Strengthening an Already Vibrant Sector: USAID Support to Jordan's Pharmaceutical Industry
SUCCESS STORY: Savvy Pharma
With USAID Support, Jordan’s Pharmaceutical Exporters Secure Market Acsess
Savvy Pharma is one of six Jordanian pharmaceutical companies that have installed new drug registration software with support from the USAID Jordan Competitiveness Program (JCP). The electronic Common Technical Document (eCTD) system, which is used by regulators in several of the countries where Savvy exports its products, has helped these manufacturers reduce registration times and increase exports. Some are also considering expanding to new markets.
“Previously, we could not export to the EU [European Union] or any country where submission through the eCTD system is a requirement,” explains Dr. Ahmad Al-Ghzawi, Savvy Pharma Managing Director. Installation of the eCTD system, which was carried out in partnership with the Jordanian Association of Pharmaceutical Manufacturers (JAPM), “has created many commercial opportunities for Savvy and has significantly increased the company’s revenues,” he added.
The numbers back him up. Since installing the USAID-supported eCTD system, six Jordanian pharmaceutical companies have reported an additional $55,620,000 in exports. That’s a remarkable achievement by any measure, but it’s even more impressive given the state of the pharmaceutical sector when JCP was launched five years ago. At the time, the industry was constrained by regional conflicts, including in Iraq and Syria — traditional trading partners whose borders were effectively sealed by ongoing violence — and the loss of other markets, like Libya and Yemen, to war.
At the same time, Saudi Arabia, one of Jordan’s largest trading partners, had made eCTD registration a requirement for imported drugs, crowding out Jordanian firms without the means to install and operate the system. Since Saudi Arabia is regarded as a gateway market, that restriction also limited companies’ access to other lucrative opportunities in the Gulf Cooperation Council (GCC) countries.
“Saudi Arabia is considered a major market, and it’s always the target for most pharma companies,” explains Al-Ghzawi. “Since eCTD is required there, though, we could not submit any drug files without this software, and we could not penetrate other GCC countries.”
Although Al-Ghzawi says that his company had worked through an agent in Saudi Arabia to complete the electronic submissions, having the eCTD system installed in-house made the whole process more efficient.
“Manual submissions in general slows down the process, especially when responding to any deficiencies in an application,” he adds. “Now that we can work directly in the eCTD system, we can be sure of what is submitted and included in the file.”
The reduced preparation times have also helped Savvy Pharma cut costs and add new employees. Starting with a staff of only 40, it has added two new team members since installing the eCTD system — growth that Al-Ghzawi hopes to multiply as he and his team eye new markets in Europe and beyond.
“My team is very passionate, and I believe they’re the ones behind this success,” he adds. “To us, the sky is the limit; in the last three years alone, we have registered 47 new products in various countries.”
In addition to assisting Jordanian companies to register drugs through the eCTD system, JCP has helped the country’s pharmaceutical sector clear a backlog of drugs awaiting registration; strengthen the JAPM and Jordan Food and Drug Administration (JFDA) through capacity building, workshops, personal coaching, and technical assistance; and reform regulations and processes to support drug manufacture and export.
“We’re very grateful for USAID’s continuous support,” Al-Ghzawi stresses. “The eCTD system has created many commercial opportunities for Savvy and has significantly increased the company’s revenues, creating a domino effect that is allowing us to register in many new countries. Without this support, it would’ve taken Savvy much longer to reach these markets.”
JCP's support to Jordan's pharmaceutical industry extends to the private sector as well as to the Jordan Food and Drug Administration (JFDA). On April 4, 2017, USAID signed a partnership agreement with the JFDA to expedite and streamline the drug registration process to reduce the time to market for Jordanian medicines, including automation of the drug registration process and capacity-building of JFDA staff. Speaking at the signing ceremony, USAID Mission Director Dr. Jim Barnhart noted that “pharmaceutical companies sell 80 percent of their production to more than 60 countries worldwide, representing nine percent of Jordan’s total exports.”
JCP’s work with the JFDA is ultimately about benefitting the wider Jordanian economy, but we also work directly with the pharmaceutical sector's leading business association, the Jordanian Association of Pharmaceutical Manufacturers (JAPM), to institute an electronic drug registration and application system aimed at reducing the time to market for these products -- thus making the entire sector more competitive. This system will interact seamlessly with a parallel one at the JFDA, which was also supported by JCP. In fact, the JFDA has already successfully rolled out a live version of the new electronic Common Technical Document (eCTD) review tool and initiated the pilot testing of the system with five drug dossiers followed by a second pilot phase ahead of the system's full public launch, scheduled for March 2019.
Check out this video to learn more about USAID's work with the Jordanian pharmaceutical sector: