EU Aims For U.S., EU Regulatory Harmonization on Approval, Guidelines and GMP

The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, 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.

The annex asks U.S. and EU regulatory agencies to collaboratively develop guidelines for drug approvals and pre-approval inspections.

Additionally, the agencies should adopt all guidelines from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, the EU said.

The guidelines should standardize requirements for drug approval regarding quality, safety, efficacy and, when applicable, preclinical and clinical data. The agencies could then reach agreements on regulatory designations for particular drug products, such as breakthrough and orphan drugs.

As part of the proposed annex, the EU recommends the agencies discuss generics, biosimilars and medicinal products that address unmet needs.

Further, the annex calls on the agencies to share:

• Legislative and guidance documents for drug products;
• Information from sponsor applications for scientific advice, orphan designations, approvals and post-marketing activities;
• Pharmacovigilance data;
• GMP and GCP inspections and reports; and
• Information on GMP non-compliance, recalls, data integrity drug shortages.

Collaboration between agencies should encourage the development of rapid diagnostics, alternative treatments and new anti-microbials.

Stay up to date on regulatory stories like this one by subscribing to the Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA’s interpretation and enforcement of GMPs and the Quality Systems Regulation — information you need to stay in compliance.