FDA and EMA sig­nal an op­por­tu­ni­ty to har­mo­nize ad­vanced ther­a­py reg­u­la­tions

As reg­u­la­tors around the world pre­pare for an in­flux of new ad­vanced ther­a­py ap­pli­ca­tions for cell and gene ther­a­pies (the Al­liance for Re­gen­er­a­tive Med­i­cine pre­dicts 10 to 20 ap­pli­ca­tions an­nu­al­ly by 2025), lead­ers at the FDA and EMA are now call­ing for more har­mo­niza­tion around their re­spec­tive reg­u­la­tions.

Part of the prob­lem is that many of these ex­pen­sive ther­a­pies tar­get or­phan or ul­tra-or­phan in­di­ca­tions, which can cre­ate vi­a­bil­i­ty prob­lems for de­vel­op­ers. But en­ter­ing mul­ti­ple mar­kets si­mul­ta­ne­ous­ly may re­lieve some of those is­sues.

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