WHO global benchmarking tool plus rev. VI+ ver. 1 - Registration and Marketing Authorization (MA)

Overview

The issuance of marketing authorizations (also referred as product licensing or registration) is critical to any National Regulatory Authority (NRA). Marketing authorization (MA) refers to a procedure for approval of a medical product for marketing after it has undergone a process of evaluation to determine the safety, efficacy and quality of the product and the appropriateness of the product information. The objective of this regulatory function is to provide a system which ensures that only medical products which have been duly authorized by the NRA are allowed to be manufactured, imported, distributed, sold or supplied to end‐users. The process of assessment for MA includes the review of data on quality, safety and efficacy submitted by the applicant. The same standards should be applied to imported and locally manufactured medical products. Nevertheless, the evaluation of the complex data used to support market authorization of new or novel medical products may require specialized resources and experience not available in the NRA; therefore, countries with limited resources may wish to give priority to well‐established products.