Tech alert: TGA Consultation – Guidelines for the Quality of Listed Probiotic Medicines

The TGA has announced a public consultation on the proposed New Guidelines for the Quality of Listed Probiotic Medicines. It applies to quality expectations for finished products that are listed or assessed listed medicines [AUST L or AUST LA].

The consultation is open from today, 24 July 2023, until Sunday 10 September 2023.As a public consultation, the TGA will receive comments from any person or group. We encourage your feedback to also be submitted to CMA

– Members are urged to review the proposed guidelines to determine if any aspects cause a concern for your business.

The stated purpose of the Guidelines is to:

– help sponsors and manufacturers meet the regulatory requirements to ensure the quality of their probiotic medicine is acceptable under the Therapeutic Goods Act 1989 (the Act); and

– assist with sponsor and manufacturer compliance by naming and explaining the most relevant applicable legislation related to ensuring the quality of probiotic medicines.

Please read today’s full technical alert for more information, including relevant background, transition information, consultation questions and details on how to respond to the consultation.

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