Singapore’s Health Sciences Authority (HSA) held its second consultation on proposed subsidiary legislation to consolidate regulatory controls for pharmaceutical products under the Health Products Act (Cap 122D) (HPA). The proposed changes will expand the definition of health products covered under the legislation and affect the licensing regime for the manufacture, import and supply of pharmaceutical products as well as postmarketing obligations and the conduct of clinical trials for these products.
This is part of the HSA’s ongoing initiative, since 2012, to bring the regulation of pharmaceuticals governed under the Medicines Act (Cap 176) and the Poisons Act (Cap 234) under the HPA. The HSA aims for these changes to streamline existing regulatory controls, strengthen the legislative framework in line with international standards and enhance regulatory efficiency.
The key changes:
- Defining a “therapeutic product” based on its purpose and active ingredients, rather than solely its purpose, as defined under the Medicines Act. This would incorporate products conventionally regarded as pharmaceuticals, i.e., chemical and biologic drugs.
- Consolidating the license application process for the registration, manufacture, import and wholesale of therapeutic products in Singapore under one law.
- Transitioning to an activity-based and tiered licensing regime, whereby the level of licensing requirements and fees will be calibrated according to the scale of activities and types of products the company deals with.
- Various licensing obligations, including mandating the naming of a responsible person when obtaining an importer’s license (IL) and a wholesaler’s license (WL) and requiring an IL to import therapeutic products containing scheduled poisons for certain activities.
- New postmarket obligations, including the duty to implement risk management activities as well as to maintain records of, and report within 15 days, defects and adverse effects. Defects that represent a serious threat to persons or public health must be reported within 48 hours.
Introducing a risk-based regulatory framework to clinical trial regulation and requiring the publication of more detailed information on clinical trials.
The HSA has ensured that it will work closely with the industry to minimize regulatory and business impact while implementing changes to the licensing regime.