CURRENT APPROVAL PROCEDURE FOR NEW REGULATIONS, STANDARDS, POLICIES & GUIDENCE ISSUED BY REGULATORY AUTHORITES

Main Article Content

Alli Bhagya Raj
K. Nagasree
Y. Sirisha

Keywords

.

Abstract

A regulatory cycle, by which an individual/association/support/pioneer gets approval to send off a medication in the market, is known as drug approval process. As a general rule, a drug approval process contains different stages: application to conduct clinical preliminaries, directing clinical preliminaries, application to promoting approval of drug and post-showcasing studies. Each nation has its own regulatory power, which is dependable to authorize the standards and guidelines and issue the rules to manage the marketing of the drugs. This article will concentrate the similarities and contrasts in drug approval process of different regulatory bodies.

Abstract 35 | pdf Downloads 41

References

1. https://www.sciencedirect.com/topics/medicine-and-dentistry/regulatory-affairs
2. http://www.who.int/bloodproducts/publications/WHO_TRS_858_A1.pdf
3. https://www.epa.gov/laws-regulations/basics-regulatory-process
4. http://www.nistads.res.in/indiasnt2008/t4industry/t4ind18.htm
5. Dr.Harish Dureja.New Drug Approval Process: Regulatory View.http://www.pharmainfo.net/reviews/new-drug-approval-process-regulatory-view
6. http://pharmaceuticals.gov.in/pharma-industry-promotion.
7. http://apps.who.int/medicinedocs/en/d/Js23088en/.
8. Notification dated February 14, 2017 issued by Ministry of Chemicals & Fertilizers http://pharmaceuticals.gov.in/sites/default/files/CommitteePatentedDrugs_0.pdf.
9. PM’s Speech in Surat while inaugurating the multi-specialty hospital and research center of Samast Patidar Arogya Trust, April 17, 2017.
10. Amendment in Clause 1.5 Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 vide notification dated September 21, 2016.
11. GSR 327(E) dated April 3, 2017.
12. G.S.R.302(E)datedMarch30,2017: http://www.cdsco.nic.in/writereaddata/GSR%20302(E)%20dated%2030_03_2017.pdf
13. http://www.cdsco.nic.in/writereaddata/public%20notice16march.pdf.
14. http://www.cdsco.nic.in/writereaddata/Circular-notice-order%2018_11_2015.pdf.
15. http://www.cdsco.nic.in/writereaddata/public%20notice16march.pdf.
16. MedicalDevicesRules2017: http://www.cdsco.nic.in/writereaddata/Medical%20Device%20Rule%20gsr78E.pdf.
17. http://www.cdsco.nic.in/writereaddata/notice%2029_6_2017.pdf.
18. http://www.cdsco.nic.in/writereaddata/Essential%20Principles%20for%20safety.pdf.
19. CS(OS) No.355/2014, Delhi High Court.
20. Interim Order dated April 25, 2016 in CS(OS) No.355/2014, Delhi High Court.
21. Carlos E. Durán, Martín Cañás, Martín A. Urtasun, Monique Elseviers, Tatiana Andia, Robert Vander Stichele, and Thierry Christiaens, Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries, Pan American Journal of Public Health, Rev Panam Salud Publica 45, 2021.
22. V. Vennu and P. P. Saini, India's Clinical Trial Regulatory Changes, Indian Researcher?s Awareness of Recently Changed Regulations, and the Impact of the New Drugs and Clinical Trial Rules: A Review, Indian J Pharm Sci 2020;82(5):726-740.
23. Marina A. Malikova, Practical applications of regulatory requirements for signal detection and communications in pharmacovigilance, Therapeutic Advances in Drug Therapy, 2020.
24. Sawant AM, Mali DP and Bhagwat DA, Regulatory Requirements and Drug Approval Process in India, Europe and US, Pharmaceut Reg Affairs 2018, 7:2.
25. Nithya J Gogtay, Renju Ravi, and Urmila M Thatte, Regulatory requirements for clinical trials in India: What academicians need to know, National Library of Medicine, 2017, 61(3): 192–199.
26. Sonal Jain, Regulatory Requirements For New Drug Approval In Different Countries: An Overview, World Journal of Pharmaceutical Research, 20166-6407.
27. Prajapati Visha, Goswami Rahulgiri, Makvana Pratik, Badjatya Jitendra Kumar, A Review On Drug Approval Process For Us, Europe And India, International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11.