Digital Shift in Veterinary Drug Registration Struggles Against Glitches, Gridlock

Apr 27 , 2025. By YITBAREK GETACHEW ( FORTUNE STAFF WRITER )

The veterinary drug registration process moved fully online after the Ethiopian Agricultural Authority (EAA) rolled out a new directive in January 2025, requiring all applications, whether for imported or domestically produced medicines, to be filed through its electronic service system.

Officials believe that formalising the process in digital form would simplify submissions and help the Authority build reliable archives.

“It’s important to clarify this because," said Hailu Zeru, a drug registration and permit officer at the Authority. "We use the guidelines to collect information, even though it’s not considered law."

Under the directive, importers should secure certification before bringing any veterinary drug into the country. Among the requirements is a mandate that a recognised pharmacopoeia, an official publication that sets legally binding standards and quality specifications for medicines, backs every medicine. This publication is limited to those from Britain, the United States or Europe. Drugs sourced from other major suppliers, notably China and India, should demonstrate full compliance with these standards.

The Authority oversees four regional centres in Dire Dawa, Bahir Dar, Hawassa, and central Ethiopia, and has a network of 45 sub-centres. In the five years leading up to the directive, inspectors revoked 28 veterinary-drug certifications and rejected 11 products after on-site inspections, signalling the EAA’s growing emphasis on enforcement.

Historically, 90pc of the veterinary drugs have been imported through over 110 licensed importers, who handle some 68 different types of medicines. Certification entails a multistep review, including evaluation, laboratory testing for quality and safety, and inspections of foreign manufacturing facilities. Companies submit proof of good manufacturing practice compliance, an original certificate for the pharmaceutical product, and, where relevant, pesticide product certificates.

In the nine months, 2,850tns of veterinary drugs passed quality and safety inspections, down slightly from 3,043tns in the same period last year. Annual spending on veterinary medicine continues to exceed 45 million dollars.

Yet, the new system has exposed technical weaknesses that threaten to upend the very efficiencies it seeks to deliver.

Rainoff Trading Plc, one of the largest importers, has struggled with repeated server outages and sluggish file uploads.

“We’ve been trying to upload a file for over 10 days without success,” said Natnael Mekonnen, the company’s general manager.

When importers split large submissions into multiple parts to meet the system’s 10 megabyte limit, they often encounter misstaging errors that further delay review. In some cases, timelines to recieve  certificaitons for drug inspection  extend upto two years.

Others warn that the shift to electronic registration may carry unintended risks. Because the directive accepts pharmacopoeias from Britain, the United States and Europe without additional scrutiny, substandard or counterfeit drugs could slip through if the system fails to verify their provenance.

According to Dagninet Yimenu, a veterinary importer and pharmacist, digitising the registration process is a step forward.

"But, adaptation remains a challenge,” he said, noting that after submitting applications, he often waits more than two weeks without any response. "Bank payment integrations have slowed so seriously that routine transactions now drag out over several days."

Despite these complaints, the Authority's officials frame the system as an opportunity to broaden local drug manufacturing. Hailu believes e-service registration will allow producers to register new medicines directly, reducing dependence on importers of established brands. He argued that while routine products may queue at the end of the line, essential drugs, such as treatments for drought-stressed livestock or postpartum cows, are fast-tracked during emergencies and disease outbreaks.

The Ethiopian Animal Health Institute, which produces vaccines domestically, still relies on imports for more than 85pc of its veterinary drug inputs.

Alemayehu Feyissa, the Institute’s marketing team leader, disclosed local production to have reached upto 10 million boluses annually, roughly half of the Institute’s 20.5 million unit capacity.

“Imported medicines sometimes don’t match the diseases we face locally,” he told Fortune. "The potential benefits of a clearer and more accessible registration pathway for domestic manufacturers are great."

But the Institute’s deputies insist that digital progress should not come at the cost of system dependence.

Berecha Bayissa, the institute's operational deputy director, welcomes the clear framework but urged that keeping a traditional option, such as in-person visits, during the transition would have cushioned stakeholders against technical hitches.

Abyssinia Animal Drug Importer & Wholesaler Association represents more than 110 members. Its board member, Sileshi Mekonnen, revealed that inspection fees, which run 4,500 dollars for facilities in Africa and Asia and 6,500 dollars elsewhere, compound the burden on companies already struggling with digital delays. Drugs backed by UK, US or European pharmacopoeias dodge those fees, but the Association's leaders question whether the e-service is functional enough to justify the advantage.

“The online system is good," said Sileshi. "But, the question is whether it is functional and easy to apply through.”

Behind the scenes, the Authority is scrambling to shore up the platform. Officials acknowledge that large scientific papers, which routinely exceed 100 megabytes, cannot be uploaded in one piece, so a stopgap rule allows for split files.

“The system is still a problem for us,” Hailu conceded, even as he touts the benefits of digital storage and reduced inperson visits.

According to veterinary experts, durable infrastructure should match procedural upgrades if the initiative is to succeed.

Elias Demeke, a veterinarian with two decades of experience, working for Eagle Animal Clinic & Drug Shop, praised the system’s interactive features but warned that frequent service interruptions and file size limits could make the process more burdensome than the old manual-based approach.

“They should have skilled personnel, a standby generator and a reliable network,” he said.

Hailu confirmed that IT support and backup power are already in place, and that coordination with regional centres is improving steadily.

PUBLISHED ON Apr 27,2025 [ VOL 26 , NO 1304]

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