FDA and EMA co-operate on drug reviews

The US Food and Drug Administration (FDA) has announced a pilot partnership programme with the European Medicines Agency (EMA) intended to help ensure consistent implementation of certain guidelines when reviewing marketing applications for new drugs. The co-operative effort between the FDA and the European Medicines Agency (EMA) will allow parallel evaluation of certain components of new drug marketing applications that are submitted to both agencies.

Under the voluntary pilot programme, there will be regular communication and consultation between the two sets of regulators during the assessment of the portions of the applications related to Quality by Design (QbD), which involves the design and development of formulations and manufacturing processes to help ensure product manufacturing quality.

The pilot project is intended to address the concern that some guidelines related to QbD developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) have thus far been interpreted differently by the FDA and the EMA. Reviewers from the FDA and EMA will continue to engage in separate assessments of the quality/chemistry, manufacturing and control (CMC) section of the drug applications.

Goals of the pilot project, which runs through the end of March 2014, include: increasing awareness of regulatory concepts by staff that review applications and inspect manufacturing facilities as part of the approval process; defining the reviewer and inspector interaction for QbD applications; creating a further way for EMA and FDA assessors/reviewers to share full knowledge about applications; and developing and harmonising regulatory decisions to the greatest extent possible.

In addition to marketing applications for new drugs, the pilot programme will extend to some supplements and CMC meeting requests that include QbD elements and are submitted to both agencies roughly simultaneously. The programme will only involve chemical entities, and not biologically derived products.

"This is another concrete example of the very collaborative working relationship we have with our European regulatory colleagues and how we can leverage the scientific resources we both have for the benefit of our agencies and our citizens," said Murray M Lumpkin, deputy commissioner of FDA's Office of International Programs.

In September 2010, the two agencies said they would indefinitely extend confidentiality arrangements covering issues related to medicinal products for human and veterinary use.