Transition Plan for Drug Substance Manufacturers in Singapore: GMP Compliance Requirements

Singapore’s Health Sciences Authority (HSA) is implementing a new transition plan that mandates Drug Substance (DS) manufacturers to adhere to Good Manufacturing Practice (GMP) standards. This initiative requires companies to submit appropriate GMP Compliance Evidence to ensure products meet the necessary safety, quality, and regulatory requirements.

Key Highlights of the Transition Plan:
GMP Compliance Evidence Submission:

Manufacturers will need to provide GMP Compliance Evidence when submitting new or generic drug applications (NDA/GDA) and minor variation applications (MIV-1). Acceptable forms of evidence include:
US FDA Certificate of Pharmaceutical Product (CPP) for Active Pharmaceutical Ingredients (API).
PIC/S (Pharmaceutical Inspection Co-operation Scheme) manufacturing licenses.
Inclusion in the EDQM (European Directorate for the Quality of Medicines) inspection program.
Submission Requirements and FAQs:

The HSA has released a set of Frequently Asked Questions (FAQs) to clarify submission requirements, including guidance on the applicability of these rules to existing products and whether manufacturers outside PIC/S jurisdictions can submit their evidence for approval.
Applicability:

The new GMP requirements apply to both New Drug Applications (NDAs), Generic Drug Applications (GDAs), and Minor Variation Applications (MIV-1), including any changes made to already marketed products that affect their GMP status.
Transition Date:

Starting from 30-Sep-2024, companies will be required to submit GMP compliance evidence as part of their regulatory submissions. This transition plan ensures that all products meet current manufacturing standards and support the ongoing safety and quality of pharmaceutical products in Singapore.
By aligning with these updated requirements, manufacturers will help ensure a smooth transition to GMP compliance and maintain regulatory standards in Singapore’s pharmaceutical industry.

Resource: https://www.hsa.gov.sg/therapeutic-products/guidance-documents

Region: Singapore