Quality regulating drug

Governments are also key players in the development of new drugs. They regulate and provide guidance for the development and approval of new drugs for marketing. In some countries they also play a role in pricing and reimbursement. After the launch of a new product they closely follow its safety, quality and various other aspects such as inappropriate use, promotion, etc. 

Wiggins, S. N., Product Quality Regulation and New Drug Introductions Some New Evidence From the 1970s, The Review of Economics and Statistics 63(4) 615-619,1981. 

In addition to the regulation of clause 2, if it is judged that there is a change in facilities or a problem in drug quality, the KGMP approved firm shall be inspected at anytime. 

Regulating drug quality is a federal concern that is reflected beyond the approval process. FDA has implemented extensive regulations to ensure that drug products, which are produced and marketed, as well as their chemical constituents, continue to meet high standards of quality, purity, and safety, and have the identity and strength accurately represented. 

With a prescriptive approach to quality assessment, duplicate samples, blanks, standards, and spike recoveries are measured following a specific protocol. The result for each analysis is then compared with a single predetermined limit. If this limit is exceeded, an appropriate corrective action is taken. Prescriptive approaches to quality assurance are common for programs and laboratories subject to federal regulation. For example, the Food and Drug Administration (FDA) specifies quality assurance practices that must be followed by laboratories analyzing products regulated by the FDA. 

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