Call for laws to allow cross border control of medicine in EAC
Permanent Secretary in the Ministry of Health, Community Development, Gender, Elderly and Children, Dr Mpoki Ulisubisya
What you need to know:
- Substandard and fake drugs were serious health scare
- TFDA reiterate its support of integration agenda
Dar es Salaam. East African Community (EAC) member states have been urged to adopt laws that would be harmonised to allow cross border control of medical products.
The challenge was raised by Permanent Secretary in the Ministry of Health, Community Development, Gender, Elderly and Children, Dr Mpoki Ulisubisya, when officiating the 10th steering committee meeting of the EAC Medical Regulatory Harmonisation Program held recently.
He said collective efforts were needed to ensure the region was free from sub-standard and counterfeit medical products.
According to him, there is also a need for concerted efforts to curb clandestine manufacturing and illegal smuggling of falsified products that end-up to users.
The PS cautioned that if such products find their way into the regional market, they might end up in hospitals with devastating health consequences.
Dr Mpoki told committee members which comprised of Chief Pharmacists from EAC partner states and Heads of National Medicines Regulatory Authorities in the region that the institutions they were leading were very crucial in protecting and promoting public health in the region.
“These institutions provide a rate-limiting step in any healthcare system to halt poor quality, unsafe and ineffective medical products from reaching our markets,” he said.
He also revealed that EAC member states have set a target that by the end of this year, all medicines and medical equipment entering into any member state must be of the same quality as per agreed regulations by the region.
Dr Mpoki said that the Medicine Harmonization Program under review which began in 2012 has recorded good results as it has managed to put in place harmonized systems, setting up guidelines and procedures.
He appreciated the technical and financial support rendered to the program by various partners including World Health Organisation (WHO), the Bill Gates Foundation, the Swiss Development Cooperation, and United Kingdom’s Department for International Development, the World Bank and NEPAD Agency.
Apart from thanking them, Dr Mpoki expressed his optimism that those partners would continue supporting the program as it entered its third phase which would embrace other regulatory functions namely pharmacovigilance, post marketing surveillance, medical devices regulations as well as vaccines and other biological products control.
Meanwhile, Tanzania Food and Drug Authority (TFDA) has reiterated its commitment in the integration agenda as agreed by EAC council of ministers of health to ensure a harmonized and functioning medicines regulation system within the bloc.
The move is in accordance with national and internationally recognised standards best practices.
TFDA’s Director General Mr Hiiti Sello told members of the committee and partners attending the meeting that since official inauguration of the Regulatory Harmonization Program in March 2012.
He said TFDA receives applications on behalf of national medicines regulatory authorities of member states and coordinates joint assessment sessions.
According to him, since October 2015, six joint assessments sessions have been conducted where 38 medicinal products applications were discussed and eight products were registered.
Mr Sello explained that in January, 2015, the authority adopted CTD guidelines on submission of documentation for registration of human pharmaceutical products which were made operational in July, 2015.
The TFDA boss further added that his institution was implementing the compendia guidelines on good manufacturing practices.
“These guidelines were harmonized jointly by EAC Partners States national medicines regulatory authorities and were approved for use by council of ministers on 20th September, 2014.” He elaborated.
He went on to explain that, his authority has also managed to develop and implement quality management system which was also another milestone of the program in order to deliver quality and consistent services to its customers.
“TFDA became ISO 9001: 2008 Certified in 2009 and in 2017 TFDA has been awarded ISO 9001:2015 certificates following successful audit conducted in July, 2017,” Mr Sillo explained.
The two-day steering committee meeting was preceded by a two-week training on assessment of bioequivalence data conducted at designated Regional Centre of Regulatory Excellence in Medicines Evaluation and Registration which is the consortium of TFDA and School of Pharmacy of Muhimbili University of Health and Allied Sciences.
