Wednesday , 12 May 2021

Evaluation and Comparison of Regulatory Strategy and Communications received from various Regulatory Authorities during Pre & Post Registration of “Piperacillin and Tazobactum for Injection”

Dr. Hareesh Dara*, D Siva Dinesh
St.John College of Pharmcy, Hasanparthy, Hanamkonda, Telangana.

Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, these are realizing that the real battle of survival lies in executing the work by understanding the guidelines related to various activities carried out to give an assurance that the process is under regulation. This article focuses on guidelines and regulatory requirements of different countries of different Regions like ASEAN, CIS, LATAM and African.
Keywords: Piperacillin and Tazobactum, Regulatory Strategy, Regulatory Authorities

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