Can I read Schedule Y: Clinical Trial Regulations on EtoBox?

Schedule Y: Clinical Trial Regulations by Akshay Joshi is a document available to read on EtoBox.

What is Schedule Y: Clinical Trial Regulations about?

The document summarizes the key aspects of Schedule Y under the Drugs and Cosmetics Act and Rules. It provides an overview of Schedule Y and the requirements for permission to import, manufacture or conduct clinical trials of new drugs in India. It describes the objectives of the Act, relevant rules regarding clinical trials and new drug definitions. It also lists and briefly describes the 12 appendices that provide detailed guidelines on various aspects of clinical development and regulatory requirements.

Author

Akshay Joshi

Language

EN