Excipient Control Strategies in China - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Excipient Control Strategies in China
As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.


CPhI Focus: Pharmaceutical Ingredients


The ongoing collaboration of industry groups such as IPEC with SFDA and FDA will effectively provide appropriate excipient controls that benefit the consumer by improving drug safety and quality. This collaboration and dialogue will also ensure that new regulatory requirements are reasonable and do not create non-value-added costs in the system that would unnecessarily increase drug prices without providing any further improvements in safety to the consumer.

David R. Schoneker is chairman of the International Pharmaceutical Excipients Council of the Americas. He also is director of global regulatory affairs at Colorcon, 1936 West Point Pike, West Point, PA 19486, tel. 215.699.7733,
.


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
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
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
Source: CPhI Focus: Pharmaceutical Ingredients,
Click here