Vibha is a senior writer covering pharmaceutical and medtech regulatory developments across the globe. She plays a key role in tracking and writing about news of important regulatory issues affecting the sectors, and explaining their implications for industry. Vibha's fields of interest include the EU regulations on clinical trials, pharmacovigilance and pediatrics, on which she has written several exclusive articles from various industry conferences. She has also commissioned some pieces of expert analysis on major developments in the pharma and medtech regulatory arenas.
Latest from Vibha Sharma
The EMA has voted in favor of EU approval for five new products, including treatments for a rare, life‑threatening genetic disorder and for non‑cirrhotic MASH, and has also recommended reversing its earlier rejection of an orphan drug for chronic graft‑versus‑host disease.
The UK MHRA says it is ready to deliver the new Clinical Trials Regulation, which aims to balance faster review of trial applications with greater flexibility to deliver a competitive, innovation-friendly clinical research ecosystem.
The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including therapies for a serious liver disease and an ultra‑rare genetic mitochondrial disorder.
As Europe races to reclaim its share of commercial clinical trial activity, regulators are testing whether faster approvals and shorter setup timelines will be enough to restore sponsor confidence, attract biotech investment, and secure the region’s place in global drug development.
The EU public‑private Trials@Home consortium put seven decentralized clinical trial elements to the test through its proof‑of‑concept RADIAL study to generate learnings on how to scale such trials in the future.
Medsafe’s latest update of New Zealand’s clinical trial guidelines aligns with international standards and clarifies expectations on patient‑centric design, streamlined safety reporting, and other regulatory requirements.