Journal of Intellectual Property Rights

K. Raja Rajeswari ¹, C. H. Sri Durga ¹, V. Rama Mohan Gupta ¹

Affiliations
1 Pulla Reddy Institute of Pharmacy, Affiliated to Jawaharlal Nehru Technological University, Hyderabad, Telangana-502 313, IN

Abstract

Apart from the regular clinical trials, bioavailability/bioequivalence studies are conducted to assess the safety and efficacy of generic drugs, comparing it with a reference listed drug. Clinical trial data is mandatory for further approval of the drug, for it to enter the market. These investigations are strictly regulated by various global and national regulatory authorities. The global clinical trials market is expected to register a Compound Annual Growth Rate (CAGR) of nearly 4.5% during the forecast period, 2018 to 2023. A major challenge for them to achieve the forecasted growth is meeting the increased level of compliance to the regulations. In recent times the research Organizations have been issued an increased number of warning letters with stringent procedures and even subsequent closure of the organizations. This case study conducted by the review of warning letters and other observations pointed out by two major global regulatory authorities, the FDA and EMA and the critical areas were identified. Recommendations were made for the major areas which were critical and repetitive. It was concluded that consistent methods are required to improve the quality of studies to effectively eliminate the challenges in mere future and contribute for the betterment of the drugs’ market.

Keywords

World Health Organization, Food and Drug Administration, Clinical Research Organizations, Quality Management System, Clinical Trials, Regulatory Authorities, Warning Letters, Medical Devices, Drugs, Biomedical Research.

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