Thank you Dr.Darshan Bhatt for providing reference.
Here is the Concept Paper for the DSUR:
Development Safety Update Report
Type of Harmonization Action Proposed
It is proposed that ICH develop a guideline on periodic reporting of safety information from clinical trials. This guideline would define the preferred content, format, and timing of such reports. The CIOMS VI Working Group referred to this type of report as a Development Safety Update Report (DSUR). The DSUR would be used by industry to regularly inform appropriate stakeholders of new safety data and the evolving safety profile of drugs, vaccines, and therapeutic biologic products before they are marketed, and also when new indications, formulations, etc. are being studied for marketed products. The objective of the proposed DSUR for clinical trials would be similar to that of the Periodic Safety Update Report (PSUR) that is commonly used for marketed pharmaceutical products.
Statement of the Perceived Problem
Until recently, very few countries required periodic reports on investigational compounds. The US FDA has required IND Annual Reports for quite some time, but this report is a general update on the progress of the clinical development program, and is not focused strictly on safety. The recently implemented EU Clinical Trial Directive also requires an Annual Safety Report, but its content, format, and timing are quite different than that required by FDA. As the provisions of the Clinical Trial Directive are being incorporated into regulation by each Member State, it is becoming obvious that interpretation of its provisions varies among regulatory authorities, and different regulators are requiring different report formats, content, and/or timeframes for the same compounds. This not only leads to a duplication of effort on the part of study sponsors, but could also lead to inconsistency in the information each regulatory authority receives regarding the safety of the investigational compounds. In addition, even where there is a single standard for the content of periodic reports, such as in the US, the information provided varies considerably from one sponsor to another.
Since most global companies conduct multi-country studies during product development, a standard safety report with defined content, format, and timing would improve the business efficiency of both industry and regulators. An ICH Guideline on DSURs would serve to define expectations for these reports; provide practical and useful guidance regarding provision of meaningful information to regulators; and facilitate consistency among sponsors and regulators. This would promote a focus on high value activities, such as data interpretation, and regulatory authorities worldwide would have access to the same data in the same timeframes.
Background to the Proposal
The recent implementation of the EU Clinical Trial Directive has accelerated the need for global harmonization of annual safety reporting for developmental programs. Harmonization is necessary to stem the emergence of technical variations across different regulatory jurisdictions that will have a great impact on resource, but little impact on the public health. An ICH consensus effort would complement that of CIOMS; the concept of a DSUR was introduced by the CIOMS VI Working Group
, and the CIOMS VII Working Group was established to produce additional detail for DSURs
. Timelines for issuance of recommendations from the CIOMS VII Working Group are such that they can be incorporated into the ICH Step 2 document. When more fully developed, the ICH guidance document for DSURs will describe the relationships with stakeholders, including CIOMS and the EU Clinical Trials Facilitation Group, and will provide background on the experience with PSURs.
Concept Papers for all Quality, Safety, Efficacy and Multidisciplinary
topics & The Concept Papers of the topics currently going through the ICH Process for Harmonisation are available below :http://www.ich.org/cache/html/3558-272-1.html#E2F