A comprehensive review on Drug Product registration and approval process in Brunei Darussalam and Ukraine

  • Veer Patel Mr.

Abstract

The drug and drug product registration and approval processes vary in each country which is regularized by the statutory drug regulatory agencies. This review gives detailed information on the regulatory requirements for drug product registration in Brunei Darussalam and Ukraine. Departments working under the administration of Ministry of Health are working for the drug product registration and approval in both the countries, respectively. Dossier submission is a preliminary requirement for any pharmaceutical product to be marketed. The specifications for Dossier in both the countries are likely to be similar but they adhere to different guidelines for Dossier requirements. The timelines for drug product registration depends upon the type of product and the adequacy of the data submitted to the authority. A comprehensive study of submission requirements, registration process and role of drug regulating departments of Brunei Darussalam and Ukraine will help to understand the regulatory procedures of both the countries in a precise manner.

Keywords: Brunei Darussalam Medical Control Authority (BDMCA), ASEAN Common Technical Dossier (ACTD), Dossier, drug registration Unit (DRU), State Expert Center (SEC)

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How to Cite
Veer Patel. “A Comprehensive Review on Drug Product Registration and Approval Process in Brunei Darussalam and Ukraine”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 3, Sept. 2020, pp. 62-69, doi:10.22270/ijdra.v8i3.410.