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:

  • A table with the access rules for EMA corporate documents
  • A revised table with the access rules for documents related to human and veterinary drugs held by EMA: Output of the EMA policy on access to documents related to medicinal products for human and veterinary use.

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

By Zachary Brennan