The Therapeutic Goods Administration is seeking industry feedback on potential reforms to Part 5 of the Therapeutic Goods Regulation (the Regulations) 1990 to develop a modernised framework.
Part 5 of the Regulations sets out procedures for the examination, testing and analysis of goods to be conducted under the TGA’s regulatory framework. Currently, this Part is applicable to only a subset of the regulators sampling and testing activities.
In line with the Department of Health & Aged Care’s Health Regulatory Policy Framework (HRPF), the TGA is conducting a review of the Regulations to determine the suitability of Part 5. Feedback is being sought from industry on proposed changes to the Regulations, to ensure the exercise effectively balances consumer safety without imposing unnecessary burden on industry.
The TGA has considered whether Part 5 of the Regulations is fit for purpose; 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 review has found Part 5 does not meet these criteria.
Four key problems were identified in the review, specifically:
- Limited application of the testing framework;
- Prescriptive processes that are inflexible, unclear and burdensome;
- Complex and inefficient procedures regarding the evidentiary certificate; and,
- Insufficient protection for staff while performing their duties.
A number of legislative reforms have been proposed to strengthen and modernise the legislative framework for the examination, testing, and analysis of therapeutic goods. These proposed changes aim to improve the clarity and functionality of the arrangements in Part 5. These include:
- Broadening 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;
- Clarifying and streamlining processes and definitions;
- Amending procedures for the requirements, release of information and reliance on evidentiary certificate; and
- Expanding the provision for offences relating to intimidation of staff members in the conduct of their duties.
The TGA is seeking feedback from both consumers and industry on proposed reforms to ensure this improvement activity strikes the right balance of safety for patients without imposing unnecessary regulatory burden on industry.
The consultation closes on 18 August. Read the full consultation paper here.