Reviewing Temperature Tolerable Limits when Conducting Stability Testing for Pharmaceutical Products in view of Global Warming

Ms Irene Quay Siew Ching
Nominated MP

Question No. 3113

To ask the Minister for Health (a) whether HSA is reviewing the temperature tolerable limits when conducting stability testing for pharmaceutical products, in view of global warming and temperatures in Singapore expected to hit 40 degree Celsius by 2045; and (b) whether the current stability testing limits at 30 degree Celsius is still valid, considering daily maximum temperatures frequently hitting above 34 degree Celcius.

Written Answer

1    The Health Sciences Authority (HSA) sets stringent standards on the quality of medicines sold in Singapore.

2   Manufacturers are required to conduct tests to demonstrate to HSA that the medicines remain of good quality throughout their shelf life. These include conducting long term stability studies under the condition of 30°C to establish the shelf life of the medicines, and at 40°C for a minimum period of 6 months to evaluate the impact of excursions to harsher conditions. The requirement adopted by HSA is in line with the most stringent international guidelines.

3     These test conditions are sufficiently robust to ensure the continued quality of our medicines, even with current temperature elevations. All our medicines are stored in HSA licensed premises where the temperatures are appropriately controlled to ensure that quality is maintained. Patients are also advised to keep their medications away from direct sunlight when storing them at home.

4     HSA recognises the potential impact of climate change on the quality of medicines. We have assessed that the current testing requirements are sufficiently robust considering the average annual temperature in Singapore have remained fairly consistent in the range of 27.5°C to 28.5°C since 2005 when the testing requirements were established. Nonetheless, we will continue to monitor local environmental changes and review the testing requirements where necessary. We will do this in collaboration with international regulators and our relevant stakeholders.