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EMA agrees on "black triangle" for new drugs launched in EU

 
• By Ian Schofield

All new products launched in the EU will have to display a black inverted triangle on their product information to denote that the product is subject to additional monitoring if the European Commission accepts the advice of the European Medicines Agency’s new pharmacovigilance committee, the PRAC1.

All new products launched in the EU will have to display a black inverted triangle on their product information to denote that the product is subject to additional monitoring if the European Commission accepts the advice of the European Medicines Agency’s new pharmacovigilance committee, the PRAC1.

Under the EU pharmacovigilance legislation of December 2010, the EMA has to draw up a publicly available list of medicines...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.