Once implemented, the MENA Regional Laboratory Network will encourage communication among participating countries; review guidelines for drugs approval across the region; and take steps towards eliminating substandard and counterfeit drugs, anticipates USP.
Mat Heyman, USP vice president for external affairs and strategic integration, said that by regimenting manufacturing procedures across MENA drug control laboratories, the Network can help harmonise global pharmaceutical quality systems, bringing more medicines that meet global regulatory requirements.
The Network was created by senior officials of government laboratories from Abu Dhabi, Egypt, Jordan, Morocco, Saudi Arabia, and Tunisia, following a meeting with USP officials earlier this month.
Heyman told in-PharmaTechnologist, “The participating MENA governments recognise that the pharmaceutical sector is growing in the MENA region in response to a demand for more access to medicines for a fast growing population.”
He went on to say, “Like any other region of the world, the increase in volume of pharmaceutical goods is paralleled by an increased risk of introduction of counterfeit or substandard drugs, hence the focus of high quality medicines.”
Under the initiative, the standards-setting organisation will provide program management, funding for technical staff, reference standards, and samples. Part of wider plans also includes the implementation of an inter-laboratory testing activity, whereby based on samples submitted by the six labs, each will be given a detailed report containing feedback and recommendations.
“This activity allows USP, the organisation that develops the standards, to provide technical assistance to the end-users of the USP-NF monograph standard, thus helping to ensure the quality of medicines in this region of the world,” Heyman said.
‘Strength in numbers’ to set quality medicines standards
The issues the Network sets out to address were again raised by USP CEO, Roger Williams at the forth Joint International Symposium in Hangzhou, China. He said patients and consumers across the world depend on medicine standards-setting bodies to develop robust standards, and “these pharmacopeial organisations must work together more closely than ever before.”
“All of the world’s pharmacopeias face a variety of technical issues as they try to develop and adopt the kinds of standards that drug regulators, manufacturers, patients, and consumers depend upon to assure quality and safety,” Williams said.
He believes “There is a strength in numbers if we work more closely,” reiterating, “We have an obligation to do that if we are going to meet these urgent public health needs around the globe.”