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Developments from the US Food and Drug Administration, European Medicines Agency, and other key regulatory bodies and news from key trade associations.

PTSM: Pharmaceutical Technology Sourcing and Management
Volume 3, Issue 7

Tampa, FL (July 2)The International Society for Pharmaceutical Engineering (ISPE) launched a new initiative called Product Quality Lifecycle Implementation (PQLI) at its Washington Conference held in Washington D.C. in early June.

ISPE says in its role as a "catalyst for change," the association is working with regulators in the United States, Europe, and Asia-Pacific to help industry find solutions to the challenges in implementing guidances of the International Conference on Harmonization (ICH). The goal of these sessions is to begin to define areas where industry will be able to provide the technical framework for the implementation of Quality by Design in regulatory submissions.

London (June 21)The European Medicines Agency agreed to follow up with patients affected by Roche (Basel, Switzerland)'s "Viracept" (nelfinavir), which was recalled in June. The drug, an antiretroviral medicine used to treat HIV-1 infected patients older than three years, was recalled from the European market after it was learned that some batches had become contaminated with ethyl mesilate during manufacturing. Ethyl mesilate is harmful to DNA.

The agency's Committee for Medicinal Products for Human Use (CHMP) concluded on June 13 that there were insufficient data to establish which doses of ethyl mesilate might be toxic to humans and requested that Roche carry out animal studies to calculate this level more precisely. Preliminary results are expected by the end of 2007.

CHMP also asked the company to identify the group of patients exposed to the contaminated batches of Viracept so that the committee can follow up and monitor their situation. CHMP plans to monitor all patients exposed to high levels of the contaminant in batches released since March 2007, as well as all pregnant women and children ever exposed to Viracept, including those children exposed

The agency also recommended that the European Commission suspend Viracept's marketing authorization. Until the manufacturing issues are identified by CHMP and resolved, the drug will not be available to patients.

Rockville, MD (June 18)The US Food and Drug Administration (Rockville, MD), the European Commission (EC, Brussels, Belgium), and the European Medicines Agency (EMEA, London agreed to extend cooperative activities to the areas of pediatrics and medicinal products for rare diseases (i.e., orphan drugs). These activities will include scientific dialogue on extensions of therapeutic indications and risk-management plans.

According to a prepared statement, the agreement "builds on the achievements in cooperation on vaccines, oncology, and pharmacogenomics" with the objective of "promoting and protecting public health, reducing regulatory burden and costs, and bringing innovative products to patients in a timely manner."

The European Union recently adopted legislation governing pediatric therapeutics. During a meeting with FDA in mid-June, the EU finalized its "Principles of Interactions" document, which aims to facilitate timely exchange of scientific information and ethical issues. The meeting also involved a discussion of "upstream regulatory cooperation on new medicines legislation." Although no details of this discussion were released, the agencies announced plans to hold a meeting on a "Transatlantic Workshop on Administrative Simplification in Medicines in Regulation" on November 28 in Brussels.

Washington, DC (June 19)—The House Subcommittee on Health voted to forward the amendments to the Prescription Drug User Fee Act to the House Committee on Energy and Commerce. The bill was altered slightly in committee. Langauge that would have eliminated the US Food and Drug Administration's (Rockville, MD) preemption authority over state laws was removed, as was a provision limiting exclusivity to six months for all drugmakers


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