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DRUG REGULATION
European Union health ministers gave preliminary approval to centralized drug review regulations that would make new pharmaceutical approvals possible in under a year. The new rules, which the European Parliament is expected to approve by December, is a step toward the creation of a single EU drug agency with broad powers similar to the U.S. FDA.
Under the rules, the European Medicines Evaluation Agency's (EMEA) authority would expand to cover new drug applications for cancer, AIDS, neurodegenerative diseases, and diabetes. Other types of drugs could continue to gain approval through the London-based EMEA or member state health agencies. Up to now, only biotechnology drugs had to be approved through EMEA, established in 1995. Drugmakers whose medicines must follow the centralized review process would have exclusive rights to data generated on new drugs for 10 years plus one additional year for an alternative use. That is an improvement over the six to 10 years of EU intellectual property protection a drug firm now receives, depending on which member state reviews and approves a new drug application. However, a spokesman for the European Federation of Pharmaceutical Industries & Associations said it was "illogical" to provide less protection to drugs that did not have to follow the centralized approval procedures. A provision in the new rules would allow generic drugmakers access to drug data in the eighth year following approval so they could be ready with cheaper versions as soon as the 10 years of protection expired. |
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