Regulatory requirements for Dossier submission in African Countries (Kenya, Uganda, and Tanzania) - A Review

  • Juhi Ashwinbhai Randeria Gujarat
  • Ronak Dedania
  • Zarna Dedania
  • Vineet Jain
  • Meghna Danej

Abstract

Africa is world’s second fastest growing pharmaceutical market. The CGAR of African Pharmaceutical market is 10.6%. African people suffer from numerous diseases. The local pharmaceutical market is weak and insufficient to meet the demand of such diseased condition and so Africa relies heavily on externally developed and procured drugs. This combination of economic strength and prevalence of diseases is already driving a demand for medicines across Africa. The objective of this study is to delve in various parameters required for registration for externally developed pharmaceutical product African countries. A dossier containing detailed information about the drug and results of the studies carried out in its development process has to be submitted to the regulating bodies for getting market authorization. CTD is critical for dossier submissions. A comparative study will help the sponsor to file the dossier in many countries simultaneously; which can save time and money. Thus knowledge of guideline specific for individual country becomes important to determine the most stringent member, which shall ease approval process in other target countries in the region.

Keywords: African Countries, Dossier, Registration, CTD, Market Authorization

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References

1. Badjatya J, Bodla R. Drug Product Registration in Semi-Regulated Market. International Journal of Drug Regulatory Affairs [Internet]. 6Feb.2018 [cited 2018 Mar 14];1(2):1-6. Available from: http://ijdra.com/index.php/journal/article/view/3
2. Vidya G, Prabhakaran V, Alagusundaram M and Reddy PJ. Evaluation and comparison of regulatory process and comparison received from various regulatory authorities during pre and post registration of bisoprolol fumarate tablets. IJPDR. 2015; 5(2): 103-12.
3. Suzanne Hill, Kent Johnson. Emerging Challenges and Opportunities in Drug Registration and Regulation in Developing Countries; 2004.
4. Venkatesh MP, Sur S and Kulshreshtha C. Regulatory requirements for Drug Product Registration in West and South African Countries. Int. J. Phar. Res. Schlo. 2016; 5(2):173-88.
5. Health policy division- George institute for international health. Registering new drugs: The African context; 2010. p. 4-8.
6. Sharvya K, Swathi P, Rastrapal D and Suthakaran R. Regulatory Dossiers of Asam Countries. Int. J. Phar. Sci. Res. 2014; 5(8):3144-51.
7. Pharmacy and Poisons Board Guidelines to Submission of Applications [Internet]. PPB; 2010. [Cited on 2017 Dec]. Available from:
http://www.pharmacyboardkenya.org/downloads
8. Guidelines on the Registration of Pharmaceutical for human use in Uganda [Internet]. NDA; 2006 [Cited on 2018 Feb]. Available from:
http://apps.who.int/medicinedocs/documents/s19729en/s19729en.pdf
9. The National drug Policy and Authority (Fees) Regulations [Internet]. NDA; 2014 [Cited on 2018 Feb]. Available from:
http://www.rrfa.co.za/wp-content/uploads/2014/01/Drug-Fees-Regulation-140328.pdf
10. Guidelines on Submission of documentation for Registration of Human Pharmaceutical Products in Tanzania [Internet]. TFDA; 2015 [Cited on 2018 Mar]. Available from:
http://tfda.go.tz/index/sites/default/files/GUIDELINES%20ON%20SUBMISSION%20OF%20DOCUMENTATION%20FOR%20REGISTRATION%20OF%20HUMAN%20PHARMACEUTICAL%20PRODUCTS.pdf
11. Guidelines on Stability Testing Requirements for Active Pharmaceutical Ingredients and Finished Pharmaceutical Products [Internet]. TFDA; 2015 [Cited on 2018 Mar]. Available from:
http://www.rrfa.co.za/wp-content/uploads/2012/11/guidelines-on-stability-testing-requirements-for-apis-and-fpps-150101.pdf
12. The Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations [Internet]. TFDA; 2015 [Cited on 2018 April]. Available from:
https://www.tfda.go.tz/index/sites/default/files/Fees.pdf
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How to Cite
Randeria, J. A., R. Dedania, Z. Dedania, V. Jain, and M. Danej. “Regulatory Requirements for Dossier Submission in African Countries (Kenya, Uganda, and Tanzania) - A Review”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 2, June 2018, pp. 14-21, doi:10.22270/ijdra.v6i2.231.