Regulatory Roundup: Senate Confirms Collins NIH Head, More...

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, EMEA gives public access to GMP data; SOCMA speaks out on toxic substances; more...

The Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice-President Ken Johnson issued a statement regarding PhRMA’s support for Senate introduction of the Customs Facilitation and Trade Enforcement Reauthorization Act of 2009. Johnson praised the act’s efforts to “strengthen IP [intellectual property] rights enforcement, improve trade facilitation, modernize the customs service and ensure import safety.”

The European Medicines Agency (EMEA) posted a public statement in which it announced the timeline for the withdrawl of the marketing authorization for the psoriasis drug Raptiva (efalizumab). In April 2009, Roche and Genentech announced a phased voluntary withdrawal of Raptiva from the US market because of the drug’s association with an increased risk of progressive multifocal leukoencephalopathy, a rare and usually fatal disease of the central nervous system.

The European Medicines Agency (EMEA) is now providing public access to information about manufacturing and importation authorizations and good manufacturing practice (GMP) certificates through the website EudraGMP. The EudraGMP database was initially launched in April 2007 to facilitate the exchange of information on compliance with GMP among the competent regulatory authorities within the European medicines network. The decision to make the information available to the public came from a drive for more openness and transparency, according to an EMEA press release.


The Society of Chemical Manufacturers and Affiliates (SOCMA) called on Congress to update the decades-old Toxic Substances Control Act (TSCA) chemical-management regulation without enacting a complete overhaul. The organization believes this would be unduly burdensome to its membership, many of whom are small and mid-sized companies. “Sweeping regulatory overhaul at this time could have disastrous consequences,” said SOCMA President Joe Acker in a press release. SOCMA is the US-based trade association representing custom and batch manufacturers, including contract manufacturers of active pharmaceutical ingredients and intermediates.

Last week, the Senate confirmed Francis S. Collins as head of the National Institutes of Health. Collins previously led the Human Genome Project and served as director of the National Human Genome Research Institute at the National Institutes of Health from 1993-2008. He was nominated by President Obama in July.