RAFINT|Regulatory Affairs International

Entradas destacadas

PERU (15-SEP-2018): New Bioequivalence Regulation for Peru

17-Sep-2018

Luis Melendez

A new regulation was issued on 15-SEP-2018 requiring for the first time to submit interchangeability data for generics in Peru.

RAPS Convergence 2017: See you at Washington DC

7-Aug-2017

Luis Meléndez, Sr. Regulatory Affairs Manager RAFINT, will be attending the RAPS Regulatory Convergence at the National Harbor near the nation’s capital, 9–12 September, at the Gaylord National Resort and Convention Center. He will be open to address any questions you...

PERÚ: There are new clínical trial regulations. Ban on pediatric trials was lifted.

6-Jul-2017

Luis Melendez

On 30-JUN-2017, after two years, the Peruvian Ministry of Health has issued a new clinical trial regulation (Supreme Decree Nr. 021-2017-SA) that replaces the previous regulation from 2006 and repeals Supreme Decree Nr. 020-2015-SA that had set a moratorium on clinical...

PERU: DIGEMID will recognize GMPs from Several other LATAM countries

7-Jan-2017

The Peruvian governement just issued a modification to the law that govern medicines (*) that, among other changes, is mandating the Peruvian authority to recognize Good Manufacturing Practice certificates (GMPc) issued by "Level 4" regional reference National Regional...