OPEN Pilot: One-year Review and Recommendations

7 July 2022 — EMA published the OPEN Pilot report.

The pilot phase of the OPEN Initiative (Opening our Procedures at EMA to Non-EU authorities) is intended to run for the duration of the declared COVID-19 pandemic. Regulators from Australia, Canada, Japan, Switzerland and the World Health Organization participate in the pilot under the terms of existing confidentiality arrangements. These non-EU experts are invited to attend and contribute to ETF and CHMP evaluations and discussions for COVID-19 vaccines and therapeutics. All regulators keep full scientific and regulatory independence in their final decision making.

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