Transparency Push: EMA to Revise Policy on Document Access

Posted 17 February 2017 By Zachary Brennan

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The European Medicines Agency (EMA) on Friday proposed a revision to its policy on accessing documents, extending the scope to include corporate documents, and increasing the publication of clinical data for pharmaceuticals.

Since October 2016, EMA has published pharmaceutical trial data via its new website, including for: Mylan's aripiprazole, published most recently on 31 January 2017, Pfizer subsidiary Hospira's palonosetron, Praxbind (idarucizumab), Tarceva (erlotinib), Armisarte (pemetrexed diacid monohydrate), Caspofungin Accord (caspofungin acetate), Kyprolis (carfilzomib) and Zurampic (lesinurad).

EMA is now seeking comments until 18 May on a revision that says: “The information proactively published will be increased with the introduction of proactive publication of clinical data for medicinal products for human use (EMA Policy/0070) and with the coming into force of other relevant legislative provisions.” EMA may establish “other rules regarding the publication of documents” to ensure transparency in accordance with Article 80 of Regulation (EC) No 726/2004.

EMA’s management board in October also gave the go-ahead for a new European medicines web portal, which will look to provide wider access to free, reliable and unbiased information on all medicines authorized in the EU.

The revised policy unveiled Friday details how EMA grants access to its own documents, in accordance with Regulation (EC) No 1049/2001. Other parts include:

In addition, there’s a new classification of documents as either “releasable” or “non-releasable” (previously, documents were classified as "public" and "confidential"), as well as more clarity on when documents become releasable and a new section on the level of information made available for requesters.

Revised policy on access to documents

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Categories: Biologics and biotechnology, Drugs, Clinical, Due Diligence, Government affairs, News, Europe, EMA, EC

Tags: pharmaceutical data transparency, EMA transparency

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