Government says it is winding up the validation of legislations meant to bring the Medicines Control Authority of Zimbabwe (MCAZ) closer to its desired target of achieving the World Health Organisation’s (WHO) Global Benchmarking Tool (GBT) Maturity Level 3.
By Kudakwashe Pembere
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.
Officiating the MCAZ annual general meeting on Monday, the Vice President who is also the Health and Child Care Minister, Retired Gen, Dr Constantino Chiwenga represented by his Deputy Minister Dr John Mangwiro pledged that his Ministry is keen to approve the legal instruments meant to assist the Authority in carrying its mandate of safeguarding public and animal health.
I am aware several legal instruments need to be amended for you to discharge your duties effectively. In that regard, my Ministry is committed to approving your legal instruments and supporting you as you discharge your mandate.
The government is in the process of finalizing the approval of three pieces of legislation. These regulations are:
1. Medicines and Allied substances (Import and Export of Medical Devices) Regulations.
2. Medicines and Allied Substances Control (Blood and Blood Components) Regulations.
3. Amendment to the Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) Regulations, 2018,” he said.
The VP and Health Minister encouraged the Authority to align the legal instruments with best global trends.
“As you draft your instruments you must ensure that they are in line with global standards and will ensure that you achieve the aforementioned GBT Maturity Level 3 as well as allow you to contribute to the Pharmaceutical Strategy, the NDS1, and Vision 2030,” said VP Chiwenga.
VP Chiwenga commended the medicines and medical devices regulator for its role in the fight against the pandemic.
“I want to applaud the role that the MCAZ has played in the National Covid-19 response strategy.
“The authority made sure that the country rolls out the national vaccination strategy successfully by issuing emergency use authorisations for Covid-19 vaccines and providing scientific recommendations on Covid-19 therapeutics that the country needed to protect its citizens,” he said.
Yet, MCAZ Acting Director General Mr Richard Rukwata said the delay in approving their legal statutes was a hurdle in the Authority’s pursuit of the much-coveted GBT Maturity Level 3.
“And one of the most important aspects that we need help with particularly from our Ministry is the legislation. Our legislation has fallen far behind what is considered as standard from the continental which is the African Union Model Law on regulation of medical products.
“So we have made our submissions to our parent Ministry and those issues are being addressed and we hope that once we go beyond that impediment then we will reach this milestone,” he said.
He cited their quest to attain the GBT Level 3 saw them getting ISO certifications for their laboratories.
“We also like to point out that we had our WHO Global Benchmarking Assessment in the month of August 2021. So MCAZ as you are aware, we are high achievers. We pursue many accolades. Under ISO, we have ISO 9001/2017 which is a management system which we have incorporated into our processes. Then we have ISO 17025 for our labs. The chemistry lab and medical devices lab. And in 2021, we have also retained that as well as the 9001. We have the ISO 17020 for our inspection processes and all those have been retained,” Mr Rukwata said. “However, the world is moving forward and the next target is the WHO process that I am talking about. So, members will know the world has many regulators and regulation particularly of medicines is a jurisdictional issue. Every country has its own regulatory processes. However, regulators have to work together and, in that respect, WHO came up with a benchmarking process from Level 1 up to 4. I have heard that there will be a fifth Level which will be the highest level.”
Mr Rukwata added the Level 3 came with benefits such as attracting vaccine manufacturers in the country.
“But for most of us particularly on the African continent, we believe that achievement of Level 3 is an indication of sufficient maturity for a regulatory authority and it also comes with many other opportunities whereby we can even attract vaccine manufacturers for example. “And also, we can come up with robust systems and processes which can also be shared by other regulatory authorities,” he said.
The Acting DG said, “MCAZ is currently pursuing Level 3 and after our assessment by WHO last year we had to come up with a number of what we call institutional development plans. So, we have moved quite a distance towards the finalisation of this process. But we do have some impediments.
