AustralianTherapeutic Goods Administration (TGA) Australian

TGA Updates GMP Clearance Guidance for Overseas Facilities

January 10, 2019

Australia’s Therapeutic Goods Administration (TGA) has updated its GMP clearance guidance for overseas manufacturing facilities, providing more information on application fees, agreements and information needed for extension applications.

The guidance lists fees required for each type of application. For example, a TGA certificate requires only an application processing fee. Mutual recognition agreements require an application fee and may also require “obtaining evidence” fees.

The guidance also clarifies when applications will be dropped from the system due to nonpayment and includes a section on troubleshooting and staying up to date with guidance updates.

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