New Singapore Rules Will Impact Drug Licensing, Trials, Surveillance

New proposed legislative changes to Singapore’s drug approval, clinical trials and post-marketing surveillance requirements are part of the island state's ongoing initiative to update and streamline its regulatory controls for health products and bring them under a single legislation.

The steps will introduce new obligations for pharmaceutical companies, said Yuet Ming Tham, a partner at the Hong Kong office of international law firm Sidley Austin.

They concern new requirements relating to, for example, the licensing regime and post-market surveillance controls (including risk management plans, benefit-risk evaluation reports and record-keeping), Tham, told PharmAsia News’s sister publication Scrip Regulatory Affairs.

As such, companies may "need to update their compliance policies and procedures to accommodate these procedures, determine in which areas of their practice they have additional obligations, and expend more effort complying with these requirements," she said.

Tham noted that an official date for when the proposed changes will become law has not been released.

The proposed changes are part of the initiative that Singapore's Health Sciences Authority began in 2012 to consolidate the regulation of pharmaceuticals governed under the Medicines Act and the Poisons Act into the Health Products Act, which originally only regulated medical devices.

A consultation on the latest proposed changes has now taken place. It followed a previous consultation on proposals to replace Singapore's pre-approval system for drug advertisements with a new mechanism that would allow the pharmaceutical industry to self-regulate based on a set of rules and guiding principles.

Enhancing Regulatory Efficiency

The general goals of the HSA in implementing these changes are to "enhance regulatory efficiency and provide greater clarity to companies, as well as to safeguard consumer safety," Tham said, noting that the HSA was "aiming to make for a smooth transition."

According to a Sidley Austin statement, the latest proposed changes involve:

• 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 and a wholesaler's license, and requiring an importer's license to import therapeutic products containing scheduled poisons for certain activities;
• new post-market 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;
• and introducing a risk-based regulatory framework to clinical trial regulation and requiring the publication of more detailed information on clinical trials.

"We recommend that pharmaceutical companies understand, and where necessary, consult counsel on their new obligations to ensure they comply with the proposed amendments," Tham told SRA. "In particular, pharmaceutical companies should consider reviewing their procedures for licensing, conducting clinical trials, and responding to post-market surveillance in light of upcoming changes."

(This article also appears in Scrip Regulatory Affairs. PharmAsia News brings selected complementary coverage from our sister publications to subscribers.)