Introduction

In 2009, the African Union Development Agency, the World Health Organization, and multiple partners came together to tackle the pressing need for a more robust and efficient medicines regulatory framework across Africa.

The sluggish medicine registration and approval processes in Africa have long caused significant delays to patients’ access to priority medicines. Weak regulations have also allowed substandard and falsified medicines to enter the market unchecked, posing a serious public health risk.

Their solution was to launch the African medicines regulatory harmonization intiitive (AMRH), an umbrella initiative that will coordinate regional harmonization programs Through Africa’s regional economic communities (RECs).

The idea was if national medicines regulatory authorities within each regional bloc can harmonize their requirements for medical product regulation, coordinate their activities, trust and rely on one another’s assessments, it could significantly enhance regulatory efficiency – and make it easier and faster to register medicines and bring them to market.

In 2012, the East African Community became the first to launch its regulatory harmonization program, resulting in a 40-60% reduction in approval timelines for certain branded medicines—similar efforts spread across other regional blocs, covering most of the continent.

However, when the African Medicines Regulatory Harmonization (AMRH) initiative marked its 15th anniversary in Maputo, Mozambique last November, North Africa remained the only region without a regional regulatory harmonization program. Still, the prospects for regional cooperation are far from bleak, with steps being taken to explore collaborative initiatives.

The Maghreb + Egypt

Late last year, representatives from several African national regulatory authorities, including delegates from North Africa, flew to Cairo to participate in a conference on medical regulations in Africa, hosted by Egypt.

Chimwemwe Chamdimba, head of the African Medicines Regulatory Harmonization (AMRH) program, told The North African: “It was a valuable opportunity to sit down and discuss the prospects of establishing a North African regional program.”

“We emphasized that while the rest of the continent is advancing in regulatory harmonization, this region remains uncoordinated. To move forward collectively as a continent, North Africa must also adopt proper coordination and harmonization,” she added.

A key challenge, however, lies in identifying a suitable platform—a regional bloc—that can support the coordination of such a program in North Africa.

The African Union member states in North Africa are affiliated with multiple overlapping Regional Economic Communities (RECs), including the Arab Maghreb Union (AMU), the Community of Sahel-Saharan States (CEN-SAD), and the Common Market for Eastern and Southern Africa (COMESA).

Of these, CEN-SAD and COMESA primarily include members from West, East, and Central Africa, many of whom are already engaged in other regional regulatory harmonization programs. Moreover, neither organization includes all North African states.

The AMU, which is the primary regional bloc for North Africa, also falls short of inclusivity as Egypt and the AU-recognized Sahrawi Arab Republic are not members. Additionally, its capacity has been severely undermined by long-standing tensions among its member states.

“The AMU was, however, the obvious choice”,  Chamdimba added.

“But then we realized that Egypt has a pivotal role to play, being the only North African regulatory authority with a maturity level 3 on the WHO’s ladder of 4, It will be crucial for Egypt to collaborate with other countries in the region”

As a result, we agreed that we will have AMU+1, which will include Egypt,” she explained.

Tunisia as the interim Secretariat

By mid-2024, a high-level meeting of North African regulatory agencies took place in Tunisia, which offered to host the event.

“All the countries were represented, and the meeting was well attended at a senior level. The chairman of the Egyptian Drug Authority participated alongside the heads of agencies from the Arab Maghreb Union countries,” Chamdimba said.

According to Chamdimba, one of the key outcomes was the agreement to establish a secretariat for the program. Since the AMU acknowledged its lack of capacity, the countries collectively decided to appoint Tunisia as the interim secretariat.

“The appointment of an interim secretariat marks a significant milestone toward establishing permanent structures and governance mechanisms for the program. Additionally, key documents and proposals have been drafted, along with a preliminary timeline for implementation”.

“All we’re waiting for now is for the countries to convene, finalize decisions, and officially launch the project,” Chamdimba explained.

“We were supposed to meet towards the end of this year, but unfortunately, scheduling conflicts have delayed the plans. However, we’ve agreed to reconvene in early 2025,” she added.

It’s also expected that by the first quarter of 2025 the African Medicines Agency (AMA) will be officially operational after the appointment of its director general.

The AMA treaty, which came into effect in 2021, has now been ratified by 28 AU member states, including nearly all North African states.

North African regulators are also part of AMRH technical committees that will be later incorporated into AMA, and are participating in wide range of AMRH activities including a laboratory network to strengthen African National Quality Control Labs’, twining programs with other African regulatory authorities to boost regulatory capacity, among other.

“North Africans are participating in many of our initiatives, this shows how committed they are and they know the benefits of working collectively with other countries on the continent”, Chamdimba said.

“Like any other regional project, the start is never smooth, but we are comforted by knowing that they have decided they will work together, and to take the first step, which they already have done”, Chamdimba concluded.