JFDA 2025-2027 Priorities: WHO Listing, PIC/S Membership and ICH Alignment

1. Key takeaways

The first priority agenda of JFDA for 2025–2027 published by the Jordanian government is to obtain World Health Organization (WHO) regulatory authority listing and to secure PIC/S and ICH membership. GRZAN’s judgement is that this path will keep pushing Jordanian device review standards toward international baselines, producing a two-sided effect for companies: the value of reference-country approvals rises, while local technical thresholds climb.

The second conclusion is that the supporting procedures carry a clear direction of resource investment. The key procedures listed by JFDA include upgrading and updating institutional legislation, accelerating drug registration, equipping laboratories to WHO and PIC/S requirements, upgrading electronic procedures, providing qualified personnel, approving the drug inspection charter and directives as revised in 2023, and establishing and activating an institutional technical quality management system.

The third conclusion is that this forms one of the three differentiated levers GRZAN has selected for the Jordanian market. Companies planning their Middle East footprint across 2026 and 2027 should treat JFDA’s internationalisation progress as a variable of the registration strategy, not as background noise.

• WHO listing and PIC/S and ICH membership form JFDA’s first priority for 2025–2027.
• Supporting procedures span legislation, laboratories, electronic systems, personnel and the inspection charter.
• Reference-country reliance on CE and FDA approvals gains weight as standards converge.
• Local testing capacity upgrades raise the probability and lead time of local sample testing.

2. Legal basis

The agenda and its statutory anchors are as follows.

Provision loci follow the official chapter statement published by the Jordanian General Budget Department; specific provision numbers are subject to the Arabic original texts of the Jordanian Official Gazette.

3. Expert insights

Insight 1: laboratory benchmarking against PIC/S means an upgrade of testing capability. JFDA has expressly committed to equipping its laboratories to WHO and PIC/S requirements. The direct consequence of upgraded testing capability is that the coverage of local testing items will widen, and the cases in which foreign reports were accepted because local capacity was lacking may decrease. For IVD and high-risk device companies, this raises both the probability and the cycle time of local sample submission.

Insight 2: legislative upgrading will change the form of the subordinate documents. JFDA lists “upgrading and updating institutional legislation” among its key procedures. Set against the current architecture of the 2019 circulation criteria, the 2017 registration guidelines and the 2011 GMP guidelines, revisions or replacements of these documents may follow. Companies should add “whether subordinate documents have been updated” to their quarterly review items.

Insight 3: the ICH membership target affects clinical data. The substance of ICH membership is the harmonisation of technical standards. If JFDA converges on ICH standards, the organisation of clinical evidence and the acceptance of CTD-style structures will improve, which is good news for companies that have already completed clinical evaluations in Europe or the United States. It also means that clinical documents drafted to older formats should be reviewed for structural compatibility before submission, rather than forwarded unchanged.

Insight 4: the upgrade of electronic procedures changes the submission mode. JFDA’s second priority is to upgrade the existing electronic systems and develop new electronic services, including automating the work of the devices and supplies directorate and automating the issuance of electronic registration certificates. Jordan already provides electronic appointment and document attachment through the Cosmo system; the degree of electronic submission will keep rising, and the stage of physical submission of original paper documents may shrink.

Insight 5: the internationalisation path magnifies the value of CE and FDA approvals. Reference-country reliance is the core feature of the current Jordanian mechanism — a CE certificate or FDA approval is the principal basis for registration. As JFDA moves toward international standards, the certainty of this reliance route will strengthen further. GRZAN recommends that companies treat obtaining CE or FDA approval as an up-front investment for entering Jordan. The earlier the approval exists, the more of the Jordanian file can be assembled by reference rather than by fresh generation.

4. Practical recommendations

• Treat CE or FDA approval as a precondition for the Jordanian market rather than an option. Under JFDA’s internationalisation path, the value of reference-country approvals can only rise.
• Review JFDA subordinate documents and circulars quarterly. Legislative upgrading is an established procedure, and document updates will surface first at the circular level.
• Reserve cycle time and budget for local testing. After laboratory capability upgrades, the probability that Class IIb and Class III products are required to submit samples to the JFDA central laboratory or the Royal Scientific Society (RSS) rises (practical estimate).
• Adapt to electronic submission early. Require the AR to build electronic document management capability and reduce dependence on physical submission of paper originals.
• Track the internationalisation milestones alongside the product plan, so that laboratory and electronic-procedure changes arrive as planned variables rather than surprises.

5. Verification checklist

• □ Review the latest progress and any newly added procedures under the JFDA 2025–2027 priorities
• □ Confirm whether the product has already obtained CE or FDA approval
• □ Search whether JFDA has issued revised drafts or new directives related to legislative upgrading
• □ Reserve cycle time and budget for local sample testing for Class IIb and Class III products (practical estimate)
• □ Confirm the AR has the capability for electronic document submission and management
• □ Review the Cosmo system workflows with the AR, so that appointment and attachment steps are handled without unnecessary visits
• □ Re-verify the cited provision numbers against the Arabic original texts of the Official Gazette

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Jordanian market. Our team manages Jordan Food and Drug Administration (JFDA) registrations, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com