The Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (KKDIK) requires existing and/or potential registrants to make every effort to reach an agreement on data sharing and to ensure that the cost of sharing the information required for registration is determined fairly, transparently, and in a non-discriminatory manner. The rules necessary to ensure the efficient implementation of existing obligations regarding joint submission and data sharing are included in the Data Sharing Guidance. Update Content Summary of Key Aspects Explained in the Data Sharing Guidance The key aspects explained in the Data Sharing Guidance are summarized below: The Data Sharing Guidance ensures that the information required for the registration process is shared fairly, transparently, and in a non-discriminatory manner. This guidance outlines the obligations related to agreements and the management of data and cost-sharing required under KKDIK. Fundamentally, under KKDIK, a registrant or potential registrant must: The rules required to ensure the efficient implementation of existing obligations regarding joint submission and data sharing by registrants or potential registrants are provided in this guidance. The relevant guidance states that both administrative costs and costs related to information requirements must be shared transparently among only the registrants concerned and clarifies the mandatory elements that must be included in each agreement. Data Sharing Agreement According to the Data Sharing Guidance, a data-sharing agreement must be established. The parties are free to agree on the format of the data-sharing agreement within the scope of contractual freedom. However, regardless of the chosen format, the fundamental principles of fairness, transparency, and non-discrimination outlined in the KKDIK Regulation must be upheld.In any case, data sharing is designed not to generate profit for the data owner(s) but to share the actual costs incurred. The following mandatory elements must be included:a) A list of the data to be shared and associated costs,b) A list and justification of administrative costs,c) A cost-sharing model that must include a reimbursement mechanism; the inclusion of potential future data needs in the cost-sharing model should also be considered. Each registrant must be the legal owner of the study report or have permission to refer to the study report for the study summary and/or robust study summary submitted for registration. Joint registrants should have access to all the information submitted on their behalf in the joint registration dossier that they need for registration and have paid for. By paying for access to the joint submission, joint registrants should have access to at least the endpoint conclusions they have paid for, or if available, a copy of the robust study summary and study summary. Regarding the content of the dossier and the type of access obtained through the agreed cost-sharing, the following elements should be clear and understandable for all parties in the data-sharing agreement: In the event of a data-sharing dispute under the KKDIK Regulation, the Ministry will consider whether the parties have acted in accordance with the obligations specified in the guidance. During data-sharing negotiations, the parties are obligated to make every effort to reach an agreement on data sharing in a fair, transparent, and non-discriminatory manner.
