A recognized “bio expert” has recently become the director-general of the Biopharmaceuticals and Herbal Medicine Bureau at the Ministry of Food and Drug Safety (MFDS), raising high expectations among related industries.

New Director-General Kang Seok-yeon, who took the bureau head’s post early this month, is a specialist who had accumulated experiences in the biotech field, including biopharmaceuticals and cosmetics, since he joined the ministry.

Kang Seok-yeon, director-general of the Biopharmaceuticals and Herbal Medicine Bureau at the Ministry of Food and Drug Safety, explains the bureau’s administrative plan, in a recent interview with Korea Biomedical Review.

Even for an expert, however, the head of the Biopharmaceuticals and Herbal Medicine Bureau is not an easy post. A pile of administrative tasks is awaiting him. A case in point is the “Revision Bill for Advanced Regenerative Medicine and Biopharmaceuticals” pending at the National Assembly. Civic groups are opposing the amendment of the existing law, maintaining some parts of the bill, such as fast-track review of up-to-date biopharmaceutical drugs, will threaten the safety and life of the public while increasing medical costs unnecessarily.

“We need to meet with civic activists. The revision bill intends to authorize the state to control cellular and genetic treatments within a certain frame, but there are differences of views with civic groups,” Director-General Kang said. “Even if the ministry satisfies itself with the smaller authority than initially thought, it needs to speed up the legislation. The National Assembly’s approval of the revision bill will likely give the wings to Korea’s biopharmaceutical industry. I hope it will pass the parliament within March.”

Kang also commented on the stock market disturbances by some biopharmaceutical companies.

“Most companies are sincerely researching and developing, but a few bad apples have tainted the image of even bona fide firms. However, our ministry has no administrative power to control them directly. It is the duty of the Financial Supervisory Service (FSS),” the director-general said. “Thankfully, the ministry signed a memorandum of understanding with FSS last year. If the financial regulator request for information, we will actively provide it.”

Kang said the ministry is also making efforts to beef up evaluating workforce as continuously requested by the biopharmaceutical firms, and has created a consensus with the Ministry of Economy and Finance and the National Assembly on the need to increase examiners.

“In the past, the private businesses used to ask for the quick licensing procedure while submitting as little materials as possible. Now, they are calling for increasing evaluating workforce to meet global standards,” Kang said. “These companies need to go abroad to seek development funding they cannot raise at the domestic market and have realized foreign regulators will reject their requests if related data are insufficient.”

Director-General Kang noted that it is more desirable to increase the numbers of evaluators and related officials in an optimal ratio rather than expanding the evaluating workforce alone. Only when the government officials who can lead and control post-evaluation procedure increase, will the smooth reviewing process be possible, he said.

Kang explained about his plan to support domestic biopharmaceutical products’ advances abroad.

Currently, the World Health Organization is moving to expand pre-qualification (PQ) Certification to pharmaceutical and biosimilar products. PQ Certification is a system, in which WHO screens and certificates the quality, safety and efficacy of medicinal goods to supply them to developing countries. Only medicine and medical supplies that receive PQ Certification can take part in public tenders hosted by U.N. and other international organizations.

Thanks to the excellent performances of Korean companies that have received PQ certification for their vaccine products, more than 70 percent of the nation’s vaccine exports are the products that have won such certifications. If the PQ certification is expanded to include pharmaceutical and biosimilar products, it will open the way wider for the exports of Korean medicines.

“Our ministry is helping the domestic businesses receive WHO’s PQ certification. As we have maintained a good relationship with WHO, a network connection is also possible. Also, we are providing regulatory data of foreign countries targeted by Korean companies,” Kang said.

He also emphasized that the ministry is striving to streamline overlapping regulations in keeping with the regulatory reform campaigns conducted by the Moon Jae-in administration.

“As the result of hard work by biopharmaceutical companies, some companies have begun to produce results. Samsung Biologics and Celltrion, for example, have shown their potential clearly. There have been long rumors about their emergence, and we are now witnessing they are true. Other companies also have potentials. We are not behind other countries but still is somewhat lacking in infrastructure for the biopharmaceutical sector,” Kang said. “In that regard, I think I certainly have a role to play as the head of the Biopharmaceuticals and Herbal Medicine Bureau.”

lhs@docdocdoc.co.kr

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