to indications that are permissible (ss26BJ).
Project outcomes and options for sponsors
Benzyl alcohol, cetylpyridinium chloride and hexylresorcinol have been included in the Permissible Ingredients Determination for use as active ingredients as of 19 November 2019.
Sponsors have the option to keep their existing OTC medicine's current registration or to cancel their registration and list their medicine on the ARTG noting that the sponsor will need to certify that the medicine meets all other requirements for listed medicines.
Where an existing OTC medicine contains ingredients not included in the Permissible Ingredients Determination, these medicines would need to be reformulated to contain only permitted ingredients.
Where an existing OTC medicine uses indications that are not included in the Permissible Indications Determination, the indications associated with these medicines would need to change to low-risk permissible indications (ss26BJ). Removing reference to antiseptic and/or anaesthetic action and include an appropriately qualified reference to infections such as 'mild' would need to occur in order to transition.
New medicines that are using permissible indications and contain only permitted ingredients can list their medicines in the ARTG. Otherwise, products using higher level indications than what are included in the Permissible Indications Determination can apply through the listed assessed or registered pathway for evaluation.
Given the limited benefits of the outcomes of this pilot project, the uptake of outcomes may be minor, but the TGA will nevertheless review the uptake of these outcomes to inform the future directions of the lower risk OTC products review as a whole.
Further information
For more information please contact Complementary Medicines via phone on 1800 020 653 or via email at complementary.medicines@health.gov.au.