EU: Align U.S. and EU Requirements on Approval, Guidelines and GMP

The European Union wants to expand ongoing trade talks between the U.S. and EU to work toward regulatory harmonization for drug approvals, guidelines and GMP compliance.

The EU recommends the FDA and EMA accept one another’s GMP compliance certificates for manufacturing facilities located in and outside of their respective jurisdictions and suggests U.S. and EU regulators eliminate duplicate clinical trial and GMP inspection requirements by synchronizing rules.

The proposal is being presented as a new annex on medicinal products to be discussed at the Transatlantic Trade and Investment Partnership talks.