What's new?

• Sponsors with submitted applications will no longer be contacted prior to including them in the program.

• Regarding alternative processes, TGA is still allowing manufacturers that had an on-site inspection in 2018/2019 to complete a GMP Clearance questionnaire to verify their compliance.

A prioritisation of inspections for overseas manufacturers will be based on:

• the ability to use the alternative GMP Clearance processes
• current compliance information
• applications for marketing authorization

Mutual Recognition Agreements, MRAs

• TGA is liaising with regulatory partners worldwide and considers their range of approaches taken when it comes to remote GMP inspections. A large number of GMP clearances involving MRA partners will expire at the end of the year. Therefore, the most current evidence issued by MRA partners are accepted for both new and renewal applications.
• Additionally, an extended validity of the GMP clearances will be gained for relevant new and renewal applications submitted and paid after 1 July 2021. TGA specifically mentions the European EMA and the EMA Guidance document as guidance and advice partner for this step.

Please find all necessary information on this topic on the corresponding TGA website.

Source:

TGA: On-going use of remote inspections