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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. China’s drug MAH system has been implemented nationwide since the revised Drug Administration Law came into force in 2019.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA

In addition, it contains essential recommendations to avoid complications and protect public health. Aimed at both consumers and professionals of aesthetic clinics, the alert clarifies the precautionary ban on certain products. Analysts documented original laboratory data on uncontrolled sheets of paper.

FDA 40
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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

This guidance does not intend to elaborate on aspects related to the clinical evaluation or cybersecurity for these products, as those are described in other guidelines ( MDCG 2020-1 on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software; MDCG 2019-16 on Cybersecurity for medical devices).

FDA 52