The European Medicines Agency will require all products to have one review five years after marketing authorization, effective Nov. 20, 2005.

"We have changes which will have an impact on the validity of the market authorization, where after the first review, after five years, we may not need to have any other renewal after that," EMEA Quality of Medicines Head of Sector John Purves said Jan. 10 at a California Separation Science Society-sponsored meeting in Washington, D.C.

EMEA previously required that marketing authorization be renewed every five years. The agency decided to revise that requirement, Purves said, during a renewal process for its regulations.

"It was agreed when the European agency was set up in 1995 that what we should do after a period of about five or six years is review how effective the system is working, and as a result of that, we've had quite a few changes in registration between then and now," he said.

"Previous experience has shown that that was a heavy procedure and it's one that was probably better handled by post-authorization commitments," Purves explained.

"The term of validity of a Community marketing authorization should be limited initially to a period of five years, upon the expiry of which it should be renewed," the ¹ regulation states. "Thereafter the marketing authorization should normally be of unlimited validity."

The March 31, 2004 reg was published in the April 30, 2004 issue of the Official Journal of the European Union.

EMEA will continue to survey a product's safety after its renewal through adverse event reports and periodic safety update reports, more in line with FDA's method. EMEA also monitors drug safety through AER and PSURs prior to the five-year renewal.

Products approved prior to the regulation's effective date will undergo one additional marketing renewal. For example, a product approved in 1998, which would have had one review for renewal in 2003, will be required to pass muster once more before 2008.

EMEA can request one additional five-year renewal if the circumstances warrant, the regulation stipulates.

"Once renewed, the marketing authorization shall be valid for an unlimited period, unless the Commission decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal."

Six months ahead of EMEA's renewal review of a product, the marketing authorization holder should provide the agency "with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since the marketing authorization was granted."

Authorization for products that have not been marketed for three consecutive years shall be invalidated, the regulation states, "in order...to avoid the administrative burden of maintaining such authorization."

EMEA's revised requirements could provide a model for future changes to FDA's post-marketing surveillance. There have been calls for FDA to take up EMEA's old process of product renewal every five years (² [A#00660480007], p. 12).

Post-marketing requirements that combine attributes from both agencies' previous practices might be more palatable to FDA than renewing each product's approval every five years.

Global parity in regards to adverse events reporting availability for patients appears to be on the horizon.

FDA recently began publishing raw adverse event report data on a quarterly basis. The ³ AERS quarterly files are located at www.fda.gov/cder/aers/extract.htm.

The U.K.'s Medicines & Healthcare products Regulatory Agency also is opening its adverse events reporting system to patients.

A complete list of suspected adverse drug reactions that are reported through the adverse event reporting system will be provided on the website for MHRA's adverse event reporting system - the Yellow Card scheme.

EMEA is also making efforts to publish its adverse event data, creating a committee to devise the best way to disseminate the information.

EMEA Refines Post-Market Renewal Requirements To One Five-Year Review

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