• The SFDA is not obligated to approve the application even if it receives approval by reference from a drug regulatory agency.
• During evaluation and for safety, efficacy or quality concerns, the related departments might request to transfer the application to the regular pathway. However, SFDA commits to clarify the decisions for any case.
• Applicants are required to adhere to the chosen reference agency throughout the product's lifecycle. For all variation requests, applicants must submit supporting documentation that conforms to the approvals issued by the chosen reference agency. For example, if an abridged pathway registration is based on an EMA decision, all subsequent variation requests must also utilize the EMA as the reference agency. Supporting documentation from the FDA will not be accepted.
• SFDA reserves the right to reject the application if the applicant submits false or misleading information.
• Confidential information which submitted by the companies to support their registration application is protected and will not be shared by any means with other parties.