Perspectives in Clinical Research

REVIEW ARTICLE
Year
: 2017  |  Volume : 8  |  Issue : 1  |  Page : 11--16

Regulatory environment for clinical research: Recent past and expected future


Amita Bhave1, Suresh Menon2 
1 Department of Regulatory Affairs, Global Drug Development , Mumbai, India
2 Department of Medical, Novartis Limited, Mumbai, Maharashtra, India

Correspondence Address:
Amita Bhave
Novartis India Limited, Sandoz House, 5th Floor, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai - 400 018, Maharashtra
India

In the past few years, there have been numerous updates to policy and guidelines governing the conduct of clinical research in India. These measures were taken by regulators considering safety of Indian patients as the topmost priority although the overall regulatory environment became challenging. However, in the recent past, Indian regulations have evolved positively to favorably support clinical research in India while appropriately balancing patient safety as well. These regulatory changes are expected to bring newer innovative medicines to Indian patients at an earliest.


How to cite this article:
Bhave A, Menon S. Regulatory environment for clinical research: Recent past and expected future.Perspect Clin Res 2017;8:11-16


How to cite this URL:
Bhave A, Menon S. Regulatory environment for clinical research: Recent past and expected future. Perspect Clin Res [serial online] 2017 [cited 2017 Mar 23 ];8:11-16
Available from: http://www.picronline.org/article.asp?issn=2229-3485;year=2017;volume=8;issue=1;spage=11;epage=16;aulast=Bhave;type=0