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Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19

Due to the ongoing, international impact of COVID-19, FDA is issuing this guidance to temporarily provide the Accredited Third-Party Certification Program’s currently-recognized ABs and accredited CBs flexibility, in certain circumstances.
United States Drug Administration Party Certification Program Public Health Emergency Party Certification Party Certification Program Onsite Observation
Source: fda.gov

China's Personal Information Protection Law Data Transfers

China Personal Information Protection Law PIPL more info from Cyberspace Administration of China incl China standard Contractual Clauses transfer personal info, China foreign processing of personal information, China Cyberspace Administration security assessment
China Cybersecurity Review Technology Party Certification Certification Center Cyberspace Administration Of China The Cyberspace Administration Cyberspace Administration Mandatory Security Assessment

Cross-Border Data Transfers Under China's Personal Information Protection Law | Womble Bond Dickinson

In February 2023 Cyberspace Administration of China (the “Cyberspace Administration”) published rules on Standard Contractual Clauses for transfer of personal information to third...
Party Certification China Cybersecurity Review Technology Cyberspace Administration Cyberspace Administration Mandatory Security Assessment Certification Center Cyberspace Administration Of China The

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FDA Announces The Discontinuation Of Certain COVID-19-Related Guidance Documents - Operational Impacts and Strategy

In the wake of the Department of Health and Human Services' (HHS) February announcement that they will be discontinuing the COVID-19 public health emergency (PHE) declaration on May 11, 2023...
United States Coagulation Systems For Measurement Of Viscoelastic Properties Health Care Guidance Documents Expiring With The Public Health Expiration Of The Public Health Emergency Development Of Monoclonal Antibody Products
Source: mondaq.com

The Long (Un)Winding Road: FDA Maps Out How The End Of The Public Health Emergency Will Impact Its COVID-19 Policies - Operational Impacts and Strategy

Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be available...
Party Certification Public Health Emergency Guidance Human Services Regulatory Affairs Development Of Monoclonal Antibody Products Targeting Animal Drug Development
Source: mondaq.com

China: updates on international data transfers - security assessment requirements taking effect on 1 September | Hogan Lovells

Recent weeks have seen a flurry of activity in China’s regulation of international data transfers. Three principal data laws, the Cyber Security Law (“CSL”), the Data Security Law...
China National Information Security Standardization Technical Committee Chinese People Court Guidance On Network Security Standardized Practice Third Party Certification China International Economic Cyberspace Administration Of China

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