Regulatory Compliances in Health Care

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Badagala Saranya

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

The regulation of new drugs in United States is based on NDA (New Drug Application).Its mission is to ensure that patients get access to good medicines without unnecessary delay,help pharmaceutical companies to get their medicines to the market at the right time, help regulatory agencies to approve the right medicines much faster. .NDA provides information to FDA (Food and Drug Adminstration) reviewers if the drug is safe and effective,the benefits of the drug outweighs the risks,drugs proposed labelling is appropriate,the methods and controls used in manufacturing drug to maintain drugs quality are adequate to preserve its identity,strength,quality and purity.Documentation also demands drugs whole story,what happened during clinical trials,how drug behaves in the body,how it is manufactured,processed and packaged.ANDA (Abbreviated New Drug Application) do not require preclinical (animal) and clinical (human) studies to establish safety and effectiveness.It should scientifically demonstrate that their product is pharmaceutically equivalent bio-equivalent with the innovator drug and thus fully interchangeable with the innovator drug.Once approved the applicant can manufacture and market the generic product as safe,effective and low cost alternative.The generic version must deliver the same amount of active ingredients into a patients blood stream in the same time as the innovator drug.

Biography :

I am presently doing my post graduation(M.Pharm) in the branch of Pharmaceuical Analysis and Quality Assurance at Andhra University College of Pharmaceutical Sciences.Did my graduation(B.Pharm) at Shri Venkateswara College of Pharmacy, Etcherla.