The draft widely refers to PIC/S (Pharmaceutical Inspection Cooperation Scheme) Guidelines.Thus the Australian TGA furthers progress in harmonizing their Guidelines with the PIC/S Documents. Main objectiv of this TGA Guideline is to regulate the GMP requirements concerning the import of Medicinal Products and APIs to Australia.

The main changes concern the following topics:

• clarification of assessment requirements and processes for getting GMP clearance for overseas manufacturing sites
• the addition of a list of sponsor responsibilities in obtaining and maintaining those clearances
• amended evidential requirements to address difficulties experienced by sponsors in obtaining particular documents from regulators and manufacturers (including delays in the release of inspection reports)
• a description of the criteria used for granting Clearance approval and determining its duration
• the addition of TGA performance timeframes for the assessment of applications
• new provisions describing the circumstances in which an application will be rejected or lapse
• the addition of procedures for the review of GMP clearance assessments

Deadline for comments: November 15, 2010.

Outcome:

Your company is exporting Medicinal Products and APIs to Australia? Then it's up to you checking this revised Guideline intensively and exercise your right to comment the Draft!

Links:

TGA/ Australian regulatory guidelines for GMP clearance for overseas manufacturers

TGA/ Draft guideline for consultation (pdf, 197kb)