Volume : 11, Issue : 10, October – 2024
Title:
CURRENT APPROVAL PROCEDURE FOR NEW REGULATIONS, STANDARDS, POLICIES & GUIDANCE ISSUED BY REGULATORY AUTHORITIES
Authors :
K. Chandra Panda*, V. Lavanya , K. Sundeep
Abstract :
A regulatory process by which a person/organization/sponsor/innovator gets authorization to launch a drug in themarket, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. 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. This article will focus the similarities and differences in drug approval process of various regulatory bodies.
Key Words: Drug approval process, clinicaltrials, marketing.
Cite This Article:
Please cite this article in press K.Chandra Panda et al Current Approval Procedure For New Regulations, Standards, Policies & Guidance Issued By Regulatory Authorities..,Indo Am. J. P. Sci, 2024; 11 (10).
Number of Downloads : 10
References:
1.http://www.who.int/bloodproducts/publications/WHO_TRS_858_A1.pdf
2.https://www.epa.gov/laws-regulations/basics-regulatory-process
3.http://www.nistads.res.in/indiasnt2008/t4industry/t4ind18.htm
4.Dr.HarishDureja.New Drug Approval Process: Regulatory View.http://www.pharmainfo.net/reviews/new-drug-approval-process-regulatory-view
5. Mulaje SS, Birajdar SM, Patil BR, BhusnureOG.Procedure for drug approval in different countries: a review.Journal of Drug Delivery & Therapeutics; 2013, 3(2), 233-238.
6. Shweta Handoo, Vandana Arora, Deepak Khera, Prafulla Kumar Nandi, and Susanta Kumar Sahu.A comprehensive study on regulatory requirements for development and filing of generic drugs globally.International Journal of pharmaceutical Investigation,2012 Jul-Sep; 2(3): 99–105.
7. Sarda Rohit R., Ladkat Nilesh B., Khodade Ravikiran B., Chaudhari Pallavi M.and Kasture Pramod V.The Indian pharmaceutical industry; Evolution of regulatory system and present scenario.International Research Journal of pharmacy,2012, 3 (6).
8.http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm
9.http://files.acecqa.gov.au/files/Assessment%20and%20Rating/Guide%20to%20Assessment%20and%20Rating%20for%20Regulatory%20Authorities_130109.pdf
10.www.oecd.org/…/regulatory-policy/Governance%20of%20Regulators%2
11.Planning Commission of India. 2006. Report of the Working Group for Drugs and Pharmaceuticals for Eleventh Five-Year Plan (Website: www.planningcommission.nic.in)
12.Schuchman, Miriam. 2007. ‘Commercializing Clinical Trials: Risks and Benefits of the CRO boom’. New England Journal of Medicine. October 4.
13.Pacific Bridge. 2007. ‘Medical Device Marketing situation in India
14.Gehl Sampath, Padmashree. 2008. ‘India’s Pharmaceutical Sector in 2008. Emerging Strategies and Global and Local Implications for Access to Medicines
15.OPPI. 2008. Indian Pharmaceutical Industry: Vision 2015.