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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

Eight Months And Counting: Santen Still Waiting For Final Marketing Decision On Drug Fast-Tracked By EMA

It has been eight months since the European Medicines Agency recommended market approval for a drug that was reviewed under its fast-track mechanism, but the sponsor has yet to receive a final decision from the European Commission. The company ran into problems when seeking to renew the drug's orphan status before approval.
Drug Approval Standards Regulation

Saudi FDA Consults On Regulating Device Software, Distribution Requirements

Saudi Arabia has proposed adopting IMDRF guidelines on the regulation of medical device software. It has also issued a separate proposal to help medical device establishments comply with national regulatory requirements on the storage, handling and distribution of medtech products.

Policy & Regulation Safety

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
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