Jamaica's drug registration backlog: 400 medicines waiting

More than 400 molecules in the queue

For Jamaican physicians, a drug that is not registered locally is a drug they cannot routinely prescribe, because unregistered products cannot be routinely imported, distributed or sold in Jamaica¹. That is why a number given at a shareholders' meeting in July 2026 matters at the bedside. Speaking at the annual general meeting of Seprod Group, AS Bryden Group CEO Paul Scott said that its pharmaceutical distributor, Bryden Pi Limited, has more than 400 molecules awaiting registration with the Ministry of Health and Wellness¹. According to the Jamaica Observer, the products include newer hormone replacement therapies for menopause and the latest breast cancer drugs, and Scott said some breast cancer drugs available in Jamaica are five generations behind those used internationally (he did not name the drugs or define a generation)¹.

Scott's argument was about price as much as access: "The more drugs available, the more competitive the tender system. Therefore, lower costs"¹. A distributor with products waiting to be approved has an obvious commercial interest, and the 400 figure covers one company only. But the complaint is not new and not his alone.

A decade of complaints from the pharmaceutical industry

In December 2024, three listed pharmaceutical companies blamed the registration process for weak results. Indies Pharma CEO Dr Guna Muppuri told The Gleaner: "You have to blame the drug registration process at the Ministry of Health. This has completely come to a grinding halt"⁴. R A Williams CEO Audley Reid said the pace at the ministry, through the Standards and Regulations Unit, "has been slow", and Medical Disposables & Supplies CEO Kurt Boothe described regulatory staff who are dedicated but "undermanned to handle the years of increased filings", adding that "new drugs are unable to be offered to our patients for periods of years at a time"⁴. Industry sources told the paper that approvals of new generics could take six months, several months longer than before⁴.

The history goes back further. In April 2016 Health Minister Dr Christopher Tufton told a Jamaica Chamber of Commerce luncheon that a small staff handled registration by hand, completing up to 400 applications a year, and promised: "I am committing to you that we are going to do something about that…to hasten that process and remove the long wait"⁵. In March 2019 he announced a review to modernise registration, including digitising records to shorten the average time to register a drug⁶. Drug registration is the main regulatory function of the Ministry's Pharmaceutical and Regulatory Affairs Department and involves an in-depth scientific evaluation of the technical dossier before a licence is granted⁶.

What the Ministry of Health and Wellness says

The Ministry's answer is that much of the delay starts with the applicant. At a pharmaceutical symposium in Kingston on 19 March 2026, the Ministry said almost 70 per cent of dossiers are held up by incomplete information; from July to December 2025 there were 191 attempts to submit dossiers and only 70 were accepted, most of the rest failing because of poor preparation, incomplete documents or failure to meet requirements². Dr Tufton conceded the process itself is part of the problem: "The application process is manual, and there is always a need to get further clarity", and "We have a challenge and we have to fix it"². He told the same audience that "the quality, completeness, and accuracy of these dossiers are fundamental", and Sean Moncrieffe, Chief Technical Director of the Standards and Regulation Division, told industry "we recognise the challenges you are experiencing"³.

The fix on the table: digitisation and reliance

The plan announced in 2025 and repeated in 2026 has three parts. First, digitising registration so that online forms flag missing documents in real time, with the Ministry saying in March 2026 that it would go to market for an outside technology provider in the new financial year². Second, a fast-track pathway for drugs already approved by stringent regulators; the Observer named the US, UK and EU regulators as the reference points, and Dr Tufton described the mandate as "to use the five advanced jurisdictions that already have a robust system of approval"¹². Third, an express approval window for locally manufactured products¹. The UK supported the March symposium after an October 2025 trade mission that included staff of the Pharmaceutical and Regulatory Affairs Branch, and the Jamaica Chamber of Commerce president welcomed the Minister's commitment "to accelerate the application of the Reliance methodology"³.

Reliance is not an exotic idea. The World Health Organization (WHO) published good reliance practices in 2021 to let regulators leverage "the output of other regulators whenever possible", with the aim of "improving and expediting access to quality-assured" medical products¹¹¹². The Caribbean already has a regional version: the Caribbean Regulatory System (CRS) at the Caribbean Public Health Agency (CARPHA) reviews medicines that have already passed a trusted regulator and recommends them to member states, which then decide on registration themselves⁹. An evaluation of 21 CRS approvals, co-authored by CRS staff, in 2017 and 2018 found a median total approval time of 57.5 days in 2017 and 148 days in 2018, with the slowdown blamed on staff limits, and recommended that member states build legal frameworks to take up CRS recommendations quickly¹⁰.

Why it matters in the clinic and in the budget

Registration delays do not stay in the regulator's office. The World Bank's Jamaica Health Public Expenditure Review for 2016 to 2022, presented to Parliament by Dr Tufton on 3 November 2026, reports progress in infrastructure and staffing alongside rapidly rising medicine costs, and non-communicable diseases account for close to 80 per cent of deaths⁷. Opposition health spokesman Dr Alfred Dawes cited the same review's findings on rising medication costs and called for quarterly publication of indicators that include medication availability⁸. If Scott is right that more registered products mean more competitive public tenders¹, the registration queue is also a procurement cost. For physicians the practical consequence is simpler: the newest version of a drug a patient reads about may not be one that can be lawfully supplied in Jamaica yet.