New TGA consultation: Reforming Australia’s Therapeutic Goods Testing Regulations 

A new public consultation has been published on Reforming Australia’s Therapeutic Goods Testing Regulations, closing 5 August. This consultation outlines a number of legislative reforms the TGA are proposing to strengthen and modernise the legislative framework through improving the clarity and functionality of the arrangements in Part 5 of the Therapeutic Goods Regulations 1990 (the Regulations), which sets out procedures for examination, testing and analysis of goods to be conducted within the regulatory framework. 

Currently, Part 5 of the Regulations is applicable to only a subset of the TGA’s sampling and testing activities. The TGA has conducted a review of Part 5 of the Regulations to determine its suitability. The TGA’s review of Part 5 showed that there are gaps in the current legislative and regulatory framework for sampling and testing, and concluded that Part 5 does not currently meet the criteria set out in the Health Regulatory Policy Framework (HRPF).  

The TGA are now seeking stakeholder input on proposals that aim to align Part 5 with the HRPF and enhance the Regulations to protect the health and safety of Australians, while minimising unnecessary compliance burden, i.e. to ensure Part 5: 

  • is fit for purpose (i.e., is well designed for its intended outcomes); 
  • takes into account the latest innovations; 
  • is efficient to comply with and administer; 
  • is effective in achieving its outcomes; and 
  • is fair, transparent, and resilient. 

The Consultation  

The problems and associated proposals outlined in the consultation paper are intended to provide all stakeholders with increased transparency and confidence in the TGA Laboratory testing program, while allowing greater flexibility and responsiveness of the testing framework.  

The four identified problems and a summary of associated TGA proposals are summarised below and a summary of consultation questions is provided in the consultation paper. Members are encouraged to read the full consultation paper for all details and information.  

Members can respond to the consultation directly via the online survey by 5 August and/or provide any feedback to CMA via technical@cmaustralia.org.au by 29 July 2024

Problem 1. Limited application of the testing framework 

Proposal 1 – Apply Part 5 to a wider range of testing 

The TGA has identified the testing framework as no longer being fit for purpose as it does not adequately align with the expanded scope of the therapeutic industry, or provide coverage for emerging innovations. The TGA are seeking to broaden the application of the testing framework to increase the scope of samples that can be tested under the framework, as well as where and how samples can be obtained, or received for testing. The TGA are proposing to expand testing under Part 5 to include all testing to assess the quality, safety or performance of a good for supply within Australia (including imported goods) or for export only. Testing would cover all aspects of the testing activities undertaken, including examination, analysis, evaluation and observation. The TGA provide examples for vaping products with nicotine, counterfeit products including semaglutide, and unmarked goods including botanical substances such as Traditional Chinese Medicine herbal products, where laboratory testing can confirm the presence or absence of aristolochic acids. 

The TGA also propose that the testing framework in the Regulations would cover testing of goods to determine whether the goods are therapeutic goods, for example, the testing of samples provided by law enforcement agencies like Australian Border Force (ABF) that are often not registered on the ARTG. Because this testing is performed on unregistered goods, the testing does not fall under Part 5.  

Currently, Part 5 only applies in relation to samples that are: 

  • taken by an authorised officer under regulation 24 of the Regulations; or 
  • delivered by a sponsor in compliance with a condition of the entry of the relevant good in the Register (namely, under paragraph 28(5)(h) or subsection 41FN(2) of the Act). 

There are no anticipated changes to increase regulatory burden on stakeholders or sponsors of products listed on the ARTG, as the TGA’s laboratory testing program already covers testing of these samples. 

Proposal 2 – Revise the powers of an authorised officer 

The TGA are seeking inclusion of these powers for sponsors of unapproved goods will assist in enforcement activities once the products are tested under Part 5. 

Currently, under regulation 24 of the Regulations, an Authorised officer is only permitted to exercise powers and perform duties relating to entering certain premises, inspecting the place at which goods are kept, taking samples of those goods and ask for information relevant to the manufacture and testing of those goods. 

This means that, if a sample of a therapeutic good is taken from any other premises, that sample would be tested outside Part 5 of the Regulations e.g., most samples of unapproved goods provided by State and Territory Health Departments, and law enforcement agencies (such as Australian Border Force or Australian Federal Police), as well as those provided by hospitals, pharmacies, etc. The TGA are proposing that authorised officers be empowered to enter the premises of: 

  • all sponsors, including the sponsors of unapproved therapeutic goods; 
  • all manufacturers, including those who manufacture goods that are exempt (or who are themselves the subject of an exemption) from the operation of Part 3-3 of the Act; and 
  • wholesalers. 

Problem 2. Prescriptive processes that are inflexible, unclear and burdensome 

Part 5 has many regulations that are overly prescriptive and no longer align with modern best laboratory and regulatory practice. This will hinder future progression and innovation. There is also a lack of clarity stemming from unclear processes with gaps or duplicative information. This creates difficulties and inconsistencies for interpretation, compliance and administration. The TGA are seeking to clarify and streamline processes and definitions. 

Proposal 3 – Make testing processes clearer and more streamlined 

The TGA are proposing to facilitate clearer, more flexible, and efficient processes and arrangements for sampling and testing activities and: 

  • propose that the prescriptive processes dealing with the collection, handling, and storage of samples of therapeutic goods be removed from Part 5.  
  • propose that the unnecessary demarcation, such as for the roles and responsibilities of analysts, responsible analysts and official analysts be removed from Part 5; and 
  • propose that these procedures should be conducted according to, and supported by, comprehensive internal Quality Management System (QMS) procedures, rather than existing within the Regulations.  

The TGA Laboratories maintain accreditation with the National Association of Testing Authorities (NATA) to ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories. This international standard defines requirements to ensure laboratories operate competently and generate valid results. 

The TGA state that removing the sample handling and process requirements from the Regulations will allow flexibility for technical and administrative processes which is vital to ensuring that they can keep pace with the development of novel therapeutic goods and updated testing methodologies and changing Australian and international standards.  

Proposal 4 – Improve clarity and definitions 

The consultation states that there is currently an overarching lack of clarity within Part 5 that is principally due to the use of vague and ambiguous language in several provisions. For example, the use of undefined, but overlapping words like ‘examination’, ‘testing’ and ‘analysis’ causes confusion and uncertainty when attempting to understand the regulatory process.  The TGA are proposing to update the definitions to reduce confusion created by inconsistent wording and unclear definitions.  

These updates are stated to ensure that words are clearly defined if required beyond their ordinary meaning and ensure that the application of these words throughout the Regulations remains consistent. The TGA: 

  • propose that the meaning of ‘testing’ be clarified to include all testing activities including examination, analysis, evaluation, observation, etc.; 
  • propose that unnecessary definitions be removed, including the duplicative roles of ‘analysts’, ‘official analysts’ and ‘responsible analysts’, which are proposed to be streamlined to a single role for ‘analysts’. This definition would also include clarification that different analysts may be responsible for performing tests on a single sample; and 
  • propose to review the reference to terms like ‘laboratories’ to ensure consistency of application throughout Part 5. 

Although this appears supportable, newly proposed definitions have not been provided in the consultation paper in full for stakeholders to consider the impact. 

Problem 3. Complex and inefficient procedures regarding the evidentiary certificate. 

There are multiple complex procedures in Part 5 for the production and use of the evidentiary certificate. These procedures are convoluted and often duplicative of other areas of the legislative framework. There are multiple processes and procedures that can be improved to decrease ambiguity and increase fairness and transparency. The TGA are seeking to amend procedures for the requirements, release of information and reliance on evidentiary certificates. 

Proposal 5a –Simplify information in certificate of responsible analyst 

The TGA are proposing that analysts would not be required to decide whether a relevant good complies with applicable requirements. Instead, it is proposed that the information to be included in the certificate would be limited to factual matters about the sampling and testing of the goods, as well as the results of that testing. The information contained within the certificate would be used to inform the delegate of the Secretary about the quality of the sample tested. The delegate of the Secretary would then be responsible for the decision as to whether the relevant good complies with the applicable legislative requirements.   

The TGA state that they consider it to be more appropriate for a certificate to only state information related directly to the sampling and testing of the goods as well as the results of that testing, noting that testing samples, the TGA often test for compliance with labelling requirements (e.g., compliance with Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines). If an issue is detected with the labelling, then a certificate must be issued stating that the product is non-compliant.  

By removing this decision, the TGA can instead inform the delegate of the Secretary about the results of our analysis who may then use their discretion to determine what level of regulatory action needs to be taken. The TGA also not that this process also reflects what occurs in practice: the results of testing are provided to other areas of the TGA and the Department to use as a signal, to investigate further, or to take enforcement or other regulatory action. 

Proposal 5b – Repeal of the review process in line with proposal 5a 

Currently, if a certificate has been issued to indicate a product is not compliant with a relevant requirement about quality, safety, efficacy or performance, the certificate must include a statement to say that the recipient of the certificate may ask, under regulation 30, for the results of analysis to be reviewed.  

In line with proposal 5a, regulation 30 review process would also be removed from Part 5 as it will no longer be necessary as no significant regulatory decision is made in the certificate. The TGA state that analysis of stakeholder feedback and requests for guidance indicate that regulation 30 is difficult to understand and navigate and that its removal would make the review process straightforward and familiar, without removing the right to review for any subsequent regulatory decision. If an impacted stakeholder has concerns about the validity of the results informing the regulatory decision, they may still provide the decision maker with evidence that the relevant goods are compliant and request that the TGA Laboratories’ results be reviewed. 

However, CMA identifies that if the only subsequent regulatory action is in the form of an infringement notice, the sponsor does not have usual Sectio 60 appeal rights. Rather, the action open to the sponsor is to pay the infringement, request withdrawal, or not pay it if the sponsor believes it isn’t valid – which risks court proceedings. 

Proposal 6 – Amend the requirements for the release of a certificate of responsible analyst 

Currently, subregulation 29(2) specifies that the TGA must send a copy of the certificate to:  

a) The sponsor of the goods, and  

b) if the sample was taken under the powers of an authorised officer, and the person from whom the sample was taken is not the sponsor of the goods – the person from whom the sample was taken. 

The TGA are proposing that: 

  • regulation 29 be updated to ensure that it is mandatory for an analyst to send a copy of the certificate to the sponsor where the sponsor is identifiable. The proposed increased scope of testing, particularly to cover compliance testing, will mean that a sponsor is not always identifiable when goods are seized unpackaged or unmarked.  
  • provision of the certificate to any other party will be on a case-by-case basis. If it is necessary to provide information to another party, this could be done using the existing mechanisms under section 61 of the Act for release of therapeutic goods information in certain circumstances. This proposal recognises that release of information to a person other than the sponsor is not always appropriate and requires more discretion than is currently provided within Part 5.    

The TGA state that there will be no impact to the supply of a certificate to the sponsor. This subregulation will remain mandatory for an analyst to comply with, but allows for instances where compliance is impossible due to the condition of the goods as received or seized. This proposal serves only to bring the subregulation in line with any updates to Part 5 that increase the scope of testing. 

Proposal 7 – Increasing the reliance on the certificate of responsible analyst 

Due to the wording used within subregulation 29(5) the use of testing certificates is limited to only proceedings under the Act or the Regulations; “In proceedings under the Act or these Regulations, [this certificate is], in the absence of evidence to the contrary, conclusive proof of the matters set out or stated in it.”,. However, there are a range of legal proceedings that may be commenced under other legislation or the common law to which the results of TGA Laboratories test results are also relevant. Currently, the certificate would not necessarily hold the same evidentiary value.  

The TGA are proposing to amend the wording so that a certificate produced would hold the same evidentiary value in all Court or Tribunal proceedings. To support this, the TGA also propose that the Regulations prescribe, with greater specificity, the information that an analyst must, and as appropriate, may record in the certificate. These matters would be limited to technical and procedural matters of fact that are relevant to the testing of a sample, such as the tests performed, results of testing and any information relevant to the testing. 

The TGA provide that the changes proposed to the use of the certificate of results will provide additional consistency and transparency in regulatory actions and Court or Tribunal proceedings for which the certificate is presented as evidence; and is also bolstered by the additional clarity that will be provided for in the Regulations regarding the contents of the certificate.   

Problem 4. Insufficient protection for staff while performing their duties 

The regulations in place to protect staff while performing their duties have a narrow scope of application which has exposed staff to inappropriate behaviour. The TGA are seeking to expand the provision for offences relating to intimidation of staff members in the conduct of their duties. 

Proposal 8 – Extension of the offence to intimidate authorised officers 

Currently, subregulation 32(1)(a) is in place to protect an authorised officer as they execute their powers or perform their functions under the Regulations. This regulation makes it an offence to molest, obstruct, or try to intimidate or influence an authorised officer. The penalty for such activity is 10 penalty units (currently equal to $3,130).  

This subregulation is critical to ensure protection from inappropriate behaviour and should remain in place. However, despite the protection afforded to authorised officers, analysts are not afforded the same protection and have been the subject of inappropriate behaviour intended to intimidate or influence. The TGA are proposing that the same protection provided to authorised officers should also be extended to analysts who are exercising their powers or performing their duties under the Regulations. The TGA propose to apply the same number of penalty units for offences against authorised officers and analysts (10 penalty units). 

The TGA consider that an extension of this subregulation to cover analysts is a suitable way to minimise the risk of analysts being exposed to intimidation and harmful behaviour. Extension of the current offence to analysts will also allow the work of analysts to continue in an objective and uninhibited manner. This ensures that all laboratory testing results are a fair and accurate representation of laboratory testing.  

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