ZAZIBONA recommends 4 new products for registration

Submitted by hlazom on Fri, 08/03/2018 - 13:41
Promote To Nepad SIte
Off

A total of four (4) new products have been recommended for registration through the ZAZIBONA Initiative in four therapeutic classes namely; analgesic, antibiotics, antineoplastic and blood thinning agent. This took place at the 18th ZAZIBONA Assessment Session in Gaborone, Botswana from 26th February to 03rd March 2018.

During the session a total of 9 new products were discussed, 4 recommended for registration and 0 were recommended for rejection. A total of 21 additional data was also considered during this meeting. This positive outcome of the 18th joint assessment session builds upon the work of the ZAZIBONA collaborative procedures from 2017.

ZAZIBONA helps to improve access to medicines for SADC Member States by reducing the timelines for registration through joint collaborative processes. One of the biggest challenges to public health in the SADC region is access to medicines with the medicines registration processes taking up to three years in some countries. ZAZIBONA was established to address this challenge and also conduct joint Good Manufacturing Practise (GMP) inspections to reduce the workload and improve technical improved capacity to conduct inspections.

Since its establishment, the ZAZIBONA Initiative has grown with more countries from the Southern Africa Development Community (SADC) joining and expressing interest to participate in the process. South Africa, Angola, Democratic Republic of Congo (DRC) and Seychelles have now joined. 

Two manufacturing sites successfully inspected

A total of 3 manufacturing sites located in India have been inspected between 06 – 18 March 2018 by inspectors from Namibia, South Africa and Zimbabwe. The scope for two of the sites was sterile product manufacturing while the third site was oral solid dosage forms. Interim Inspection Reports have been availed to the manufacturing sites and upon receipt of the Final Inspection Reports, the manufacturers will be given 60 days to respond to the observations made through presentation of Corrective Actions and Preventive Actions (CAPA).

In addition, desk reviews to consider the approval of two sites, one in India and another in Cyprus are also nearing conclusion. The inspections and desk reviews will be concluded in a virtual meeting of inspectors from all active countries. The meeting will discuss the findings and the CAPAs, and finalise recommendations for approval or rejection of the manufacturing sites.