The United States Food and Drug Administration (USFDA) is authorized under 21 C.F.R. § 20.89 to disclose non-public information to the Saudi Food and Drug Authority, Kingdom of Saudi Arabia (SFDA) regarding medical products used, or proposed to be used, for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) purposes as part of cooperative law enforcement or cooperative regulatory activities.
The Saud i Food and Drug Authority (SFDA) understands that some of the information it receives from USFDA on MERS-CoV medical products may include non-public information exempt from public disclosure under the laws and regulations of the United States of America, which is confidential commercial information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. The SFDA understands that this non-public information on MERS-CoV medical products is shared in confidence and that USFDA considers it critical that the SFDA maintain the confidentiality of the information. Public disclosure of this information by the SFDA could seriously jeopardize any further scientific and regulatory interactions between USFDA and the SFDA. USFDA will advise the SFDA of the non-public status of the information at the time that the information is shared-
Therefore, the SFDA certifies that it:
- has the authority to protect from public disclosure such non-public information provided to the SFDA in confidence by USFDA;
- will not publicly disclose such USFDA-provided non-public information without the written authorization of the owner of the information, the written authorization from the individual who is the subject of the personal privacy information, or a written statement from USFDA that the information no longer has non-public status;
- will inform USFDA promptly of any effort made by judicial or legislative mandate to obtain USFDA -provided non-public information from the SFDA. If such judicial or legislative mandate orders disclosure of USFDA-provided non-public information, the SFDA will take all appropriate legal measures in an effort to ensure that the information will be disclosed in a manner that protects the information from public disclosure; and
- will promptly inform USFDA of any changes to the Kingdom or Saudi Arabia's laws, or to any relevant policies or procedures that would affect the SFDA's ability to honor the commitments in this document.
Dr. Ibrahim A. Aljuffali, M.Sc., Ph.D. Date 10/11/2015
Executive Vice President for Drug Affairs
Saudi Food and Drug Authority
Riyadh, Saudi Arabia