FDA and EMA Publish Assessment of QbD for Marketing Applications - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA and EMA Publish Assessment of QbD for Marketing Applications


FDA and the European Medicines Agency (EMA) have published a joint assessment of quality-by-design (QbD) elements of a marketing authorization application. The joint-published document answers questions on regulatory submissions for quality target product profiles, expectations for critical quality attributes, and classification of criticality for process parameters. The assessment also answers questions in regards to the application of ICH Q8 (R2).

The assessment is the result of a pilot program launched by FDA and EMA in March 2011. The pilot program allows the two agencies to share review findings throughout the review process about QbD elements of applications that were chosen for the pilot. The assessment gives the agency the opportunity to collaborate on regulatory decisions so that quality of pharmaceutical products is consistent in the US and Europe. Experts from the Japanese Pharmaceuticals Medical Device Agency observed the first parallel assessment. FDA and EMA will publish further outcomes of the pilot as more assessments are conducted.

Source: FDA.gov

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests

Click here