FDA, EMA announce pilot for parallel assessment of Quality by Design applications

March 25, 2011

FDA and the European Medicines Agency have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design, of new drug marketing applications that are submitted to both agencies.

FDA 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.

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 FDA and marketing authorization applications (MAAs) submitted to the EMA. However, there will be regular communication and consultation between European regulators and their US 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 FDA assessors/reviewers to share full knowledge about these applications

• Developing and harmonizing regulatory decisions to the greatest extent possible.

“This is a very interesting continuation of other efforts moving toward international regulatory harmony that recognizes the global marketplace,” Randy Vogenberg, PhD, principal at the Institute for Integrated Healthcare in Sharon, Mass., and executive director of the Biologic Access & Finance program at The Jefferson School of Population Health in Philadelphia, told Formulary. “The voluntary pilot program-reviewers from both agencies will separately assess applications-should be welcomed by major pharmaceutical companies as it will streamline their R&D efforts as well as marketing approvals on a multicountry level.

“This effectively could shorten approval times to market as well as bolster efforts around safety and surveillance across many countries in a more synergistic fashion than currently exists,” Vogenberg added. This pilot program applies to NDAs and MAAs, some 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 biologically derived products. Review of QbD applications does not change statutory deadlines. The pilot will end on March 31, 2014.

For more information:
• European Medicines Agency, http://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp&jsenabled=true%3E2

• International Conference on Harmonization - Quality Guidance, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065005.htm

• International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4241B1-02-06-FDA-Q10%20concept%20paper.pdf