Abstrait

A convergence of regulatory policies at FDA and EMA

Mallika Rajasekaran

 In December 2010 the EU parliament passed the XEVMPD [Article 57 (2)] regulation mandatingelectronicsubmissions to the EMA’s medicinal products dictionary. With the passing of this regulation, the EuropeanMedicines Agency also made public its plan to adopt ISO IDMP standards in support of ICH M5 initiative by 2015-16. The USFDA followed suit in August 2011 with the‘Advancing Regulatory Science Strategic Plan’. The FDA indicated that it will also mandate similar standards by 2015. Most important global pharmaceutical regulatory authorities including PMDA, Japan are expected to follow in ICH’s footsteps.