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A trade group has asked European authorities to give notified bodies access to the Eudamed database to empower them to deliver the risk-based oversight proposed in the pending medtech regulatory reforms.

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

The European Medicines Agency (EMA) is running a consultation into plans to streamline the nonclinical development of treatments for severely debilitating or life-threatening diseases.

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

EFPIA has called for lawmakers to go beyond the reductions in clinical trial approval times proposed in the Biotech Act.

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).

The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.

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

The European Medicines Agency (EMA) has released guidance on technical and organizational measures that companies should consider to prevent microbial contamination of non-sterile products.

India’s National Pharmaceutical Pricing Authority (NPPA) has announced price reductions for more than 30 drugs and biological products as part of a recent revision to the country’s drug pricing legislation.