DRAP Draft Guidance on Clinical Research: Review
The new article describes in detail the regulatory approach to be followed when reviewing the applications related to clinical investigations to be conducted in Pakistan.
The new article describes in detail the regulatory approach to be followed when reviewing the applications related to clinical investigations to be conducted in Pakistan.
The new article highlights the critical points related to the application process, outlining the key steps to be taken when applying for approval in a clinical investigation.
The new article describes in detail the key responsibilities of the parties involved in clinical research.
The article provides a general overview of Pakistan’s regulatory requirements for clinical research.
The new article covers the aspects related to the application of the reliance approach to specific categories of healthcare products and also provides an overview of the reliance procedures. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a...