How to authorize and produce medicines in Africa faster and safer

There is a monthly vaginal ring that can reduce a woman's chances of contracting HIV through sexual relations by approximately 30%.

This ring, which will be manufactured in Africa by the South African pharmaceutical company Kiara Health, has been registered in 11 countries on the continent.

Each of those countries has had to individually review the results of the drug's laboratory tests and clinical trials submitted by the International Association for Microbicides, which developed the ring.

To streamline this process in the future, the secret may lie with an African Medicines Agency (AMA), a fledgling body that will review new medicines and production facilities on behalf of African countries.

They can then decide whether they want to register the products locally, without having to go through the laborious process of reviewing the data themselves or, in cases where a country lacks a regulatory body, wait for the World Health Organization to (WHO) approves a medicine.

The WADA, which is not yet operational and will work on pilot projects over the next year, was officially created on November 5, 2021 as a specialized agency of the African Union, and is based in Rwanda.

So far, of the 55 members of the African Union, 37 have ratified or are in the process of ratifying the agreement creating the new body, including Zimbabwe, Uganda, Namibia, Lesotho, Kenya, Ghana, Senegal, Egypt, Rwanda or Tanzania.

The African agency will focus on drugs for conditions such as heart disease and diabetes, ailments such as malaria and tuberculosis, or tropical diseases that no longer appear frequently in other parts of the world but affect poor countries.

The WADA will focus on medicines for conditions of public health concern in Africa, such as heart disease and diabetes, ailments such as malaria and tuberculosis, or tropical diseases such as schistosomiasis and sleeping sickness, which no longer occur frequently. in other parts of the world, but they affect many poor people on the continent.

Also medications composed of what scientists call “complex molecules”, such as the mRNA vaccine – used for covid – or the three-in-one pill against HIV that contains dolutegravir, tenofovir and lamivudine.

In this case, the substance that creates the treatment or protective effect in the body is composed of different chemical substances that are intelligently combined so that the patient has to take a lower dose or fewer pills, and has fewer side effects.

If the WADA had been fully operational when the HIV vaginal ring became available in 2021, the agency's member countries would not have had to review efficacy data on their own.

Skhumbuzo Ngozwana, CEO of Kiara Health, points out that when the pharmaceutical company begins producing the ring – the exact date is not yet known – the WADA could inspect the manufacturing facilities and make a recommendation for this process, instead of the Teams from each country have to travel to South Africa for this purpose.

In this way, the company could process orders from different countries more quickly, since the quality of its product would be guaranteed quickly and thoroughly.

Ngozwana explains: “A well-functioning regulatory system is the foundation of any pharmaceutical industry;

Above all, it is the safety barrier that protects public health.”

A long and laborious process

Before a drug can be marketed, it must be approved and registered by a country's drug regulatory authority.

This means that, although pharmaceutical companies are the ones that manufacture the drugs, the regulatory body verifies the data that demonstrates the effectiveness of the drug and establishes the rules on its marketing and sale, so that the drugs on sale are safe and work as intended. They suppose they should.

Regulators also need to monitor drug use, investigate reported serious side effects, and review data obtained when changes are made to the drug.

Agency can help reduce circulation of counterfeit medicines in Africa

This is a long and laborious process, for which many African countries lack the necessary knowledge, money or legislation.

A regional regulator, with quality standards, operating methods, documentation and requirements in force, can help speed up the process of evaluating a product and, if it gets the green light, transfer it to the local authorities of a country to decide if they want register it.

This means that citizens will have access to new medicines sooner and will not have to wait for an organization like the WHO to approve a drug – which can take a long time – for it to be available in their country.

Having a central medicines agency does not necessarily mean that, if a drug passes evaluation, countries are obliged to have it in their pharmacies.

Member States may decide whether to accept WADA's recommendation and, if so, what information should be included in the product leaflet or packaging.

Another positive effect of the new agency could be the reduction in the circulation of counterfeit medicines, as long as the drug registration system is rigorous, with strict quality controls, and as long as there are WADA officials who monitor how the products are used in the region, says the director general of the South African Health Products Regulatory Authority (SAHPRA), Boitumelo Semete-Makokotlela.

Rich countries that pay more

Once a country has ratified the WADA treaty, the new member will have to pay annual membership fees, which will be calculated based on the size of its economy.

This means that rich countries pay more for membership than poorer countries.

Additional funds will come from fees that pharmaceutical companies have to pay the agency to process their applications and from donors.

Only countries that have ratified the treaty and are paying members will be able to use WADA reviews to register medicines.

The idea behind creating a shared medicines regulator for Africa is similar to that of the European Medicines Agency (EMA) in that people and goods can move freely between countries that are part of the Schengen area, says Chimwemwe Chamdimba, who directs the Harmonization of Medicines Regulation program in Africa and will coordinate the process of creating the WADA until a director general is appointed for the organization.

But the African Medicines Agency will not be an exact copy of the EMA, he says.

“We are learning from what has already worked.”

A longer version of this report was originally published in English in

Bhekisisa

, a South African health publication.

The Bhekisisa Center for Health Journalism

newsletter can be found

here.  

You can follow

Planeta Futuro

on

X

,

Facebook

,

Instagram

and

TikTok

and subscribe

to our newsletter

here

.