Singapore's Health Sciences Authority improves the regulatory regime for therapeutic products

05 January 2015

In 2012, the Health Sciences Authority (HSA), a statutory board of the Ministry of Health of Singapore, introduced the concept of "therapeutic products" and proposed to cover the key regulatory aspects for pharmaceutical products, including manufacture, product registration, import, supply, clinical trials, presentation, advertisement, adverse event reporting and enforcement through an "omnibus" legislation, the Health Products Act (Cap.122D) (HPA). This is a part of the Ministry of Health's continual efforts to increase efficient regulation using a calibrated integrated risk approach.

In a "series-of-steps" approach, the HSA announced the first of the four sets of proposed legislative amendments. In November 2014, the HSA concluded public consultations announcing the transfer of existing regulatory controls and licensing of retail pharmacies from the Medicines Act (Cap. 176) to the HPA. The fundamental controls for retail pharmacies including the supply of "therapeutic products" by retail pharmacies under the existing law will be retained and transferred to the HPA.  

Further, the proposed legislation moves the pre-approval permit system for advertisement controls for "therapeutic products" to industry self-regulation. The HSA believes that information is readily available to the public in Singapore and that such self-regulation line with international best practices. This will empower the industry to generate health product-related information that enables public to make informed choices, while the HSA will continue to focus on post market controls and oversight.  The proposed amendments to the HPA also include matters that are to be excluded from advertisements including comparisons against other "therapeutic products" or give the impression of endorsements of any healthcare professional or any celebrity.

  • Finally, to address the growing regulatory challenges posed by internet platforms for online purchasing of drugs and medicines, the proposed legislation puts in place a licensing regime for retail pharmacy services supplied online by registered retail pharmacies. Approvals for the "telepharmacy license" will require fulfilment of the following:
  • (a) necessary technology set up and capability for delivery of such services;
  • (b) adequately trained personnel; and
  • (c) written procedures for services rendered.



Marcus Chow


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