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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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Latest From Vibha Sharma

Australia Accepts Approvals By More 'Comparable' Overseas Regulators/Bodies

Australia has decided to make greater use of medical device approvals in overseas markets to improve consumer access.

Australia Policy & Regulation

Canadian Guidance On Pre-Market Cybersecurity Requirements Expected This Year

Canada's pre-market evaluation process for medical devices will soon include evaluating the adequacy of a manufacturer's risk control measures to address cybersecurity concerns.

Canada Policy & Regulation

EFPIA Suggests Improvements To EMA's Revised Guideline For Diabetes Mellitus Products

EU industry body says it is unclear why different requirements have been proposed for approving a monotherapy indication as compared with an add-on or combination indication.
Europe Clinical Trials

WHO Consults On New Measures To Improve Medicines Access

A draft roadmap lists initiatives to be undertaken between 2019 and 2023 to help improve access to medicines and vaccines. 
International Market Access

UK MHRA Spells Out Do's And Don'ts Of Real-World Evidence For Showing Efficacy

A senior UK regulator explains why the MHRA agreed to a complex real-world evidence study instead of an RCT to demonstrate a drug's efficacy, despite the challenges posed by potential for bias.
United Kingdom Clinical Trials

ICH Evaluates Guideline Uptake By New And Old Members

The study will be undertaken by an independent third party and its results will help facilitate a transparent dialogue on the long-term goal of ensuring that all the ICH regulators implement all the ICH guidelines.
International Regulation
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