Regulatory Roundup: Week of July 16, 2012

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.