Drug safety: HSA replies

We share Mr Joseph Khoo's views on the importance of ensuring the quality of active ingredients used in the manufacturing of pharmaceutical products ("Are ingredients used in drugs made here safe?"; Dec 7).

Pharmaceutical products that are marketed in Singapore are subject to stringent regulatory controls by the Health Sciences Authority (HSA).

Before these products can be marketed for use in Singapore, companies have to demonstrate that their product meets the required standards for quality, safety and efficacy, based on scientific data, including test data for active ingredients.

In addition, product manufacturers are required to comply with international standards for good manufacturing practice (GMP) according to the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

This is an internationally regarded GMP standard for the manufacture of pharmaceutical products, adopted by major regulatory authorities, including HSA.

Under the PIC/S, manufacturing premises are inspected by regulators for compliance with the stipulated regulatory standard to ensure compliance with quality systems on data integrity, traceability and reliability.

While pre-market approval of the pharmaceutical product and GMP inspection are not foolproof measures, particularly in circumstances of data falsification, the licensing system is complemented by post-market surveillance measures for ongoing monitoring of product quality and safety.

These include a risk-based approach to sample and test products on the market to ensure compliance with required standards.

HSA continues to enhance its oversight on the quality of pharmaceutical products through close collaboration with other overseas drug regulatory authorities when it is alerted to any potential quality issues that may arise from foreign suppliers.

This enables swift corrective action to be taken when necessary, to safeguard public health.

All reports of falsification of records impacting products marketed in Singapore are investigated by HSA.

On the international front, drug regulators, including HSA, are collaborating more closely to forge higher levels of controls and oversight on both local and foreign suppliers of pharmaceutical products.

Chan Cheng Leng
(Associate Professor)
Acting Group Director

Health Products Regulation Group
Health Sciences Authority

A version of this article appeared in the print edition of The Straits Times on December 16, 2015, with the headline 'Drug safety: HSA replies'. Print Edition | Subscribe