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Posted On: 02/23/2021 11:14:05 AM
Post# of 148908
Thoughts on confidentiality agreements
A poster on YMB noted that the FDA has a confidentiality agreement with the UK's MHRA. The agreement goes back to 2017. It is possible that the FDA is in discussions with MHRA about distribution, timing of approvals, etc. The following paragraphs cover the relevant portion:
The United States Food and Drug Administration (FDA) is authorized under 21 C.F.R. § 20.89 to disclose non-public information to the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) regarding FDA-regulated drugs, including pre- and post-market activities, as appropriate, as part of cooperative law enforcement or cooperative regulatory activities. FDA is further authorized under section 708(c) of the Federal Food, Drug, and Cosmetic Act to share with a foreign government, as it deems appropriate and under limited circumstances, certain types of trade secret information.
The Commissioner of Food and Drugs has certified MHRA as having the authority and demonstrated ability to protect trade secret information from disclosure. FDA therefore may provide MHRA with certain types of trade secret information at FDA’s discretion and upon request by MHRA, based on the following certifications.
MHRA understands that some of the information it receives from FDA may include non-public information exempt from public disclosure, such as commercially confidential information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. MHRA understands that this non-public information is shared in confidence and that it is critical that MHRA maintains the confidentiality of exchanged non-public information. Public disclosure of exchanged non-public information by MHRA could seriously jeopardize any further scientific and regulatory interactions between MHRA and FDA. FDA will advise MHRA of the non-public status of the information at the time that the information is shared.
https://www.fda.gov/international-programs/co...commitment
But NP said they are also in discussions with Canada. I found a similar agreement with Canada.
https://www.fda.gov/international-programs/co...commitment
I wondered why the PR did not also list discussions with the Philippines. My search did not turn up any confidentiality agreements with the Philippines, so perhaps those discussions will not progress until after the FDA discussions are concluded.
While this is obviously speculation, it does align with the PR.
A poster on YMB noted that the FDA has a confidentiality agreement with the UK's MHRA. The agreement goes back to 2017. It is possible that the FDA is in discussions with MHRA about distribution, timing of approvals, etc. The following paragraphs cover the relevant portion:
The United States Food and Drug Administration (FDA) is authorized under 21 C.F.R. § 20.89 to disclose non-public information to the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) regarding FDA-regulated drugs, including pre- and post-market activities, as appropriate, as part of cooperative law enforcement or cooperative regulatory activities. FDA is further authorized under section 708(c) of the Federal Food, Drug, and Cosmetic Act to share with a foreign government, as it deems appropriate and under limited circumstances, certain types of trade secret information.
The Commissioner of Food and Drugs has certified MHRA as having the authority and demonstrated ability to protect trade secret information from disclosure. FDA therefore may provide MHRA with certain types of trade secret information at FDA’s discretion and upon request by MHRA, based on the following certifications.
MHRA understands that some of the information it receives from FDA may include non-public information exempt from public disclosure, such as commercially confidential information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. MHRA understands that this non-public information is shared in confidence and that it is critical that MHRA maintains the confidentiality of exchanged non-public information. Public disclosure of exchanged non-public information by MHRA could seriously jeopardize any further scientific and regulatory interactions between MHRA and FDA. FDA will advise MHRA of the non-public status of the information at the time that the information is shared.
https://www.fda.gov/international-programs/co...commitment
But NP said they are also in discussions with Canada. I found a similar agreement with Canada.
https://www.fda.gov/international-programs/co...commitment
I wondered why the PR did not also list discussions with the Philippines. My search did not turn up any confidentiality agreements with the Philippines, so perhaps those discussions will not progress until after the FDA discussions are concluded.
While this is obviously speculation, it does align with the PR.
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