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

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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.


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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
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
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Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
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