OR WAIT null SECS
© 2023 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
The EMA press release issued states: "According to the policy?s terms of use, the public can either browse or search the data on screen, or download, print and save the information. The reports cannot be used for commercial purposes. In general, the clinical reports do not contain commercially confidential information.
The EMA announced it will publish clinical reports, and that requirement will be begin January 1, 2015. EMA expects the new policy to increase trust in its regulatory work as it will allow the general public to better understand the Agency’s decision-making. In addition, academics and researchers will be able to re-assess data sets. The publication of clinical reports will also help to avoid duplication of clinical trials, foster innovation and encourage development of new medicines.
The EMA press release issued states: "According to the policy’s terms of use, the public can either browse or search the data on screen, or download, print and save the information. The reports cannot be used for commercial purposes. In general, the clinical reports do not contain commercially confidential information. Information that, in limited instances, may be considered commercially confidential will be redacted. The redaction will be made in accordance with principles outlined in the policy’s annexes. The decision on such redactions lies with the Agency."
Further, in a Q&A on the topic, the EMA will implement the policy in a stepwise approach as follows:
The full draft is available on the EMA site.