The Ministry of Food and Drug Safety (MFDS) should have more budget, increase drug review fees, and nurture the regulatory science industry to address the chronic problem of shortage of drug review personnel, experts said.
Korea Biomedical Review has learned that the MFDS had 305 medical and pharmaceutical product personnel as of the end of March, a slight increase from 228 last year.
However, the number is dwarfed compared with the US Food and Drug Administration’s 8,000 and the European Medicines Agency’s 4,000.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has around 560 review personnel, and Health Canada has about 1,150.
The MFDS is hiring 13 professional tenure civil servants to support the commercialization of Covid-19 vaccines and treatments.
Pharmaceutical industry officials urged the MFDS to raise the number of drug review personnel. In addition, they said the MFDS should enhance professional review competencies to meet its duty as a drug approval / drug review service supplier.
The shortage of the MFDS ‘drug review personnel was repeatedly noted in several conferences, including the New Year conference for nurturing the bio-health industry in early 2022 and the 12th Healthcare Future Forum on Friday hosted by the Korea Health Industry Development Institute (KHIDI) .
MFDS officials are also unhappy about the shortage of personnel.
“The budget is decided by the Ministry of Economy and Finance, and the personnel, by the Ministry of the Interior and Safety. They don’t send civil servants to the MFDS often, ”an official at the MFDS said. “Even if the ministry fills some vacancies, it is not intended for the future. Hiring occurs mostly after a problem emerges. “
According to the official, the MFDS newly set up the New Infectious Disease Vaccine Inspection Division because the existing staff was insufficient to verify the quality of Covid-19 vaccines. Still, staff in the new division are temporary workers, he said.
Some claimed that if just a part of the national R&D budget of tens of billions of won is spent hiring the MFDS ‘review personnel, it will have good effects. In addition, if the increase in the review personnel advances the timing of approval for homegrown Covid-19 vaccines and treatments, it would also generate economic effects.
Another MFDS official emphasized the need to hire physician or pharmacist-turned regular review personnel.
The MFDS ‘shortage of personnel is partly attributed to social and cultural norms in Korea when compared to the FDA, the official pointed out.
In the US, professionals build their careers at the FDA and pharmaceutical companies and raise their salaries.
In Korea, some physicians are interested in the MFDS review positions. Still, the official added that the salaries are low, and they worry that their places at hospitals and companies might be gone after two or three years of work at the MFDS.
At the Healthcare Future Forum on Friday, Jeong Hyeon-cheol, director of the Biopharmaceutical Policy Division at the MFDS, said increasing drug approval review fees and nurturing the regulatory science sector were priorities to recruit the MFDS ‘review personnel.
According to Jeong, the MFDS charges 8 million won ($ 6,455) for reviewing a New Drug Application (NDA). The FDA charges about 3.5 billion won, the EMA, 400 million won, Japan’s PMDA, 500 million won, and Health Canada, 300 million won.
“Korean review fees are a few hundredths compared to other countries,” he said.
Jeong said he even heard a foreign company saying it would pay only 8 million won to get the MFDS ‘quality preliminary review and go to another country to get full approval.
“For the MFDS to provide ‘companion and preemptive’ review, it should increase the review fees dramatically,” he said.
He also said the nation needs legislation to promote regulatory science.
“We need legislation to properly operate the MFDS program on master’s and Ph.D. courses for regulatory science at five universities. “