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The Indian government is preventing applicants who submit misleading, fake, or fabricated documents from filing further requests with regulatory authorities.

The Therapeutic Goods Administration (TGA) has proposed adopting 11 international scientific guidelines for use in Australia.

Australia’s Therapeutic Goods Administration (TGA) recently announced that it has adopted 23 international scientific guidelines from European Medicines Agency (EMA), the International Council for Harmonisation (ICH), and the US Food and Drug Administration (FDA).

Australia’s Therapeutic Goods Administration (TGA) is holding a consultation to inform changes to the regulatory framework for digital mental health tools (DMHTs).

The Indian government has strengthened oversight of cell and gene therapies by bringing the novel modalities into the Centrally License Approving Authority (CLAA) framework.

Among oncology drugs first approved by the US Food and Drug Administration, other regulatory authorities varied in how they approved the same products, both in terms of the regulatory frameworks and the evidentiary thresholds used as the basis for the approvals, according to recent research published in Frontiers in Pharmacology.

Australia’s Therapeutic Goods Administration (TGA) is holding a consultation on its plans to publish good manufacturing practice (GMP) certificates and inspection outcomes.

The Pharmaceuticals and Medical Devices Agency (PMDA) published guidance on using a weight of evidence (WOE) approach to assessing the toxicity of monoclonal antibodies in Japan.

The New Zealand government has adopted rules on “consent by verification,” creating a pathway that will fast-track the review of medicines approved by two or more reference regulatory agencies.