FACTS ON DRUG REGULATIONS

  • Rajkumar Gupta

Abstract

The pharmaceutical products are very much driven by the drug regulation imposed by ministry of health in individual countries. The basic facts on regulations is that they are mandatory and noncompliant are punishable under the law. Further, compliance is not a one time job but it is an exercise to be performed over the life cycle of the drug products. It starts from development of the products and continues till the product is in market. The information, registration, permission and extensions/withdrawals are the primary regulatory requirements for the drug products.


The main focus of drug regulations is to check that safety, quality and efficacy of the drug products over its lifecycle.

Keywords: GLP, GCP, GMP, FDA, regulation, Marketing Authorization.

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References

1. FDA Guidance Documents. Regulatory Information [Internet]. 2012 March 12 [cited, 2014 March 2]; Available from:
http://www.fda.gov/regulatoryinformation/guidances/
2. FDA Warning letter. Inspections, Compliance, Enforcement, and Criminal Investigations [Internet]. 2014 [cited, 2014 March 12]; Available from:
http://www.fda.gov/iceci/enforcementactions/WarningLetters/default.htm
3. FDA. Guidance, Compliance, & Regulatory Information. [Internet]. 2014 [cited, 2014 March 18]; Available from:
http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/default.htm
4. European Medicines agency. Human Regulatory. [Internet]. 2013 [cited, 2014 March 23]; Available from:
http://www.ema.europa.eu/ema/
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How to Cite
Gupta, R. “FACTS ON DRUG REGULATIONS”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 3, Feb. 2018, pp. 43-47, doi:10.22270/ijdra.v2i3.140.