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The European Medicines Agency (EMA) is seeking feedback on the information needed for the approval of biomarker-guided medicinal products.

The Indian government has proposed immediately suspending the license of any company that produces a drug that is not of standard quality.

The Medical Device Coordination Group (MDCG) has published guidance on how clinical evidence requirements apply to orphan in vitro diagnostics (IVDs).

Australia’s Therapeutic Goods Administration (TGA) is holding consultations on information sharing under clinical trial schemes and its proposed comments on an international guideline for good clinical practice (GCP).

The European Medicines Agency (EMA) and its African counterpart have published a joint position paper to support the timely start of Ebola vaccine clinical trials.

Australia's Therapeutic Goods Administration (TGA) is holding a consultation into a planned temporary increase to medical device annual charges.

The European Medicines Agency (EMA) is holding a consultation into the methodological aspects of confirmatory platform clinical trials.

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published “review points” for medical devices using generative AI.

In January, the European Medicines Agency (EMA) will make permanent a pilot project that helps sponsors prepare clinical trial applications.

The Pharmaceuticals and Medical Devices Agency (PMDA) has published advice on ensuring the safety of healthy adult participants in Japanese bioequivalence studies.