Dec 7, 2022
Canada
The new article describes in detail the aspects related to the submission of clinical evidence in the context of applications for marketing approval. Table of Contents Health Canada, a country’s regulatory agency in the sphere of healthcare products, has published a...
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Dec 6, 2022
Canada
The article provides an overview of the regulatory requirement related to clinical evidence for medical devices. Table of Contents Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to...
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Jul 14, 2022
Asia
The new article describes in detail the aspects related to the documents the authority expects the applicant to submit concerning the clinical trials. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a...
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Jul 8, 2022
Asia
The new article describes specific aspects related to the registries containing information about clinical trials, and also to the Investigator’s Brochure – a particular document that outlines the key points regarding the clinical study. ...
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Jul 1, 2022
Asia
The new article describes in detail the regulatory matters related to audits or inspections for GCP compliance, as well as the reports and final application review. Table of Contents The Drug Regulatory Authority of Pakistan...
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