Singapore Issues Guidance for Abridged Evaluation of New Drug Applications

Sponsors of new drug applications for life-saving drugs that have the potential to fill unmet medical needs may request a priority review if the submission is under an abridged evaluation route, according to a draft guidance issued by Singapore’s Health Sciences Agency. New drugs can be registered via the abridged method if the product has been assessed and approved by at least one regulatory authority. Drugs with no prior approval anywhere in the world must follow the full evaluation route, the draft notes.
International Pharmaceutical Regulatory Monitor