EMA up­dates on reg­u­la­to­ry ex­pec­ta­tions amid Covid-19

The EMA on Mon­day up­dat­ed its re­cent ques­tion and an­swer guide­line on reg­u­la­to­ry ex­pec­ta­tions for med­i­c­i­nal prod­ucts amid the coro­n­avirus dis­ease (Covid-19) pan­dem­ic.

The guide­line, de­vel­oped in col­lab­o­ra­tion with the Eu­ro­pean Com­mis­sion and Heads of Med­i­cines Agen­cies, in­cludes four new ques­tions and an­swers con­cern­ing good man­u­fac­tur­ing prac­tice (GMP) and good dis­tri­b­u­tion prac­tice (GDP) cer­tifi­cates, qual­i­fied per­sons (QP) and ad­verse event re­port­ing. (RE­LAT­ED: EMA Q&A ex­plains reg­u­la­to­ry ex­pec­ta­tions for drugs dur­ing the pan­dem­ic, Reg­u­la­to­ry Fo­cus 10 April 2020).

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