Singapore: New safety reporting requirements for registered medicinal products
Excerpt from the Pacific Bridge Medical (PBM) Asian Medical e-Newsletter (Volume 5, Number 1, April, 2005)
In February 2005, Singapore’s Center for Drug Administration (CDA) released new guidelines on safety reporting requirements for registered medicinal products. The new guidelines apply to license holders who are responsible for bringing western medicinal products into Singapore. The guidelines define the types of safety-related reports that license holders are required to provide to the Pharmacovigilance (PV) Unit of the CDA and also define the timeline for which to do so. The new requirements cover three different types of safety reports: spontaneous suspected adverse drug reaction (ADR) reports, periodic safety update reports, and reports regarding regulatory actions or actions taken by companies due to safety issues.
Spontaneous suspected ADR refers to clinical observations of adverse reactions that originate outside of a formal study. Once a possible causal relationship is found between an ADR and the medicinal product in question, the license holder must submit a spontaneous suspected ADR report to the PV Unit of the CDA. This report must be submitted within 15 calendar days from the time any personnel of the license holder is made aware of the ADR. The report must be filed even if the license holder does not agree with the initial clinical observation.
Periodic safety update reports (PSURs) may be requested by the CDA for certain kinds of registered medicinal products. License holders of selected medicinal products must submit a PSUR to the Product Evaluation & Registration Branch of the CDA every 6 months for the first two years after market approval. After two years have passed, a PSUR must then be submitted yearly for the next three years. The CDA recommends that license holders of products not requiring a PSUR still maintain a summary report on safety data. If the CDA requests this kind of report it must be submitted within 30 calendar days.
If safety concerns cause regulatory actions to be taken by other regulatory authorities, or actions to be taken by the product owner itself, the license holder must notify the PV Unit of the CDA within 7 days. Significant safety concerns that require reporting include: product withdrawal/recall, removal of approved indications by regulatory agencies, failure to obtain product license renewal, etc. Reports of this nature must describe the safety related reasons why actions were taken, review the consequences of the actions taken and also include recommendations on follow-up actions to be carried out locally.