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Medical R&D Information

Reprinted: NMPA, FDA, EMA news

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Analysis of ICH Regulations

ICH International Technical Requirements of Drug Registration

GxP

The term GxP encapsulates a variety of compliance-related activities, such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Agriculture Practice (GAP), Good Supply Practice (GSP) and Good Review Practice (GRP)

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MedDRA:Medical Dictionary for Regulatory Activities

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Medical translation

Imported drug/device registration