The Ghana Food and Drugs Authority is very close to attaining Maturity Level 4 for its medicines regulatory system that ensures the safety, quality and efficacy of all medical products imported, manufactured or distributed in the country. This was disclosed in an address by Dr. Baffour Awuah, the acting Director of Technical Coordination at the Ministry of Health at the just ended India-Ghana Pharma Business Meet, and reiterated by Mr. Samuel Asante Boateng, the Director for drugs and herbal medicines regulation at the FDA.
Maturity level 4 means that the country’s regulatory system is operating at an advanced level of performance and continuous improvement. It is the highest attainable level of maturity.
WHO’s assessment of regulatory authorities is based on the ‘Global Benchmarking Tool’ – an evaluation tool that checks regulatory functions against a set of more than 260 indicators – covering core regulatory functions such as product authorization, testing of products, market surveillance and the ability to detect adverse events – to establish their level of maturity and functionality. Regulatory authorities that reach maturity levels 3 and 4 are eligible for inclusion among WHO-listed authorities, after additional evaluation of their performance.
The WHO supports countries in strengthening their regulatory systems as a means of promoting equitable access to quality assured medical products. This involves the benchmarking of regulatory systems which invites the WHO to apply evaluation tools to generate and analyze regulatory system performance; facilitate the formulation and implementation of institutional development plans; and provide technical support to national regulatory authorities and governments.
There is no doubt that the high-level medicine regulation system will translate into better healthcare delivery in the country.