Friday, November 6, 2026

Pakistan presses Ethiopia to expedite pharma approvals

By Eyasu Zekarias

Pakistan has formally urged Ethiopia to accelerate regulatory approvals for Pakistani pharmaceutical companies, placing pending product registrations and manufacturing plant inspections at the center of recent bilateral trade negotiations aimed at unlocking access to the East African market.

During a high-level meeting in Islamabad, Federal Minister for Commerce Jam Kamal Khan called on Ethiopian officials to address administrative delays that continue to hinder Pakistani exporters seeking entry into Ethiopia.

Minister Khan emphasized that predictable timetables, clear regulatory guidelines, and transparent procedures are essential for building commercial confidence among Pakistani exporters. He noted that securing true market access requires seamless coordination between regulatory agencies, trade officials, and diplomatic channels—rather than simply identifying potential buyers or negotiating preliminary commercial understandings.

The Ethiopian Ambassador stated that he has directly engaged Ethiopian health authorities regarding the backlog of pharmaceutical registrations and received positive assurances that the issues would be addressed. However, officials clarified that these envoy-level assurances do not signify immediate product approvals or facility clearances, which remain subject to formal review by the Ethiopian Food and Drug Authority (EFDA).

To accelerate the process, Commerce Secretary Jawad Paul called for the swift scheduling of an Ethiopian technical delegation to visit Pakistan. The delegation would conduct on-site facility inspections and evaluate manufacturing standards—a required technical milestone for advancing outstanding registration applications. No official timetable or list of approved companies has yet been finalized.

Ethiopia’s regulatory framework requires pharmaceutical manufacturers to undergo rigorous evaluation before products can enter the market. The EFDA mandates that local agents demonstrate strong technical competency and a thorough understanding of submission procedures, yet applicants frequently make errors that lead to applications being returned or rejected before scientific assessment begins.

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