Product assessment and registration (also known as marketing authorization and product licensing) are carried out by drug regulatory authorities to ensure that a pharmaceutical product has been adequately tested and evaluated for safety, efficacy and quality and that the product information provided by the manufacturer is accurate. They involve evaluating technical and administrative data submitted about a drug product, deciding whether to approve or reject the product, issuing a marketing authorization (certificate) and conducting ADR monitoring. The overall process requires a legal foundation, an adequate number of qualified staff, sustainable resources, a data retrieval system and a system to ensure freedom from conflicts of interest, accountability and transparency. GMP inspection and QC services are also necessary to ensure that GMP requirements are adhered to and to carry out quality testing. This chapter describes the drug assessment and registration situation in the 10 countries.