In brief

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. 

Background

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.

Objectives

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 activi...