The TGA has published a new consultation on their Consultation Hub ‘Reforming Australia's Therapeutic Goods Testing Regulations’, closing 5 August, outlining a number of legislative reforms to Part 5 of the Therapeutic Goods Regulations 1990 that sets out procedures enabling the examination, testing and analysis of goods conducted by the TGA Laboratories.
Part 5 has undergone minimal reform since enactment in 1990. The reforms are largely seeking to increase powers of testing of unapproved (illegal) goods, counterfeit goods, etc, however there are some changes that are relevant to sponsors, manufacturers and wholesalers of legal goods including entering premises and how the results of testing are handled.
The TGA are seeking feedback on 8 proposals to determine whether the changes are fit for purpose to increase protections without increasing unnecessary compliance burdens. CMA has provided a brief overview of each below. Please refer to this full Tech alert for more context and details.
Proposals that may be more likely to affect sponsors and manufacturers of complementary medicines on the ARTG compared to existing arrangements, where CMA is seeking further member feedback:
Proposal 2 – Revise the powers of an authorised officer
Currently, authorised TGA officers can enter premises to obtain samples from licence holders, manufacturers for whom a conformity assessment certificate has been issued, wholesalers and, in some cases, sponsors. The TGA are proposing to expand this to all sponsors (including sponsors of unapproved goods), all manufacturers including those that are exempt or manufacture exempt goods, and wholesalers.
Proposal 4 – Improve clarity and definitions
Proposes to update and remove some definitions to reduce confusion created by inconsistent wording and unclear definitions. Although this appears supportable, newly proposed definitions have not been provided in the consultation paper in full for stakeholders to consider the impact.
Proposal 5a –Simplify information in certificate of responsible analyst
Analysts would no longer be required to decide whether a relevant good complies with applicable requirements, rather, the certificate would be limited to factual matters about the sampling and testing of the goods and the results. The certificate’s information would be used to inform the delegate of the Secretary in the relevant Branch (such as the Complementary Medicines & OTC Branch) about the quality of the sample tested, who would then be responsible for the decision as to whether the good complies with legislative requirements and what level of regulatory action is required.
Proposal 5b – Repeal of the review process in line with proposal 5a
As a certificate under Proposal 5A would no long determine compliance with legislation, the review (appeal) rights would be removed. However, if regulatory action were taken that relied on the certificate (such as a proposal to cancel the goods), the sponsor would have review rights under that action taken. However, CMA identifies that if the action taken is an infringement notice, the only action open to the sponsor is to pay the infringement, request withdrawal, or not pay it – which risks court proceedings.
Proposal 7 – Increasing the reliance on the certificate of responsible analyst
Proposes to expand the scope of legal proceedings under which the testing certificates are relevant, for example legislation other than therapeutic goods law, including common law. To support this the Regulations would also be updated to prescribe what technical and procedural matters of fact must be recorded, and what may be recorded on the certificate.
Proposals that appear less likely to affect sponsors and manufacturers of listed complementary medicines, and/or are more evident to have an overall positive impact for industry. These are likely to be supported by CMA unless further feedback received from members:
Proposal 1: Apply Part 5 to a wider range of testing:
Proposes to increase the scope of samples that can be tested for quality, safety or performance to ‘a good for supply within Australia or for export only’, including where and how samples can be obtained or received. This increased scope would include illegal goods supplied into or entering the country, and help determine whether they are a therapeutic good.
Proposal 3 – Make testing processes clearer and more streamlined
Proposes to remove prescriptive provisions in the Regulations relating to collection, handling, and storage of samples and the roles and responsibilities of analysts are removed, in favour of using internal TGA QMS procedures as supported by the TGA’s NATA and ISO/IEC laboratory qualifications.
Proposal 6 – Amend the requirements for the release of a certificate of responsible analyst
Proposes that the certificate is sent to the sponsor of the goods only where the sponsor is identifiable – which may not always be the case, for example, some unapproved goods. It also proposes that it is no longer required to also be sent to the person from who the sample was taken, but only provided to other parties on a case-by-case basis, to provide the TGA more discretion over whom should appropriately receive the information.
Proposal 8 – Extension of the offence to intimidate authorised officers
Proposes to provide TGA testing analysts protection from influence or intimidation while performing their duties.
Please read today’s full tech alert, which provides information for members, including a summary of TGA proposals and how to respond to the consultation.
