EMA Report: Clinical Data Published on 50 Medicines in One Year

Regulatory NewsRegulatory News | 16 July 2018 |  By 

The European Medicines Agency (EMA) on Monday published its first report on implementing its policy on the publication of clinical data whereby researchers, academics and others can access data from clinical reports submitted by pharmaceutical companies to EMA for new medicines as of 1 January 2015.

The 27-page report covers one year from the launch of EMA’s clinical data website on 20 October 2016, and lists the 50 medicines for which clinical data were published, including orphan (9), pediatric (6), biosimilar (1) and generic (12) medicines, as well as the corresponding 54 regulatory dossiers.

The data have attracted a total of 3,641 users, resulting in 22,164 document views and 80,537 downloads for non-commercial research purposes, EMA said. The regulator published an average of six dossiers a month in the period from October 2017 to May 2018, reaching the 100th published dossier milestone on 29 May 2018.

EMA is the only regulatory authority to provide open access to clinical data submitted by companies in support of their marketing authorisation applications (MAAs).

Confidential Info

The report unveils the documents published, the amount of commercially confidential information (CCI) redacted and the anonymization techniques used.

EMA accepted about one third (33% or 48 of 145 documents) of CCI redactions proposed by pharmaceutical companies, though only 0.01% of 1.3 million pages published contained CCI redactions. Reasons for rejecting CCI included that certain information was already in the public domain or there was insufficient justification, among others. Detailed analytical methods or assays were often accepted as CCI.

As far as anonymization techniques to protect personal data, the report suggests conducting a “proper assessment” of the impact of the anonymization technique on data utility and improving the quality of the anonymization reports, EMA said.

Also in the report: The results of a user survey of the clinical data website finding 62% of users were affiliated to the pharmaceutical industry, 14% to academia, 8% were patients and 8% healthcare professionals.

As EMA prepares for its relocation to the Netherlands, the publication of clinical data will be affected as of the second half of 2018 and in 2019.

“The Agency will do its utmost to resume this activity to the level outlined at the start of the policy once the relocation is complete,” EMA said.

Policy on the publication of clinical data (Policy 0070)


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