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Vibha Sharma

Vibha Sharma is a senior reporter covering pharmaceutical and medtech regulatory developments across the globe. She joined Scrip Regulatory Affairs in September 2010 and has since then been at the center of deciding and writing news on important regulatory issues affecting the pharma and medtech sectors and explaining their implications for the industry.

Her fields of interest include the EU Pharmacovigilance legislation and the EU Paediatrics Regulation 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.

Before joining Informa, she was principal correspondent with India's national newspaper Hindustan Times, where she reported on health and medical issues, besides several other topics. She has also worked with two other Indian national dailies, The Indian Express and The Asian Age.

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EU Launches Joint Assessment Of Pediatric & Orphan Drugs Legislation

A new European Commission consultation marks the launch of an evaluation exercise to assess the joint impact of the EU pediatric and orphan drugs legislation in supporting the development of pediatric medicines for rare diseases.
Europe Pediatrics

Australia Requires Patient Cards With All New Implants From Dec. 1

Requirements relating to patient cards and information leaflets for all implantable medical devices are based on the new EU medtech rules, but Australia has chosen to implement these earlier to address consumer information gaps.

Australia Policy & Regulation

Study On Patient Support Program Impact Piques EMA's Interest

The pharmaceutical industry's renewed effort to find a pragmatic solution to managing adverse events from patient support programs has drawn the European Medicines Agency's attention.

Europe Drug Safety

EMA To Discuss Reactivating Landmark Clinical Trials Transparency Policy

The European Medicines Agency will be looking at reviving its policy on proactive publishing of clinical study reports, which is currently suspended as the agency copes with huge staff losses on account of Brexit.
Europe Brexit

EMA Urged To Expand 'Unmet Needs' Definition To Support New Antibiotics

The European Medicines Agency should consider policies that would allow new antibacterial products for serious and life-threatening infections to qualify for an expedited review, the pharmaceutical industry has suggested.

Europe Clinical Trials

EMA Acts On Patient Concerns Over Fluoroquinolone Antibiotics

Three months after hearing testimonies of patients who suffered severe side-effects from the use of quinolones and fluoroquinolones, the European Medicines Agency has recommended that some of these medicines should be removed from the market and the labeling of others should be changed to restrict their use.


Europe Drug Safety
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