MCAZ in Global Benchmarking Tool Maturity Level 3 Upbeat Mode

With the Vice President and Health and Child Care Minister Dr Constantine Chiwenga exhorting the Medicines Control Authority of Zimbabwe (MCAZ) to attain the World Health Organization (WHO) Global Benchmarking Tool (GBT) Maturity Level 3 by year end, the authority says it is well on course as they are now waiting for reassessment.

By Kuda Pembere

Speaking at the MCAZ Annual General Meeting in Harare on Friday, VP Chiwenga said this GBT is important as it guides regulatory programs of various medical products such as medicines, vaccines, blood products, and medical devices.

“I am aware that the Medicines Control Authority of Zimbabwe is geared to attain the World Health Organization (WHO) Global Benchmarking Tool, Maturity Level 3 (ML3). I challenge you to achieve this important goal by end of this year. The Global Benchmarking Tool is designed to benchmark the regulatory programmes of a variety of product types, including medicines, vaccines, blood products, and medical devices,” he said.

He noted that MCAZ was given Maturity Level 2 following the WHO Assessment in May this year.

“You may recall that a team of World Health Organisation assessors were in the country in early May this year to assess the regulator. After the assessment, the Medical Control Authority of Zimbabwe was granted Maturity Level 2 with some recommendations to implement.

“It is only after the implementation of those recommendations, that the country will attain Maturity Level 3. I am informed that the Medicines Control Authority of Zimbabwe and the World Health Organization have been in constant communication as the Authority works towards meeting the World Health Organization’s recommendations.

“It is my hope that after this exercise the country will be granted the Maturity Level 3. Maturity Level 3 confirms a stable, well-functioning and integrated regulatory system is in place and, the Government stands ready to work with the Medicines Control Authority of Zimbabwe to make this a reality,” he said.

MCAZ Director-General Mr Richard Rukwata explained how regulatory authorities are assessed.

“The way the process works is that for you to reach maturity level 3 for example, you have to score a minimum of three in all the parameters. So, the way it works is if you score seven, but one I still at maturity level one, you are still considered to be maturity level one.

“So, the lowest score determines your maturity level. So, what happened at the May assessment is that of the eight parameters, we had six at maturity level 3. So, we have two that are outstanding at Maturity Level 2. So, these are what we have been working on,” he said.

He said they have been working tirelessly to resolve the outstanding issues between May and August.

“That is what we have been working on from May to end of August where effectively we believe we have resolved all the outstanding issues. But have to give them time to regroup because the assessors are from all over the world even though it is coordinated by the WHO itself.

“So, we are hoping that when they regroup and look at the outputs of our remedial actions that they will then confirm that we are now at level 3. In the region, only in SADC only Tanzania has reached Level 3 Maturity for general medicines. South Africa is at Level 3 but for vaccines. Everybody else like us we are all working progressively towards the objective attaining level 3,” he said.

The 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 will be eligible for inclusion among WHO-listed authorities, after additional evaluation of their performance.


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