European Medicines Agency and US Food and Drug Administration announce pilot programme for parallel assessment of quality-by-design applications

Press release 16/03/2011

Pilot to start as of 1 April 2011

The European Medicines Agency (EMA) and the United States (US) Food and Drug Administration (FDA) are launching a three-year pilot programme that will allow parallel evaluation of relevant quality data components, known as quality by design (QbD), of selected applications that are submitted to both agencies at the same time. The pilot will be starting on 1 April 2011.

QbD in pharmaceuticals involves an enhanced systematic and science-based approach to development and manufacturing, to better ensure product quality. Several guidelines and question-and-answer documents have been developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in order to facilitate the implementation of QbD. Taking into account the global perspective of pharmaceutical manufacturing, and to facilitate the harmonised implementation of the ICH concepts, the EMA and FDA agreed that experts from both agencies should exchange their views using real applications.

Under this programme, both agencies will assess the parts of the applications relevant to QbD, such as development, design space and real-time release testing. The evaluation will be performed separately by each agency, with regular communication and consultation throughout the review, with the aim of having a common list of questions to the applicants and a harmonised evaluation of their responses.

In Europe, this pilot applies to new marketing-authorisation applications and quality-related scientific-advice requests. Type-II variations may be included on a case-by-case basis. In the US, the programme will cover new drug marketing applications (NDAs), prior-approval supplements (sNDAs) and chemistry-manufacturing-control meeting requests. The pilot programme will only include chemical entities. However, ongoing consideration will be given to other areas of collaboration.

Participation in the pilot is voluntary, and interested applicants and sponsors are asked to notify both agencies three months prior to submission of an application. The notification should include a brief description of the QbD elements in the application and expected submission dates. This pilot will conclude on 31 March 2014. Both agencies will jointly assess and publish the outcome of this pilot programme.

Note

  • The pilot program will operate under the European Union (EU)-US confidentiality arrangements and within the framework of the EU-US Bilateral Technical Working Group on Medicines Quality and Manufacturing.

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