On 17 July 2023, the Health Sciences Authority (HSA) proposed the new regulation for active ingredients under the Health Products Act.
Against the increasing complexity in the manufacturing and supply chain of active ingredients, streamlined and risk-based regulatory controls will ensure that active ingredients consistently meet appropriate quality standards. The HSA has therefore seen the need to consolidate and enhance regulatory controls for active ingredients under the Health Products Act.
In more detail
Active ingredients are pharmacologically active substances that may be used to manufacture health products, including therapeutic products, cell tissue or gene therapy products, and medical devices. They are presently regulated under the Poisons Act and Medicines Act.
To consolidate and enhance regulatory controls so that the manufacture and supply of active ingredients consistently meet appropriate quality standards, the HSA has proposed consolidating the regulatory controls for active ingredients under the Health Products Act. Once the regulation under the Health Products Act is implemented, regulatory controls for active ingredients under the Poisons Act and the Medicines Act will no longer apply.
The HSA’s key objectives driving the proposed new regulation for active ingredients under the Health Products Act are the following:
- To safeguard public health by ensuring the consistent manufacture, storage and distribution of active ingredients with quality standards appropriate for the intended use
- To provide a fit-for-purpose and risk-based licensing framework aligned with international standards and to increase mutual confidence with overseas counterparts
- To streamline the regulation of active ingredients under a single legislation and to increase clarity of legal requirements and regulatory controls
Key proposed legislative changes
First, the proposed regulation will specify in a schedule the active ingredients that will be regulated. These scheduled active ingredients would be those that are usable as pharmacologically active constituents in the manufacture of therapeutic products, cell tissue or gene therapy products that are not a result of only minimal manipulation of cell or tissue, and/or medical devices.
Second, the HSA will adopt a risk-based regulatory approach for activity-based licensing of manufacturers, importers and wholesalers of active ingredients based on their risk profiles.
For instance, inspection and licensing controls will apply to all manufacturers, importers and wholesalers of active ingredients used in health products for local clinical use. In contrast, importers and/or wholesalers performing lower-risk activities where active ingredients are intended for non-clinical purposes such as scientific research, use in animals and other applications not involving humans, will be subject to less stringent requirements.
Licensed importers and wholesalers of active ingredients will no longer need to hold a separate Form A Poisons License under the Poisons Act.
The proposed new regulation may be accessed here.
The HSA welcomes feedback on the proposed regulation for active ingredients. Feedback may be provided here until 17 August 2023.
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