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Year : 2021, Volume : 14, Issue : 2
First page : ( 1177) Last page : ( 1182)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2021.00210.9

Role of real world data and real world evidence in regulatory decision making

Bharath B. C.1, Balamuralidhara V.2*, Gowrav M. P.3

1Regulatory Affairs Group, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysore-570015, Karnataka, India.

2Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysore-570015, Karnataka, India.

3Lecturer and NSS Programme Officer, Department of Pharmaceutics, JSS College of Pharmacy, S. S. Nagara, Mysuru-570015.

*Corresponding Author E-mail: baligowda@jssuni.edu.in



Online published on 30 April, 2021.


Real-world data contains the information regarding patient health condition and the delivery of health care routinely gathered from the various sources. Usually the information gathered based on the Electronic medical records (EMRs), Product and disease registries, Patient-generated data including in home-use settings etc… Real-world evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. The RWD and RWE is having wide range of applications such as, it helps to reduce the cost of the product approvals, identifying the new uses of the existing product and improving the clinical practices for using drugs and medical products. These types of data are useful for the regulatory decision making. The use of real World Evidence is also having some potential challenges in regulatory decision making for the medical product communications. The RWD and RWE can be utilized by FDA to screen post market wellbeing and adverse events, and it is also used by medical product developers to support clinical trial designs and observational studies to enhance advanced, new treatment approaches. These RWD & RWE are very useful and time saving, the data generated from the RWD is accurate, and by this we could come up with new uses of the drug products, which are already exists in the current market.



Real-world data, Real-world evidence, Electronic health records, Regulatory decision making.


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