Australia Updates GMP Clearance Guidance with Application Processing Times

Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on GMP clearance regulations for overseas manufacturing facilities, clarifying the agency’s processing timelines for various applications.

The revised guidance explains to manufacturers how long they should expect the TGA’s application processing to take — which can range from one to four months in working days depending on the type of GMP clearance application.

Mutual recognition agreement GMP clearance applications typically take 30 days, the guidance says, while compliance verification for non-sterile APIs usually takes sixty days. Compliance verifications for sterile/biotech APIs, non-sterile finished products and sterile/biotech finished products may take approximately 75, 90 and 120 days, respectively, for TGA to process.