Health Ministry Moves to Digitise Pharmaceutical Product Registration Process

The Ministry of Health and Wellness is moving to digitise the pharmaceutical product registration process during the new financial year, which begins April 1.

The aim is to ensure greater efficiency in the processing of dossiers submitted to obtain marketing approval, by identifying missing documentation in real-time during online applications.

Currently, almost 70 per cent of dossiers are delayed due to incomplete information.

Portfolio Minister, Dr. the Hon. Christopher Tufton, said that between July and December 2025, there were 191 attempts to submit pharmaceutical dossiers, but only 70 were accepted.

The majority could not be processed due to poor preparation, incomplete documentation, or failure to meet established requirements.

“More often than not, applications have limited or incomplete information, inaccurate information. The application process is manual, and there is always a need to get further clarity,” Dr. Tufton said.

“I am expecting that we will go to market soon for a provider of that digitisation process… which, I think, would address some of the issues of the cause of delay. We don’t do it in-house, so we’d have to get that outsourced,” he pointed out.

Dr. Tufton was addressing a pharmaceutical symposium on Thursday (March 19), at The Jamaica Pegasus hotel in New Kingston.

He noted that 20 years ago, applications for pharmaceutical approvals were a fraction of what they are now.

“We have a challenge and we have to fix it,” he said, noting that the Ministry is also looking at collaborating with other jurisdictions to fast-track the approval of drugs.

“The mandate is to use the five advanced jurisdictions that already have a robust system of approval, and to the extent that these products have been subjected to those standards of approval, it will allow for a much easier passage for approval in Jamaica, and that, to me, will solve a lot of the issues,” the Minister said.

In August 2025, the Ministry’s Standards and Regulation Division, in collaboration with the Jamaica Manufacturers and Exporters Association (JMEA) and the Jamaica Chamber of Commerce (JCC), hosted a client engagement symposium centred on the new vision for pharmaceutical regulation.

The forum provided a valuable opportunity to address key matters affecting the registration of pharmaceuticals. Particular attention was given to the processes surrounding permit approvals, as well as the Jamaica Single Window for Trade (J-SWIFT) system, its challenges and the importance of equipping stakeholders with a clearer understanding of how to effectively navigate the systems.

The Standards and Regulation Division was established in March 1999, under the Health Reform process of the Ministry, to lead the process for quality improvement through standard setting and monitoring of the health sector (public and private).

The core functions are to assess and evaluate narcotics, psychotropics, herbal products and other drugs, cosmetics, foods and medical devices for safe use by the public; assess and evaluate all chemicals for safe application and use by the public; development of healthcare standards and guidelines; monitoring and enforcement of standards, regulations and guidelines; and resolution of complaints in the public health sector.