Kuwait is regulated by the Ministry of Health. Registration is handled by the drug control administration within the Ministry — and we are going to be careful about naming it, for a reason set out below.
Raised Pharma supports manufacturers and brand owners preparing for Kuwait: CTD dossier preparation, GMP and legalisation documentation, and bilingual labelling.
In December 2025 the Ministry of Health issued a package of eleven ministerial decrees restructuring the governance of medicines, medical products and cosmetics. Kuwaiti press reporting indicates the responsible department has been renamed and given exclusive authority over release and sale approvals, and that a new framework introduces multiple defined registration pathways.
We will not print a departmental name or a pathway list that we cannot verify against a current official Kuwaiti source. Kuwait publishes very little retrievable regulatory guidance in English, and much of what circulates online predates these changes. For any Kuwait engagement we confirm the current position directly with the Ministry before work begins. That is slower than quoting a consultancy blog, and considerably safer.
This is the most commercially important point on this page, and it matters especially to Canadian companies.
Kuwait has operated a reliance-based review under which a product was required to have been licensed and marketed for a period in a country with a recognised competent regulatory authority — with the reference authorities given as the United States, European Union or Japan — before Kuwait would run its abridged assessment. Biological products and biosimilars have been required to hold registration with a competent authority such as FDA or EMA.
If that requirement remains current, a product authorised only in Canada may not be filable in Kuwait at all until it holds a US, EU or Japanese authorisation. That is a sequencing decision, not a paperwork detail, and it should be settled before you spend money on a Kuwaiti dossier.
We flag this as requiring verification: the figure and reference list come from pre-2025 documentation and may have been restructured by the December 2025 framework. We check it per project.
Consular legalisation is where Kuwaiti applications most often stall. Documents that are unauthenticated, or whose authentication has lapsed, do not satisfy the requirement — and re-legalising a document from overseas is slow.
Kuwait has liberalised foreign ownership: since January 2024 a foreign company may open a branch office without a local agent, and wholly foreign-owned entities are possible. That is a commercial-registration matter and does not remove the drug registration requirement for an MOH-licensed local agent. The two are separate. Commercial agency relationships are governed by their own law and must be registered, or Kuwaiti courts will not hear disputes arising from them — a point for qualified Kuwaiti legal counsel.
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Important: General information, not regulatory or legal advice. Kuwait’s regulatory framework was substantially amended in December 2025 and publicly available English guidance is limited and partly superseded. Nothing on this page should be relied on for a submission or a market-entry decision without direct confirmation from the Kuwaiti Ministry of Health. Agency arrangements require qualified Kuwaiti legal counsel. Last reviewed August 2026.