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Strong regulatory system necessary for quality medicines, vaccines in low income countries — Prof. Mojisola Adeyeye

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Only a strong regulatory system would guarantee and accelerate the development, approval, and access of safe and effective quality therapeutic medicines and vaccines in low, medium income countries of the world, Prof Mojisola Adeyeye, has said.

The Director General, National Agency for Food and Drug Administration and Control (NAFDAC) made the assertion while speaking at the hybrid University of California San Francisco UCSF)-Stanford Centre of Excellence in Regulatory Science and Innovation, (UCSF-Stanford CERSI) summit in the United States.

Speaking as the only panelist selected from Africa at the summit with the theme  “Building a Global Vision for Product and Drug Development: Challenges and Opportunities,” Prof Mojisola Adeyeye, admonished nations on the premise of strengthening of regulatory system in compliance with the World Health Assembly Resolution 67.20 of 2014 in order to build the capacity of member states with the ultimate goal to have access to quality medicines to different low, medium income countries.

She said the WHO supports member states in reaching and sustaining effective regulatory oversight of medical products through the regulatory systems strengthening RSS programme.

She explained to the global audience how NAFDAC under her leadership used the WHO Global Benchmarking Tools to achieve the Maturity Level 3 WHO Certification Status in March 2022 and its significance to Nigeria.

“Using U.S. FDA as reference which is categorised as Maturity Level 4,” she said, “you cannot get Maturity Level 3 without taking care of all the indicators under Levels 1, and 2. You cannot get Maturity Level 4 without taking care of all the indicators in ML1, ML2 and ML3.”

Speaking on “Global Benchmarking Tool and Access to Medicines” at the annual global event, Prof Mojisola Adeyeye noted that there is no 95 or 99 percent in terms of WHO Global Benchmarking.

She noted that the GBT essentially facilitated NAFDAC to identify weaknesses and strength in licensing of products, in the manufacturers and distributors compliance, in how effective is our post marketing surveillance — are we doing containment of market control in terms of illicit trade, are we doing well in terms of regulatory inspection; Good Manufacturing Practice compliance, are the manufacturers adhering to that? How good are our laboratories?

In a statement by NAFDAC media consultant, Sayo Akintola, in Lagos on Wednesday, Prof. Mojisola Adeyeye, disclosed to the summit that NAFDAC was benchmarked on seven functions plus licensing establishment which is under the Pharmacy Council of Nigeria (PCN) jurisdiction, stressing that both agencies were benchmarked together.

She said the Agency met and satisfied 268 indicators and 860 recommendations, adding that the 268 indicators were distributed under Maturity Levels 1, 2, 3, and 4.

“We were able to attain Maturity Level 3 after meeting   all the requirements. We were declared in March 2020.”

She however, noted that attaining Maturity Level 4 would not be too difficult, adding that “some of the standards or indicators we have already met.” She said her Agency is working round the clock as she has already set out targets for Maturity Level 4.

According to Prof Mojisola Adeyeye, there is what is called the World Listed Authority where it’s almost like a specialised grouping, adding that part of Maturity Level 4 indicators also applies to World Listed Authority.

“We are working for both in order to ensure that our system is well established and stable and well-functioning as a regulatory agency.”

In low middle income countries, she said testing is sacrosanct unlike FDA where products are not tested because the system works. In low middle income countries, she added that testing has to be conducted because of propensity for substandard falsified medicines.

The NAFDAC boss pointed out that commitment from top management of the regulatory agencies is required to get Maturity level 3 which is the minimum required in terms of well-functioning and stable regulatory system.

“I took over as DG NAFDAC in November 2017. Right from the beginning my experience in the U.S. in terms of Quality Management System was brought to bear. We committed to Global Benchmarking using Quality Management System as a baseline.”

Prof. Mojisola Adeyeye however, emphasised the importance of reliance for different regulatory agencies in the world. She said reliance represents a smarter way of regulating medical products through collaboration, shared knowledge, experience, and resources. The Reliance is among the different functions such as regulatory inspection, lab testing, clinical trials, market authorisation, pharmacovigilance, market control and licensing establishment.

She further explained that there is a lot of reliance within different functions and there has to be a reliance between agencies, adding that agencies have to collaborate, identify weak links and leverage on the experience of others, mentor other MNRAs.

She said that NAFDAC is doing that right now in terms of Traceability and GBT, noting that Reliance is also facilitated within the West African region and between regions.

“Uganda came to us, and we have been interacting on different aspects of our regulatory activities. Reliance promotes good regulatory practices which is the focus. It helps bring trust amongst NRAs and allow NRAs to seize the opportunity to strengthen themselves.

“It’s extremely important to strengthen the regulatory system. There cannot be local manufacturing without a strong regulatory system. As far as NAFDAC is concerned we use a lot of tools to ensure that our products are more affordable and are of high quality using different GMP inspection.”

She disclosed that the Agency employs detection devices to get rid of infiltrations in the supply chain.

“We use enforcement. We work with Interpol, The FBI and of course, we use vigilance within the country and outside the country. NAFDAC is now known using traceability Track and Trace GS1 to monitor falsified medicines. We used that for vaccines during the Pandemic.”

She opined that clinical trials could be optimised to make medicines and vaccines affordable and affordable to the low, medium income countries. She disclosed that Nigeria is fortunate to be funded by the Gates Foundation in terms of using Design Assessment and Community approach to develop our clinical trials data base or platforms.

She however, said that the importance of informativeness cannot be over-emphasised because it has to be subject-centric.

“If we do not consider the subject when we are designing or during the course of study then it’s very likely that a low percentage of success rate will be achieved.”

She said the Agency started using the DAC system in 2019 just before the Pandemic “and we have our own electronic clinical application platform.”

For research funders and investigators, she said using the informative approach mitigates risks; it’s hypothesis-driven, it increases likelihood of moving an intervention to a cure. It also ensures that there is confidence that is built in them.

She commended the community involvement, stressing that it helps in no small measure.

“We were quite successful in that particular clinical trial that culminated in us getting an IND approval from the US.”

The event was UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) fourth annual Innovations in Regulatory Science Summit, a gathering of leaders in the academia, industry, and regulatory sectors to discuss the role of regulatory science in medical product development.

Other members of the panel of discussants included, Emer Cooke, MBA – Executive Director of the European Medicines Agency (EMEA); Frank Gupton, PhD – Floyd D. Gottwald, Jr. Chair in Pharmaceutical Engineering and Chair, Professor, Department of Chemical and Life Science Engineering at Virginia Commonwealth University;  Peter Marks, MD, PhD – Director, Center for Biologics Evaluation and Research (CBER) at FDA; Jacques Mascaro, PhD, MBA – Senior Vice President, Global Head of Oncology Regulatory Science and Strategy at AstraZeneca.

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WHO to begin vaccination against Human Papilloma Virus May 27 in Kogi

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The World Health Organisation (WHO), says it plans to commence vaccination against Human Papilloma Virus (HPV) on May 27 in Kogi.

The state’s Team Lead of WHO, Dr Muktar Toyosi, said this when he led his team on an advocacy visit to the State Council of the Nigeria Union of Journalists (NUJ) on Wednesday in Lokoja.

Toyosi said that the vaccination was meant for girl child of between the age nine and 14.

He said the ongoing sensitisation was to keep the people informed, and educate them on the vaccination of their children to protect them against cervical cancer in future.

”Kogi falls within the second phase of the programme. We are soliciting for the cooperation of the media in educating the people of the state on the HPV vaccination.

“There need for girls child across the state to take the vaccination to safeguard their future.

“Although the vaccine was initially scarce and difficult to get, the good news now is that it has been made available by the government,” Toyosi said.

Also speaking, the State Technical Assistant for WHO, Dr Ahmed Attah, said that the HPV mostly affect women, adding that the vaccination remained a preventive measure against the disease.

Attah, a former state Chairman of the Nigeria Medical Association (NMA) and a former Chief Medical Director (CMD), Kogi Specialist Hospital (KSSH) Lokoja, urged parents and guardians to avail their children of the vaccination to justify government’s investment.

In his response, the Kogi NUJ Chairman, Mr Seidu Ademu, described the health sector as very critical, stressing that the vaccination was a right step in the right direction.

Ademu promised a robust partnership with WHO to enable the team to achieve its set goals.
He stressed the need to inform, educate and sensitise the general public on the need to embrace the vaccine by ensuring that girls within the age range were vaccinated.

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NCDs will be leading cause of mortality in Africa by 2030 – WHO

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The World Health Organisation (WHO) says Non-communicable Diseases (NCDs) will become the leading cause of mortality in Africa by 2030 if urgent measures are not executed by member states.

Dr Matshidiso Moeti, WHO Regional Director for Africa, joining virtually, made the assertion on Tuesday at the opening of the first International Conference on PEN-Plus in Africa (ICPPA 2024) in Dar es Salaam, Tanzania.

The ICPPA 2024, holding from April 23 to April 25, is aimed at addressing severe NCDs in Africa.

It is being hosted by the WHO Regional Office for Africa, Helmsley Charitable Trust, and the United Republic of Tanzania. Moeti urged member states to embrace strategies that would help to address the issue.

“We are faced with non-communicable diseases and data from low and middle income countries show that 26 per cent of total health spending was due to NCDs, second only to infectious and parasitic diseases.

“Meaning it is urgent to give these often overlooked diseases priority attention as Africa is severely affected and more than in any other place in the world.

“The surge in the burden of NCDs on our continent over the past two decades, is driven by increasing incidences of risk factors, such as unhealthy diets, reduced physical activity, obesity, and air pollution.

“NCDs are set to overtake communicable, maternal, neonatal and nutritional diseases combined as a leading cause of mortality in Africa by 2030.

“And here, the NCDs are called silent epidemics. Unfortunately, this rapid devolution, with a higher mortality rate has not been recognised in the region, because we’re not investing adequately in detecting and lowering the burden of these diseases,” Moeti said.

Moeti noted that severe NCDs like type one diabetes, rheumatic heart disease, and sickle cell disease more frequently affect children and young adults in the majority of Africans population.

She advised that Africa must show increased commitment in addressing NCDs with adequate and sustained resources.

She also said there was the need to strengthen accountability and assess the impact of interventions by enhancing surveillance and monitoring.

According to Moeti, this can be achieved using reliable and timely data at national and sub national levels to drive policy and action as we move forward.

Ms Elke Wisch, UNICEF Representative to Republic of Tanzania, said that collaboration was at the heart of collective response to tackling NCDs.

“Today’s gathering underscores the urgency and importance of addressing NCDs comprehensively and collaboratively.

“The WHO package of essential non communicable  interventions for PEN, for primary healthcare and low resources settings, and the recently launched regional strategy on PEN-Plus provides a strategic framework  for tackling NCDs at their roots,” she said.

Also speaking, Ummy Mwalimu, Minister of Health, Tanzania, said that non communicable diseases NCDs, have become a formidable threat to the health and wellbeing of “our people.”

She urged for collective efforts to address these threats.

“They are silently affecting the lives of our citizens, our communities, undermining the progress we strive to achieve as a nation.

“The impact of these diseases extends beyond individual suffering.

“It affects our communities, our economy, and ultimately the future of our nations in our continent.

“Yet, in the face of these challenges, we are not discouraged together. We have chosen to confront these non-communicable diseases.’’

She urged for lifestyle change as positive way to combatting the negative outcomes of NCDs.

James Reid, Programme Officer for the Helmsley Charitable Trust’s Type 1 Diabetes (T1D) Programme, said he was happy at the level of interest and momentum in engagements to address NCDs, especially Type 2 diabetes.

He, however, identified finance as one of the biggest challenge and hindrance. He said that while political leaders and stakeholders identify the challenges that NCDs pose, the strategies to prevent them, especially NCD care, were limited.

“Leadership for driving of PEN-Plus is very important to make sure that ministry of health leaders and all others involved, really understand how to change the dynamics as well as adopt solutions to suit specific localities,” she said.

WHO’s PEN-Plus (Package of Essential NCD-Plus), is a regional integrated care delivery strategy to address severe non-communicable diseases at first-level referral health facilities.

At the 2022 WHO Regional Committee Meeting for the African Region, the 47 Member States of the AFRO region voted to adopt the PEN-Plus strategy.

It is focused on alleviating the burden among the poorest children and young adults. This is by increasing the accessibility and quality of chronic care services for severe NCDs including Type 1 diabetes, rheumatic heart disease, and sickle cell disease.

 ICPPA 2024 provides opportunity to shore up international support for scaling up PEN-Plus in the African Region. Also, the conference serves as a platform to raise awareness of severe NCDs, share lessons from countries implementing PEN-Plus and identify opportunities to strengthen NCD management.

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UNICEF emphasises importance of polio vaccination to caregivers

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The United Nations Children’s Fund (UNICEF) has encouraged caregivers in Katsina, Kano and Jigawa States to present their eligible children for the next round of polio vaccination exercise.

Mr Michael Banda, the Officer-in-charge of UNICEF Kano Field Office, made the call in Kano at a media dialogue on the polio campaign on Friday.

The media dialogue was organised by UNICEF in collaboration with the Kano State Primary Healthcare Development Agency, with participants from the above-mentioned states.

The News Agency of Nigeria (NAN) reports that the four-day polio vaccination exercise is scheduled to commence on April 20, across the three states.

According to the UNICEF Officer-in-charge of the Kano field office, the importance of the exercise cannot be overemphasised.

“As the data show, in Kano, Jigawa and Katsina, we have over 556,750 children who have not received one single dose of vaccination they should have received.

“These are referred to as zero-dose children. Such children inexorably are vulnerable to vaccine-preventable diseases, including poliomyelitis.

“This is unacceptable and must be tackled frontally. Not only is polio vaccination crucial, but all routine vaccinations are also critical to children’s survival.

“We must all work together to strengthen routine immunisation services and ensure that all children under five receive all vaccines, including the polio vaccine,” Banda said.

He added that, if all children got vaccinated and receive the vaccines they needed to receive, they would no longer be at risk of contracting polio, with attendant debilitating consequences.

He said that, rather they would have received the immunity which would protect them against vaccine-preventable diseases.

Banda emphasised that immunisation had been proven to be the most cost-effective protection against vaccine-preventable diseases.

“Let’s all work together, government, development partners, religious and traditional leaders, communities, NGOs, CSOs and the media, to ensure that every Nigerian child under five is vaccinated.

“This will protect them from not just polio, but all other vaccine-preventable diseases,” he appealed.

According to the UNICEF official, managing misinformation and vaccine hesitancy for Polio and overall vaccination is very crucial in Nigeria to stop the outbreak.

He stressed that the role of the media, including social media, was important in this aspect.

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