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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

A new template for the Certificate of a Pharmaceutical Product will be put into use in line with China’s pharmaceutical export practices and the latest World Health Organization (WHO) guidelines. The electronic certificate and the paper version are equally authentic. The inspection resulted in a non-compliant rating.

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SQA Regulatory Surveillance Summary for May and June 2024

SQA

The sponsor is also responsible for implementing a Quality Assurance system to ensure that the clinical trial is conducted and data generated, documented, and reported in compliance with the protocol and Good Clinical Practice (GCP) guidelines issued by the CDSCO Directorate General of Health Services Government of India.

FDA 52
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SQA Regulatory Surveillance Summary for May and June 2024

SQA

The sponsor is also responsible for implementing a Quality Assurance system to ensure that the clinical trial is conducted and data generated, documented, and reported in compliance with the protocol and Good Clinical Practice (GCP) guidelines issued by the CDSCO Directorate General of Health Services Government of India.

FDA 40
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SQA Regulatory Surveillance Summary 3 | Monthly Update 2021

SQA

Establishing a Program for the Union’s Action in the Field of Health (EU4Health Programme) for the Period of 2021-2027, Regulation (EU) 2021/522, 24 March 2021. Regulation (EU) 2021/522 establishes a new and reinforced program for the Union’s action in the field of health, called the EU4Health Programme , for the period of 2021-2027.