Generics Body Attacks WHO's 'Immature' Biological Qualifier Scheme

The World Health Organization's 'biological qualifier' scheme has its supporters and its detractors, with the former believing it will improve drug use and monitoring, and the latter thinking it at best superfluous and at worst a potential source of confusion and regulatory misalignment.

The World Health Organization's 'biological qualifier' scheme has its supporters and its detractors, with the former believing it will improve drug use and monitoring, and the latter thinking it at best superfluous and at worst a potential source of confusion and regulatory misalignment.

The generics industry in Europe, for example, has been sceptical of the scheme from the start, saying it is not...

More from Archive

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

 

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 

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 

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

 

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

More from Pink Sheet