Is there an international agreement regarding the order in which MedDRA SOCs should appear on Product Labeling?
There is an agreement to the international order of SOCs, which is included with each MedDRA release and can be found in either the Introductory Guide supporting document (Version Documentation) or in the Intl_ord.asc file. On what date does a new MedDRA release need to be implemented? Do FDA and EMEA expect the users to recode all old cases or does implementation mean that the new cases and follow-ups should be coded with the new version? As of right now, there is no required date by which regulators start using the next version of MedDRA. The post-market reporting document authored by the MSSO recommends that organizations update their systems with the latest version of MedDRA by 60 days after the release of MedDRA. This does not mean that all data must be re-coded, just that all organizations would start using the latest version of MedDRA. The EMEA has, in some cases, required users to recode data back to 1995. During the 60 day period, it was envisioned that organizations would rev
