Transition Plan for GMP Compliance by Drug Substance Manufacturers in Singapore

Singapore’s Health Sciences Authority (HSA) is rolling out a transition plan requiring Drug Substance (DS) manufacturers to meet Good Manufacturing Practice (GMP) standards. The plan includes submitting GMP Compliance Evidence, such as the US FDA’s Certificate of Pharmaceutical Product (CPP) for Active Pharmaceutical Ingredients (API), PIC/S manufacturing licenses, or inclusion in the EDQM inspection program. FAQs address submission requirements, applicability to existing products, and acceptance of manufacturers outside PIC/S jurisdictions. The policy applies to New or Generic Drug Applications (NDA/GDA) and Minor Variation Applications (MIV-1). From 30-Sep-2024, companies must provide GMP Compliance Evidence to ensure a smooth transition.

Source: https://www.hsa.gov.sg/therapeutic-products/guidance-documents
Region: Singapore