Could MDMA’s UK approval be fast tracked by forthcoming Reciprocal Drug Approval Procedure with FDA?

This piece in Psychedelic Alpha's February 20 Bulletin reads: "As post-Brexit Britain tries to find its feet in a post-Brexit context, it’s slowly shedding eurocentric regulations and conventions. This includes the European Commission (EC) Decision Reliance Procedure, which states that the UK’s MHRA “may rely on a decision” taken by the European Commission on the approval of a marketing authorisation for a drug. The procedure, introduced in January 2021, has been extended until the end of this calendar year – as has become common practice with other post-Brexit untanglings. The interesting part is what might come next. In a note published in late January, the MHRA explained that its aim is to, “extend the countries whose assessments we will take account of, increasing routes to market in the UK.” While information on who these additional regulators might be is not yet available, it’s likely that any international recognition framework would include the FDA. With this international recognition framework expected to launch on January 1st, 2024, might MAPS PBC’s MDMA-assisted therapy for PTSD be among the first products considered under this new reciprocal drug approval pathway?"

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