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Brazil Issues Guidance On Regulatory Reliance & Equivalent Authorities

Mexico and Brazil set sights on GMP convergence

 
• By Francesca Bruce

Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.

bRAZIL
Brazil advances regulatory reliance • Source: Shutterstock

In the latest move to advance regulatory reliance in Brazil, the country’s medicines regulator, Anvisa, has approved new guidance setting out criteria for making use of pre- and post-market drug evaluations carried out by the foreign authorities it deems to be “equivalent” regulatory bodies.

The guidance, published this week, relates to registration and post registration studies of medicines, vaccines and biological products. It establishes...

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Danish Medicines Agency Wants Companies To Use “Better Data Format” To Submit Bioequivalence Studies

 
• By Anabel Costa-Ferreira

The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.

England’s NICE Hunts For New Chief As Sam Roberts Prepares To Step Down

 
• By Eliza Slawther

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NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

 
• By Nielsen Hobbs and Derrick Gingery

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