Regulatory Blog

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Jan 182 min read

MHRA Guidance: MAH Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing

Nitrosamines have become a significant concern in the pharmaceutical industry due to their potential carcinogenicity. In response to this...

Jul 2, 20232 min read

Australia's TGA: Reclassification of Surgical Mesh, Spinal Implants & Completing a Notification Form

Recently on 27th June, 2023 Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of...