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Providing the latest business, scientific, and regulatory news for the pharmaceutical and biotech industries.
News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
In The Field
US and China Crack Down on Regulation after SFDA Chief Executed
The People's Republic of China executed one of its former drug safety chiefs, Zheng Xiaoyu, on July 11, 2007, for taking bribes to approve untested pharmaceuticals, including some medicines that contained fake ingredients and led to several deaths. Zheng, who led China's State Food and Drug Administration (SFDA) from 1998 to 2005, was charged and sentenced for taking an estimated 6.5 million yuan, or $850,000, in bribes to pass a number of new pharmaceuticals through the system.
On the day of Zheng's execution, the Chinese government released a more strict set of drug registration regulations for officials in an effort to close a number of loopholes in the system. According to an SFDA news release, the agency also revoked the production licenses of five drug manufacturers and three factories in the past year and withdrew good manufacturing practice certificates from 128 drugmakers. An ongoing component of the country's food and drug regulation cleanup includes a review of some 170,000 SFDA-issued medicine production licenses, many of which were approved during Zheng's tenure.
"Some applicants' research documentation has been substandard, there have been serious problems with fraud and fakery, and it's been nigh impossible to ensure pharmaceutical safety," said Wu Zhen, deputy head of SFDA, at a July 11 news briefing.
A US delegation of health officials visited China in early August on a fact-finding mission regarding food and drug safety issues. The mission was meant to spark discussions in an effort to create bilateral agreements on food and feed safety, as well as on drug and medical device safety by the year's end, according to a July 30 statement from the US Department of Health and Human Services (HHS).
Specifically, said HHS Secretary Mike Leavitt, the US is looking to attain three things: "better cooperation," "better information," and "to have the Chinese devise and enforce regulations that we can understand, with which we agree, and in which we feel confident."
The result of these and future meetings between US and Chinese representatives will be included in the recommendations of
the US Working Group on Import Safety, chaired by Leavitt, to be presented to President George W. Bush this September.
Xcellerex Receives US Grant for Biopharmaceutical Production
Xcellerex, Inc., based in Marlboro, Massachusetts, received two Phase-I contracts from the Defense Advanced Research Projects Agency for the Accelerated Manufacture of Pharmaceuticals (AMP) program on July 17.
The AMP program is a three-phase program in which the US military is focused on technologies for producing emergency therapeutics and vaccines. Total funding for the two Phase-I contracts is more than $13 million.
Xcellerex will serve as the prime contractor on the first grant, in which the company is collaborating with Dowpharma (Midland, MI), a business unit of The Dow Chemical Company, Biopharm Services (Marlboro, MA), and deltaDOT, Ltd. (London).
On the second contract, Xcellerex is collaborating with Neugenesis Corp. (Burlingame, CA) as the prime contractor, SRI International
(Menlo Park, CA), and BioPharm Services. The grant is based on the use of Xcellerex "PDMax" and "FlexFactory" technologies
to show the potential of Neugenesis's "NeuBIOS" protein-production platform. Neugenesis and SRI will provide project management
and integration systems for the team.
New FDA Guidance on Polymorphic Compounds in Generic Drugs
A new guidance issued by the US Food and Drug Administration on July 9, advises companies on how to treat polymorphic drug compounds—those that exhibit multiple structural forms—in filing abbreviated new drug applications (ANDAs). The bottom line, according to the guidance, is that generic drug products containing the polymorphs be the "same" as the reference listed drug (RLD) in active ingredients, bioavailability, and bioequivalence. The guidance pertains to orally available drugs that are either solid- or suspension-dosage products.
The guidance also emphasizes the effect polymorphisms may have on drug stability, which again, may alter the drug's biological
activity. But the guidance goes on to say that "it is the stability of the drug product and not stability of the drug substance
polymorphic form that should be the most relevant measure of drug equality." Otherwise, a generic drug can be considered the
"same" as the active ingredient in an RLD if the generic compound conforms to the standards set out in a United States Pharmacopeia
(USP) monograph, if one exists for that particular drug substance. These standards generally include the chemical name, empirical
formula, and molecular structure of the compound. However, the "FDA may prescribe additional standards that are material to
the sameness of a drug substance." But as concerns polymorphisms, the guidance goes on to say "...differences in drug substance
polymorphic forms do not render drug substances different active ingredients for the purposes of ANDA approvals...." Finally,
the guidance reminds ANDA applicants that the biological performance characteristics of a drug are also dependent on the drug's
formulation and advises applicants to consider the properties of both the drug substance and formulation excipients, when
Comment Periods Open for ICH Q10 and Biologics Guidelines
The US Food and Drug Administration announced in mid-July the International Conference on Harmonization (ICH) draft guidance Q10 Pharmaceutical Quality System in the Federal Register (Docket 2007D-0266, CDER 200783). The ICH Q10 draft guideline, which is open for public comment until Oct. 11, describes one approach for "an effective pharmaceutical quality system that is based on ISO concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH Q8 'Pharmaceutical Development' and Q9 'Quality Risk Management.'" The guideline, which is optional, applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.
Primary topics covered in the document include reporting and recordkeeping responsibilities relating to these arrangements
for the licensed manufacturer, contract manufacturer, and final-product manufacturer.