SILVER SPRING, Md., March 16, 2011 /PRNewswire-USNewswire/ —
The U.S. Food and Drug Administration and the European Medicines
Agency (EMA) have launched a new pilot program that will allow
parallel evaluation of relevant development and manufacturing data
components, known as Quality by Design (QbD), of new drug marketing
applications that are submitted to both agencies.
(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)
The parallel evaluation within this voluntary pilot program
means that reviewers from both agencies will separately assess the
quality/chemistry, manufacturing and control (CMC) section of the
new drug applications (NDAs) submitted to the FDA and marketing
authorization applications (MAAs) submitted to the EMA.
However, there will be regular communication and consultation
between European regulators and their U.S. colleagues throughout
the review process relevant to QbD aspects of the applications.
QbD in pharmaceuticals involves designing and developing
pharmaceutical formulations and manufacturing processes to help
ensure product manufacturing quality. Several guidelines have been
developed by the International Conference on Harmonisation (ICH) to
harmonize and facilitate the implementation of QbD. This pilot
program began out of concern that certain ICH guidelines were being
interpreted differently in Europe and the United States. Goals of
the pilot program include:
- Helping to ensuring consistent implementation of ICH guidelines
for manufacturing quality in the application evaluation
process - Increasing awareness of these regulatory concepts by staff that
review marketing 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 FD
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