Industry News Industry News EFPIA Backs Move Towards Full Clinical Data TransparencyDate: 09-06-2011 -- PharmaTimes (09/06/11) Mansell, Peterbody: The European Federation of Pharmaceutical Industries and Associations (EFPIA) thinks that in future virtually all data from relevant clinical trials should be disclosed once a new medicine receives approval for marketing, although EFPIA director general Richard Bergstrom conceded that there will be information on patients and individuals that needs to be shielded. EFPIA made its position clear in a response to a draft guidance document presented for consultation by the European Medicines Agency and the Heads of Medicines Agencies several months ago. The agencies were especially interested in comments on proposed criteria for the issuance or protection of personal data; whether contractual agreements between companies needed to be maintained as confidential; and how to deal with the personal security of individuals participating in animal studies. EFPIA suggests that enhanced transparency not only dovetails with the broader goal of promoting and protecting public health, but also is "essential in maintaining overall public trust and confidence in the system for the regulation of medicines in Europe." The association thinks three core issues need to be settled before the routine public disclosure of marketing authorization (MA) dossiers. EFPIA cautions that publishing clinical study reports at the time of MA "may be regarded as 'prior publication,' such that scientific journals will not accept or put on hold journal manuscripts." A second issue is that the publication of "certain CMC [chemistry, manufacturing and controls] and non-clinical data following EU approval could enhance the ability of non-innovators to obtain approval outside the EU based on the originator's data." The third concern for EFPIA is that issuing "a vast amount" of clinical data in this way raises the bar for regulatory agencies to ensure that current versions of the data are publicized.URL: http://www.pharmatimes.com/Article/11-09-06/EFPIA_backs_move_towards_full_clinical_data_transparency.aspx