Regulatory Roundup, Week of November 26, 2012 - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Regulatory Roundup, Week of November 26, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency (EMA) has announced a plan to address drug supply shortages following manufacturing problems. The plan was developed in collaboration with the European regulatory authorities in the EU member states.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has provided an update from the Pharmacopoeial Discussion Group (European Pharmacopoeia, Japanese Pharmacopoeia, and the US Pharmacopeia) meeting that took place on Nov. 6–7, 2012 in Rockville, Maryland. According to EDQM, 28 of the 35 General Chapters and 43 of the 62 excipient monographs have been harmonized.

The International Conference on Harmonization (ICH) has released an update from the Steering Committee and its Expert Working Groups meeting in San Diego, California, on Nov. 10–15, 2012. The meeting addressed reform to include the involvement of global regulators and reassure ICH’s commitment to harmonization.

FDA has released the following guidance documents and guidelines:

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
20%
Attracting a skilled workforce
28%
Obtaining/maintaining adequate financing
12%
Regulatory compliance
40%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here