The Australian Therapeutic Goods Administration (TGA) has revised it's "Guidance on Clearance of Products Manufactured Overseas". The draft has been published in September 2010. It will replace TGA's 2008 Guidance. Deadline for comments is November 15, 2010.
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.
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!
TGA/ Australian regulatory guidelines for GMP clearance for overseas manufacturers
TGA/ Draft guideline for consultation (pdf, 197kb)