The guide to register your drug in Singapore

Singapore is getting really popular among the life science firms who are looking for growth in the Asia Pacific region. Therefore, below is a guide compiled by BioSpectrum recently that might be useful to firms who are unsure about how the regulatory process works in Singapore.

The Health Products Regulations Group, a sub-division of Health Science Authority (HSA) is responsible to regulate all pharmaceuticals, biologics, medical devices and health-related products. Do take note that there will be different lead time for registration of generic drug and brand patent drugs are different.

If your drug application has been approved by any overseas regulatory agencies, an abridged dossier has to be submitted to HSA for abridged evaluation and regulatory decision. This whole process will take around 180 and 240 working days for branded patent drugs and generic drugs respectively.

In cases if the approval was given by HSA's reference regulatory agencies (examples are US FDA, Health Canada, Australian TGA), only a verification dossier is required to be submitted for evaluation and regulatory decision based on the reference regulatory agency. This will be the fastest, taking around 60 working days for branded patent drugs to get the approval. As for generic drugs, it will take around 120 working days instead. However, if it has not been approved by any agency, a full dossier has to be submitted. This process will be a lot longer, taking on an average of 270 working days for new drugs.

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