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...
Asia The new article provides additional clarifications regarding the specific Essential Principles, and also describes the way they should be followed. In particular, the present article describes the principles to be applied concerning device-drug combination products...
Asia The new article highlights specific aspects of the principles related to the medical devices emitting radiation, as well as the ones intended to be used by laypersons or containing materials of biological origin. Table of Contents The...
Asia The new article provides additional details regarding the regulatory requirements for the importation of investigational products, as well as other aspects. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP),...
Asia The new article provides an overview of the Essential Principles for specific types of medical devices, such as active medical devices, the ones with measuring functions, as well as software-based products. Table of Contents The Health...
