Pharmaceutical Regulatory Affairs: Open Access

Pharmaceutical Good Manufacturing Practice Regulatory Affairs in Sudan: Continuous Debate between Regulatory Authority and Manufacturers

Abstract

Abedellah A, Noordin MI, Zaki and Abdellah Ali

Background: The implementation of GMP requirements in Sudan as developing country imposes pressure on both the manufacturers and regulatory authorities since resources are limited and additional regulatory and manufacturing facilities are required.

Objective: The study aimed to assess the regulatory affairs of pharmaceutical good manufacturing practice in Sudan.

Method: A structured questionnaire was given to the secretary general of the Sudanese National Medicines and Poisons Board (NMPB). Other different questionnaire was conducted to get information from manufacturers. The study questionnaire was validated and analyzed using SPSS software version 20.

Results: The study findings from authority displayed a satisfactory relation between the manufacturers and regulatory authority. In contrast majority of manufacturers (5 out of 7) were not satisfied. Four of manufacturers were strongly agreed and agree with the Sudanese drug registration guidelines. Two of manufacturer’s complaints on delay of medicines release. It was found that there is a lack of local GMP regulatory documents. There is an absence of regulations regarding the reporting of the side effects of medicines by doctors or pharmacists. Capacity shortage is considered as the main problem faced by the Sudanese authority. Controlling the price of medicines is one of the functions of the NMPB.

Conclusion: To strengthen the relation between the manufacturers and regulatory body there is need to enhance the efficiency of meeting. Local GMP guidelines are necessary to improve the application of current regulations. Lack of training personnel and shortage of facilities in pharmaceutical factories exert difficulty in implementation of require GMP. Adoption of a law to report the side effects improve the safety of medicines. NMPB pricing system helps in minimizing escalating GMP implementation costs, but it affected by economic instability. Government support, enhancement of technical cooperation and information exchange with other authorities in different countries will speed up improvement in the GMP regulatory status in Sudan.

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