November 2020: Spain Regulatory Updates

Spain Royal Decree 957/2020, of November 3, regulating observational studies with drugs published on November 27, 2020

  • The Official State Gazette has published Royal Decree 957/2020, of November 3, which regulates observational studies with medicines for human use, and will come into force on January 2, 2021
  • This Royal Decree will replace the regulations currently in force, Order SAS / 3470/2009, and Chapter VI relating to Post-authorization Studies of Royal Decree 577/2013
  • For observational studies with drugs to which the previous one no longer applies regulations (not classified by the AEMPS), the prospective publication will be mandatory for the promoters of the follow-up studies and the information to be published at the beginning of the study will include, at least, the title, promoter, drugs under study, main objective and sources of financing.
  • The publication of information in the REec will be mandatory for  observational studies with prospective follow-up drugs and voluntary for the rest of observational studies with drugs.

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