The International Council on Harmonisation (ICH) has outlined a proposal to extend the remit of the Points to Consider (PtC) Working Group to provide more detailed guidance, examples and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors and product quality issues.
According to a new concept paper endorsed by the ICH MedDRA (Medical Dictionary for Regulatory Activities) Management Board in November 2016, topics that could be of use for more expanded guidance include “data quality in regulatory submissions – both in clinical trials and postmarketing – where it is recognized that poor quality in the initial data collection and subsequent coding and analysis steps can compromise the ability to evaluate safety issues with regulated products.”
In addition, the working group says there is “considerable demand from MedDRA users for detailed examples and ‘Questions and Answers’ (Q&As) on special topics of regulatory importance such as medication errors and product quality issues.”
Guidance and examples will be agreed upon by all ICH parties, rather than regulator-specific examples as provided, for instance, by the EU in its guidelines on medication errors or FDA’s data standards guidance.
“The PtC WG proposes that the companion document would be a dynamic, ‘living’ document that would be updated on a frequent basis, according to users’ needs and thus it would not be tied to the biannual update of the PtC documents that is performed with each MedDRA release,” the concept paper says.
The working group also claims that a section on data quality would obviate the need for a separate Maintenance and Support Services Organization (MSSO) Best Practice document on data quality that was approved as an action by the MedDRA Management Board at its meeting in June 2016.
The PtC WG also notes that there are several sources of material available for consideration for the companion document, including: Q&As developed by the European Industry MedDRA User Group following its 2015 webinar on medication error coding; questions received by the MSSO/JMO Help Desk; and issues identified by FDA in its adverse event reporting system coding QA review.
“This material can serve as a starting point to be reviewed for applicability to the ICH regions, expanded as needed, and subsequently placed in the companion document where it will be easily accessible as a valuable resource for users,” the paper reads.
The M1 PtC Concept Paper available now on the ICH Website