Regulatory Roundup: Week of July 16, 2012 - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Regulatory Roundup: Week of July 16, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA has indicated it is moving forward with a long-planned pilot to test ways to ensure the quality and integrity of imported pharmaceutical ingredients and finished products. The Secure Supply Chain Pilot Program was originally proposed in 2009 but generated concerns about excessive red tape and oversight. FDA has revised the program and is seeking final approval from the Office of Management and Budget to move forward. FDA’s plan is to select up to 100 manufacturers and importers that each submit information on how five drugs will be imported into the US. Applicants must maintain records documenting the product’s movement through their secure supply chain, meet customs requirements to guard against terrorism, and demonstrate that they comply with good importer practices proposed by FDA. Jill Wechsler covers this topic in the August 2012 issue of PharmTech.

The European Medicines Agency is opening up its new pharmacovigilance legislation (EU No 1235/2010, Directive 2010/84/EU) for public consultation through Aug. 17, 2012. The legislation requires manufacturers to provide healthcare professionals with a summary of product characteristics that includes a statement and black symbol for drugs that are under additional monitoring for safety issues. Changes to patient information include the addition of a statement in the package leaflet encouraging patients and doctors to report to the national reporting system any possible side effects of the product that the patient experiences.

The Biologics & Biotechnology Monographs 1 Expert Committee of the United States Pharmacopeia (USP) is asking biotechnology companies with FDA-approved and validated bioidentity methods to participate in the USP’s modernization and verification of a new bioidentity test of Somatropin drug substances and products. USP plans to move the new test into a new USP chapter, General Chapter <126> Somatropin Bioidentity Tests. More information can be found on USP’s website.

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
30%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
30%
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