ABSTRACT
Good Submission Practice (GSubP) refers to the best practices by industries. It is aimed to enhance the quality and efficiency of the medical products registration process by improving the quality of submission as well as its management. Promotion of GSubP by the industries has been recognized as important in facilitating Good Review Practice by the regulatory authorities. The goal of GSubP is to enhance efficiency and quality of medical product registration process which leads to enhance early access to these products by patients. Registration submission of medical products is made in the final stage following time consuming product development process. The objective of GSubP is to help applicants prepare good quality submission leading to successful registration.
