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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

New MHRA Guideline Could Be Global Pharma's Go-To Standard For GxP Data Integrity

The UK regulator has done a good job of aligning its final data integrity guideline with those of other international bodies, which means global drug companies will not have to balance competing requirements to achieve compliance, says consultancy firm Rammell. However, some aspects of the guideline, such as following a risk-based approach, could pose some challenges.

Regulation United Kingdom

Malaysia Consults On Facilitating Exports By Original Equipment Manufacturers

The Malaysian medtech regulator has issued a new circular and a related draft guidance to facilitate the export of medical devices manufactured by original equipment manufacturers.

Malaysia Regulation

EMA Explores How To Make Therapeutic Indication Wording More Consistent

A reflection paper being drafted by the European Medicines Agency is seeking to eliminate the current variability relating to how therapeutic indications are defined in the summary of product characteristics. 

Regulation Europe

Roche Convinces UK NICE On Cost-Benefit Of RoActemra For Giant Cell Arteritis

After an initial rejection, Roche's IL-6 drug RoActemra has received support from the UK's health technology assessment body to treat giant cell arteritis in a subset of patients, provided the treatment with the drug is permitted for one year at the most.

Cost Effectiveness Health Technology Assessment

EU Regulators Address Challenges In Switching Reference Member State

EU member state regulators have issued updated advice for marketing authorization holders wanting to change their reference member state for medicines evaluated through the mutual recognition and/or decentralized procedures. The document notes that Brexit is now an accepted reason for a switch of CMS, and explains how to make the switch in cases where all the strengths of the drug are not approved in any concerned member state.
Brexit Regulation

Pharma Welcomes UK-Wide Applicability Of Revised Model Clinical Trials Agreement

The pharmaceutical industry has welcomed the UK's updated model clinical trials agreement that sponsors can now use to rapidly sign off contracts when undertaking clinical trials in hospitals run by the national health services throughout the country.
Clinical Trials Regulation
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