HSA Intends to Consolidate the Current Legislative Controls for Medicines

Global Life Sciences: Singapore/South East Asia Update

The Health Products Regulation Group (HPRG) of the Health Sciences Authority (HSA), the authority administering the regulations of drugs, medical and health products, cosmetic and medical devices in Singapore, has announced that it intends to consolidate the current legislative controls for medicines (which are currently spread over different legislation including the Medicines Act, Sale of Drugs Act, Poisons Act, etc.) into a single legislation, the Health Products Act (HPA).

  • The HPA, which came into force in 2007, currently applies only to medical devices and cosmetic products. A lateral transfer of controls and regulatory framework for other products, especially “Western” medicines, is currently targeted by the second half of 2011.
  • The HSA is likely to adopt a more risk-based and modular approach towards regulation and a more activity-based and streamlined licensing system is expected under the new regime. For example, under the new regime, only one importer’s license would be required for those who wish to import a “Western” medicine which contains a poison listed in the current Schedule to the Poisons Act. The importer will be exempted from obtaining a separate Form A license as required under the current Poisons Act.

The HPA also aims to tackle issues such as the regulation of counterfeit products and adulteration of medicinal products. There are also plans to regulate eye drops as medical devices.

Singapore/South East Asia Life Sciences Practice

Established in 1982, Sidley’s Singapore office is the firm’s South East Asian regional base. Our Singapore Life Sciences team serves multinational and local life sciences clients , with the assistance of qualified local counsel, in multijurisdictional matters in Singapore, Indonesia, Thailand, Vietnam, India and Malaysia involving:

  • Corporate Transactions, including Mergers & Acquisitions, Joint Ventures, Licensing and Privatizations
  • Enforcement, Arbitration and Litigation, including FCPA and Anti-Corruption
  • Regulatory and Compliance

For further information on the Singapore/South East Asia Life Sciences Practice, please contact: Yuet Ming Tham (+852.2509.7645, yuetming.tham@sidley.com).

Global Life Sciences Practice

On three continents, Sidley’s Global Life Sciences Practice team offers coordinated cross-border and national advice on Food, Drug and Medical Device Regulatory, Life Sciences Enforcement, Litigation and Compliance, Healthcare Regulatory, Products Liability, Intellectual Property, Corporate and Technology Transactions, Securities and Corporate Finance, International Trade and Arbitration, FCPA/Anti-Corruption, Antitrust/Competition, Environmental/Nanotechnology. Globally rated as one of the top life sciences practices, our team includes former senior government officials, medical doctors and leaders in various life sciences fields.

For further information on the Global Life Sciences Practice, please contact: Scott Bass (+1.202.736.8684, +1.212.839.5613, sbass@sidley.com) or James C. Stansel (+1.202.736.8092, jstansel@sidley.com).

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This Global Life Sciences: Singapore/South East Asia Update has been prepared by Sidley Austin LLP for informational purposes only and does not constitute legal advice. This information is not intended to create, and receipt of it does not constitute, a lawyer-client relationship. Readers should not act upon this without seeking advice from professional advisers.