A few months ago, we reported on the significant revisions being made to clinical trials regulations in Singapore. At the time, the changes were put out for public consultation. The consultation has now been concluded, further revisions made, and the new regulations have been gazetted. The broad changes highlighted in our previous post, including a replacement of the old CTC system with a two-tier approval/notification system and consolidation of the regulations into the Health Products Act, were retained. These new regulations come into force 1 November, 2016. You can read more details about the new regulations on the HSA website; guidance documents will also be forthcoming.
There were a few changes between the consultation regulations and finalized versions that are perhaps worth highlighting briefly:
- Expanded penalties: Previously, violations of most provisions of the regulations were subject to penalties of up to $20,000 and 12 months’ imprisonment. More provisions are now subject to penalty, including failing to make proper reports; though some of the new reporting failure penalties come with a lighter maximum of $10,000 fine and 6 months’ imprisonment.
- Expanded labeling requirements: A Second Schedule has been added, significantly expanding the labeling requirements and procedures in clinical trials.
- Recategorised emergency research requirements: Emergency research regulations are now split into separate sections covering general emergency research application/notification and requirements for waiver of consent in emergency settings. At the same time, the provisions concerning family consent and withdrawal have been merged with the waiver of consent requirements section.