Assessment of Regulatory requirements and filing procedure of Drug Master File for Brazil, Europe and South Africa

  • Riya Patel Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology (CHARUSAT), CHARUSAT Campus, Changa- 388 421, Anand, Gujarat, India.
  • Kunal R. Girase Zydus API Park, Zydus Lifesciences Ltd. Vadodara. Vadodara, Gujarat.
  • Venkateshwara T. Rao Zydus API Park, Zydus Lifesciences Ltd. Vadodara. Vadodara, Gujarat.
  • Amit A. Patel Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology (CHARUSAT), CHARUSAT Campus, Changa- 388 421, Anand, Gujarat, India.
  • Ravish J. Patel Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology (CHARUSAT), CHARUSAT Campus, Changa- 388 421, Anand, Gujarat, India.

Abstract

A Drug Master File is a record that consists of detailed, correct data approximately an Active Pharmaceutical Ingredient (API) or Dosage Form of a Finished Product (FP). It is a classified document containing thorough, accurate, and up-to-date information regarding the active medicinal ingredient and medicament. A DMF is divided into two sections: (a) Open part (the Applicant's Part), which includes all of the details needed to determine the quality of a product. And (b) the Closed Part (Restricted Part). The Restricted Part (Closed Part) comprises openly undisclosed manufacturing method knowledge only given to authorized individuals. This compilation aims to offer a comparison of DMF regulatory necessities in addition to the exact data for the registration of lively pharmaceutical ingredients (API) for common drugs in various regulatory governments, including EUROPE (EDQM, EMA), BRAZIL (ANVISA), and SOUTH AFRICA (SAHPRA). This review will provide information on the differences and similarities in the DMF filing requirements in EUROPE, BRAZIL, and SOUTH AFRICA. The regulatory criteria for API registration vary by jurisdiction. Despite the existence and widespread adoption of an ICH-CTD standard format, there are also some limitations. There are a few particular requirements set provided to drug authorities along with the submission. The registration procedure is a regulatory undertaking that permits a person/organization/sponsor/innovator to get permission to participate in the regulation process for fetching marketing authorization/approval.

Keywords: Drug Master File (DMF), Regulatory Requirement, Brazil (ANVISA), Europe (EMA, EDQM), South Africa (SAHPRA)

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References

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How to Cite
Patel, R., K. R. Girase, V. T. Rao, A. A. Patel, and R. J. Patel. “Assessment of Regulatory Requirements and Filing Procedure of Drug Master File for Brazil, Europe and South Africa”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 2, June 2022, pp. 14-27, doi:10.22270/ijdra.v10i2.517.