FDA & EMA Updates

The start of the new year brought some changes for the FDA and EMA. In an effort to keep you up to date and informed, we compiled the updates here:

  • The EMA has outlined a harmonized approach to develop and use electronic product information (ePI) for human medicines across the EU. This will address some of the limitations current product information (PI) has such as interoperability with other electronic health systems. For more information on ePI, refer to this document.
  • The EMA’s human medicines committee recommended 15 medicines for approval at its January 2020 meeting, including the first oral GLP-1 treatment for type 2 diabetes and the first treatment for acute hepatic porphyria in adults and adolescents ages 12 years and older.
  • The UK left the EU on January 31, 2020, but the transition period lasts from February 1 to December 31, 2020. During this period, EU pharmaceutical law is applicable in the UK. Marketing authorization holders/applicants, Qualified Persons for Pharmacovigilance (QPPVs) and Pharmacovigilance System Master Files (PSMFs) can still be based in the UK until the end of 2020.
  • The FDA approves first treatment for:
    • Palforzia for peanut allergies in children
    • Tepezza for the treatment of adults with thyroid eye disease
    • Tazverik for the treatment of patients aged 16 years and older with epithelioid sarcoma

Contact us for more information on how to prepare for these changes. Follow us on Twitter and LinkedIn for more updates.

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