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insights LIFESCIENCELEADER.COM APRIL 2014 48 or the 30 to 40 percent of organizations still struggling with initial electronic sub- missions, the new demands will be a bitter pill to swallow. To sweet- en the transition, companies should look for the additional efficiency benefits that are possible once they have their data management ailments under control. Following much anticipation, in late January 2014 the European Medicines Agency (EMA) finally issued expected guidelines on how to update/main- tain data submitted to the extended EudraVigilance Medicinal Product Dictionary (XEVMPD). This aims to cata- log all human drug products marketed in EU countries. The requirements come under Article 57(2), the official EU leg- islation that brought about the require- ment for the XEVMPD database. Any life sciences company distribut- ing products in Europe had a mandate to submit complete product informa- tion and documentation to this central electronic database by July 2012. But to give the agency a chance to absorb and organize all of this content, compa- nies were asked not to submit updates to this initial information until new guidelines had been issued on the pro- cess and timescales for ongoing data REGULATORY COMPLIANCE code, from a consolidated and cleaned- up list, to ensure it is correctly cat- egorized as herbal, pharmaceutical, etc. Finally, an authorized pharmaceutical form covering the dosage of products must be included. MAKING UP FOR LOST TIME The agency is proposing a transition phase, between June and December of this year, during which marketing authorization holders are expected to bring their product data up to date and improve the quality of the data they have already submitted. But, however pre- pared companies feel, this won't be easy. As organizations prepare to respond to the new requirements, they will need to take stock of where they are today and how far they still have to go before they are able to meet the latest XEVMPD requirements reliably and as painlessly as possible. A conservative estimate based on our regular contact with pharma companies suggests that 30 to 40 percent of affected organizations have yet to finish their original submissions, so they do not yet even have a complete data set registered with the XEVMPD. Worse still, many firms had shelved XEVMPD initiatives while the new guidelines were being con- maintenance. That guidance has now been published, putting pharma organi- zations under new pressure to respond and get their submitted information up to date. THE NEW DIAGNOSIS It had been expected that ALL changes to marketing authorizations would have to be made within as short a time frame as 15 days; however, according to the issued guidelines, the 15-day period will only apply to new marketing authoriza- tions. Updates to existing submissions will have a 30-day window, but even that is hardly any time, given the sheer vol- ume of product files that will be affected. Those firms that had been diligent in submitting their original product information well ahead of time will be dismayed to learn that updates will be required across almost all content — because new data fields have now been introduced. For instance, the agency now requires that companies indicate the size of their operations, i.e., whether they are small, medium, or large organizations. They must also provide information about the legal basis of the marketing authorization for each submission — i.e., which act they are applying under. Then they must apply the right product Are You Prepared For The New European Pharmacovigilance Guidelines? M I R A N D A P O T H I A W A L A EVMPD (EudraVigilance Medicinal Product Dictionary) requirements have moved back up the agenda for pharma companies marketing products in Europe, now that new requirements on data maintenance have finally been published. F By M. Pothiawala ARE YOU PREPARED FOR THE NEW EUROPEAN PHARMACOVIGILANCE GUIDELINES? 0 4 1 4 _ R e g u l a t o r y . i n d d 1 0414_Regulatory.indd 1 3 / 2 1 / 2 0 1 4 1 2 : 1 9 : 0 4 P M 3/21/2014 12:19:04 PM