Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As reg­u­la­to­ry agen­cies look to catch up on in­spec­tions amid the Covid-19 pan­dem­ic, ICM­RA is un­veil­ing sev­er­al pi­lot pro­grams to ad­dress in­dus­try ap­pli­ca­tions and in­spec­tions.

ICM­RA, which is made up of the world’s top drug reg­u­la­tors, is launch­ing mul­ti­ple pi­lot pro­grams, in­clud­ing two reg­u­la­to­ry pi­lots ad­dress­ing fa­cil­i­ty in­spec­tions for chem­istry and man­u­fac­tur­ing con­trols (CMC) and post-ap­proval change (PAC) sub­mis­sion as­sess­ments and re­lat­ed reg­u­la­to­ry ac­tions.

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