Regulatory advances and prospects of variation filing for the registered parenteral products in USA and Europe
Abstract
Drug Regulatory Affairs (DRA) is a vital unit in a pharmaceutical company. It is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safety and efficacy in pharmaceuticals, veterinary medicines, medical devices, cosmetics and complementary medicines, healthcare products to individuals around the world. Regulatory affairs (RA) professionals are employed in pharmaceutical industry, government, academic research and clinical institutions. As India is growing very rapidly in pharmaceutical sector, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Today 35 member countries along with 11 candidate countries and 4 international agencies have joined together to create the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to promote a globally accepted GMP. Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for marketing authorization Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and regulatory requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO).
Downloads
References
2. Joseph L,George M, Kalpesh M, Bincy C and Jitendra B. “Comparative Study for Generic Drug Approval Process and their Registration as per CTD in Europe, USA and Brazil”, Int. J. Drug Regulatory Affairs. 2016;4(2):1-9.
3. Lakshmi M, “Advances in the Review of Generic Drug Applications by United States Food And Drug Administration, A Regulatory Perspective in The Era Of GDUFA (Generic Drug User Fee Amendment 2012)”, Int. J. Drug Regulatory Affairs. 2015;3(1): 41-61.
4. Philip S, “The Scope of Regulatory Affairs in the Pharmaceutical Industry” Hygeia. J.D.Med. 2010;1-6.
5. “ICH Official web site : ICH [Internet]. ICH; 2021 [cited 2021 May 15]. Available from: http://www.ich.org/home.html
6. Fda.gov. What does FDA regulate? [Internet]. FDA; 2020 Mar 08 [cited 2021 May 15]. Available from: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm
7. Uky.edu. [Internet]. research.uky [cited 2021 May 15]. Available from: http://www.research.uky.edu/ori/ORIForms/D116-FDA-Resources.pdf
8. Office of the Commissioner. U.S. Food and Drug Administration [Internet]. FDA; 2021 [cited 2021 May 15]. Available from: https://www.fda.gov/default.htm
9. Europa.eu. [Internet]. EMEA; 2021 [cited 2021 May 12]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/home/Home_Page.jsp&mid
10. Europa.eu. [Internet]. EMEA; 2021 [cited 2021 May 15]. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol.
11. Fda.gov. Changes to an Approved NDA or ANDA. Guidance for Industry [Internet]. FDA; 2004 Apr [cited 2021 May 12]. Available from: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm077097.pdf
12. Health USD, Services H. Guideline for Submitting Documentation for the Manufacture of and Controls for Drug Products. Food and Drug Administration. 1987;1–6.
13. Krishna G, “Post Approval Regulatory Requirements for A New Drug Application (NDA)”, Am. J. PharmTech Res. 2013;3(1).
14. Anu K and Vivek C, “Recent Review on Parenteral Products – Sterile Dosage Form”, IJARIIE. 2017; 3(1).
15. Vishal P, Rahulgiri G, Pratik M, and Jitendra B. A Review On Drug Approval Process For US, Europe and India. Int. J. Drug Regulatory Affairs. 2014; 2(1):1-11.
16. FDA.gov. M4: The CTD -- General Questions and Answers [Internet]. FDA; 2004 Dec [cited 2021 May 10]. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073276.pdf
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM
