In Australia, the regulatory agency responsible for non-prescription medicines is the Therapeutic Goods Administration (TGA). The TGA is a division of the Australian Government's Department of Health and Aged Care and oversees the regulation of all therapeutic goods, including non-prescription medicines.
In the context of the Therapeutic Goods Administration (TGA), Australia's regulatory authority for therapeutic goods, non-prescription medicine comprises of complementary medicines and over-the-counter medicines which includes the following types of medicines categorised based on the ingredients they contain and therapeutic indications:
Listed medicines
Assessed listed medicines
Registered complementary medicines
Over-the-counter (OTC) medicines.
These are specific classifications for medicines based on their level of regulation, safety, and efficacy.
TGA Classification of Non-Prescription Medicines
The Therapeutic Goods Administration (TGA) in Australia classifies non-prescription medicines into several categories based on their level of regulation and safety. Here's an overview of the classifications:
Over-the-counter (OTC) medicines: These are medicines that can be obtained without a prescription are called over-the-counter (OTC) medicines. They are available for general sale to the public, either through pharmacies or, in some cases, supermarkets.
Examples: Pain relievers (like paracetamol), cough syrups, vitamins, etc.
OTC medicines have five risk levels for applications for new medicines (levels N1 to N5) and five risk levels for applications to make changes to existing medicines (levels CN to C4)
Listed Medicines: These are considered low-risk medicines, which include many complementary medicines (like herbal products, vitamins, and minerals).
Examples: Vitamin supplements, herbal remedies, and some non-prescription skincare products.
Unlike Over-the-Counter (OTC) medicines, which are often categorized based on their risk and usage, listed medicines do not have specific subcategories
Registered Medicines: These medicines are considered higher-risk and include both prescription and non-prescription medicines that may have a more significant impact on health.
Examples: Prescription drugs like antibiotics, vaccines, and certain high-dose pain relievers, as well as some over-the-counter medicines like stronger painkillers.
Registered medicine applications are categorised further as RCM 1 to RCM 5 according to complexity.
Assessed listed medicines: These medicines are a newer category (introduced in 2018) and are a step up in regulation compared to regular listed medicines. They sit between fully registered medicines (higher risk, higher scrutiny) and standard listed medicines (lower risk). These medicines are required to have evidence to support their health claims and undergo a more rigorous assessment process by the TGA than regular listed medicines. Assessed listed medicines can be applied under three categories namely: L(A)1 - L(A)3 based on the complexity of the medicine.
Examples: Vitamin C supplements, Calcium tablets, Herbal Medicines, Probiotics.
Differences Between Various TGA Categories of Non-Prescription Medicines
TGA Regulatory Pathway for Non-Prescription Medicines
TGA Regulatory Pathway for Listed Medicines (AUST L): The regulatory pathway is simplified compared to registered medicines. Key Steps in the Regulatory Pathway:
Eligibility: Only medicines containing pre-approved, low-risk ingredients can be listed.
Listing Application: The sponsor (manufacturer or supplier) submits an application through the Electronic Listing Facility (ELF). The sponsor must certify that the product meets the safety, quality, and labeling standards.
Self-Certification: The sponsor self-certifies compliance with the TGA's standards (no pre-market evaluation of efficacy is required).
Inclusion in ARTG: Once approved, the medicine is included in the Australian Register of Therapeutic Goods (ARTG) with an AUST L number, which can be seen on the product label.
Post-Market Monitoring: The TGA conducts random post-market surveillance and testing to ensure ongoing compliance with quality and safety standards.
Claims: No claims about serious diseases or conditions can be made.
Labeling: Must meet TGA’s labeling requirements (including ingredient lists and health claims within specified limits).
Example: A vitamin supplement is eligible for listing if it contains only pre-approved ingredients and meets the labeling and GMP (Good Manufacturing Practice) requirements.
TGA Regulatory Pathway for Assessed Listed Medicine (AUST L(A)): Sponsors must provide clinical or scientific evidence that supports the specific health claims made by the product. Health claims must align with or expand upon the TGA’s Permitted Indications list, and all claims must be supported by evidence. Key Steps in the Regulatory Pathway:
Eligibility: Low-risk medicine with specific health claims that require pre-market evidence assessment.
Submission of Evidence: Sponsors must submit clinical or scientific evidence supporting the health claims.
TGA Pre-Market Assessment: The TGA reviews the submitted evidence to verify the efficacy of the claims.
ARTG Listing: Upon successful assessment, the product is listed in the ARTG with an AUST L(A) number, indicating pre-market assessment of efficacy.
Post-Market Monitoring: Assessed listed medicines are subject to post-market surveillance to ensure ongoing compliance.
TGA Regulatory Pathway for Registered Medicines (AUST R): Due to higher risk, efficacy must be demonstrated through clinical data and these medicines undergo a thorough review process.Key Steps in the Regulatory Pathway:
Pre-Submission Planning: The sponsor works with the TGA to determine the specific requirements for the medicine’s registration.
Application Dossier: The sponsor must submit a comprehensive application, including clinical trial data, manufacturing information, safety, quality, and efficacy evidence.
Evaluation: The TGA conducts a full evaluation of the medicine’s safety, quality, and efficacy. This includes an assessment of the benefits and risks of the product based on clinical data.
Inclusion in ARTG: If the evaluation is successful, the medicine is included in the ARTG with an AUST R number, indicating it is a registered medicine.
Post-Market Monitoring: Registered medicines are subject to continuous post-market surveillance, including adverse event reporting and product testing.
Example: An antibiotic requires registration as it is considered higher-risk, and clinical trials must demonstrate its safety and efficacy for treating bacterial infections.
TGA Regulatory Pathway for OTC Medicines : Non-prescription medicines, like those available OTC (e.g., pain relievers), can fall into either the listed or registered category depending on the risk and ingredients. The regulatory pathway is similar to listed or registered medicines.
If Listed (AUST L): Follow the Listed Medicines pathway as outlined above.
If Registered (AUST R): Follow the Registered Medicines pathway as outlined above.
TGA Labeling Requirements for Non-Prescription Medicines (AUST R, AUST L, and AUST L(A)):
AUST R, L or L(A) Number: The label must display the AUST R, L or L(A) number depending upon the type of Non-Prescription Medicines, indicating that the product has undergone an efficacy assessment by the TGA and is listed on the ARTG.
Dosage Instructions: The label must provide dosage instructions for safe and effective use.
Indications and Claims: Efficacy claims that have been assessed and approved by the TGA can be made (except for listed medicine)
Warnings and Precautions: Any specific warnings, contraindications, or precautions must be clearly stated on the label.
Batch Number and Expiry Date: The packaging must include the batch number and expiry date.
Manufacturer or Sponsor Details: The name and address of the manufacturer or sponsor must be listed.
Storage Instructions: Instructions on proper storage conditions must be provided.
General Labeling Rules for All Categories:
Legibility: Labels must be easy to read, with sufficient contrast between the text and background.
Language: The information must be in English, although multilingual labeling is permitted if the English text is prominent.
Advertising Code Compliance: The labels must comply with the Therapeutic Goods Advertising Code, ensuring that claims are truthful, not misleading, and do not exaggerate the benefits of the product.
TGA GMP Requirements for Non-Prescription Medicines
Regardless of the category, the following GMP elements are required for all medicines regulated by the TGA
Manufacturing Facility Approval: All manufacturers must have their facilities approved by the TGA through regular inspections.
Quality Assurance Systems: Every product must have a comprehensive quality management system to ensure safety, efficacy, and consistency in production.
Traceability and Documentation: Each step of production, from raw materials to finished product, must be documented for traceability.
Staff Training: Personnel involved in manufacturing must be appropriately trained and qualified.
Complaint Handling and Recalls: There must be systems in place for handling complaints and recalling products if quality or safety issues are identified.
Differences in TGA Requirements on Good Manufacturing Practices (GMP) for Non-Prescription Medicines
AUST R medicines | AUST L and AUST L(A) medicines |
These products face more stringent GMP requirements, including more frequent TGA inspections, detailed quality control for complex formulations, and extensive documentation due to their higher risk profile. | Although these lower-risk products follow similar GMP standards, the requirements are slightly less stringent due to the simpler formulations and the use of natural or low-risk ingredients. |
In conclusion, the Therapeutic Goods Administration (TGA) plays a critical role in ensuring the safety, quality, and efficacy of non-prescription medicines in Australia through a structured regulatory framework. The TGA's oversight of advertising also helps protect consumers from misleading claims. Overall, the TGA ensures that non-prescription medicines on the Australian market are safe for consumer use and provide the health benefits they claim, contributing to public health and safety.
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