INDUSTRY CALLS FOR FASTER GENERIC DRUG APPROVALS

Generic drug firms operating in the European Union (EU) should work closely with state agencies to mitigate drug approval delays caused by bureaucratic overload, the European Generic medicines Association (EGA) said at an industry conference.

Generic drug companies in the EU have access to an expedited drug approval process due to a decentralized procedure introduced two years ago that gives member nations the authority to conduct generic drug application assessments at an early stage in the process. But the lack of available resources may be causing an atmosphere of apprehension among states willing to participate, but not necessarily able to, according to EGA Director Greg Perry.

"While we are happy with the new system, the medicines agencies are obviously struggling to run the [decentralized procedure] under a serious lack of resources," Perry said.

Only nine of 27 member states have agreed to participate in the program, and it can take up to one year before a selected nation is confirmed. One way to address this concern is to have state agencies work alongside the generic drug industry in key areas such as pharmacovigilance assessments to avoid the repetition of such tasks, Perry recommended. He also called on federal officials to eliminate certain specific national requirements in support of a more harmonized EU approach.