FDA and EMA join forces on quality-by-design
pharmafile | March 22, 2011 | News story | Manufacturing and Production |Â Â EMA, FDA, QbD, Quality by Design, pharmaceutical marketing applicationsÂ
The FDA has teamed up with the EMA on a new pilot programme that will allow parallel evaluation of marketing applications incorporating elements of quality-by-design (QbD) from 1 April.
QbD is a concept in which the quality aspects of a production process and the resulting product are intended to be built-in from the start, based on a clear understanding of the process and the use of a well-defined risk-management strategy.
The basic tenets of QbD are laid out in the ICH Q8, Q9 and Q10 documents developed by the International Conference on Harmonization.
“This pilot programme began out of concern that certain ICH guidelines were being interpreted differently in Europe and the USA,” said the two agencies in a joint statement.
The FDA and EMA have making an effort to bring their activities closer into line in recent years, notably via their joint manufacturing facility inspection pilots for finished products and active pharmaceutical ingredients (APIs).
The three-year pilot will involve the parallel review of relevant development and manufacturing data components, particularly the quality/chemistry, manufacturing and control (CMC) section of marketing applications submitted to the FDA and EMA.
There will be regular communication and consultation between European regulators and their US counterparts throughout the review period.
“As the number of applications that follow the QbD approach steadily increases, collaborative assessments will enhance understanding of QbD concepts,” commented Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, at an event to launch the initiative last week.
“To fully implement QbD, we need to further harmonise the implementation of the guidelines, work collaboratively, and provide scientific, risk-based regulatory decisions in a timely manner”, she added.
Among the goals of the pilot programme are ensuring consistent implementation of ICH guidelines for manufacturing quality in the application evaluation process; increasing awareness of these regulatory concepts by agency staff; defining the reviewer and inspector interaction for QbD applications; and developing and harmonising regulatory decisions to the greatest extent possible.
The pilot program applies to New Drug Applications and Marketing Authorisation Applications, some dietary supplements, and CMC meeting requests that include QbD elements submitted to both agencies at about the same time.
The pilot will only include chemical entities and not biologic products and is scheduled to end on March 31, 2014.
Phil Taylor
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