Regulatory advances and prospects of variation filing for the registered parenteral products in USA and Europe

  • Rajdeep G. Makwana
  • Kuldeep V. Desai
  • Vaibhav Kikani
  • Maulikkumar D. Vaja ASSOCIATE PROFESSOR


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).

Keywords: Parenteral products, Variation filing, Regulatory advances, USFDA, EMEA, MAA, CDSCO, PIC/S


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How to Cite
Makwana, R. G., K. V. Desai, V. Kikani, and M. D. Vaja. “Regulatory Advances and Prospects of Variation Filing for the Registered Parenteral Products in USA and Europe”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 2, June 2021, pp. 52-65, doi:10.22270/ijdra.v9i2.470.