Regulatory updates September 2006

Europe
- draft guideline on virus safety evaluation of biotechnological investigational medicinal products
- guideline on the limits of genotoxic impurities
- emea pre-submission guidance for users of the centralized procedure
- emea post-authorization guidance for users of the centralized procedure
- pic updated gmp guide
 
USA
- frequently asked questions about biologics
- requirements for foreign and domestic establishment registration and listing for human drugs
- fda’s discussion with who on inn policies for biosimilars
- guidance for industry: compliance with 21 cfr part 1271.150(c)(1) - manufacturing arrangements submitting electronic documents to cber

Australia
- guidelines on sterility testing of therapeutic goods

China
- medical devices with bovine/ovine products

ICH
- briefing slides for q9
- ichq4b: regulatory acceptance of analytical procedures and/or acceptance criteria

Slide Presentations
- Workshop - CGMP By the Sea

Upcoming meeting
- U.S. FDA Regulated Products Containing Nanotechnology Materials

For more information please download the document on Regulatory updates web page