- Regulator sets up special review team for first-in-class drugs
The Ministry of Food and Drug Safety said it has introduced a “special screening system” to enhance the assessment of first-in-class medicine, which uses a new and unique mechanism of action for treating a medical condition.
Choi Young-joo, director of Drug Review Management Division at the National Institute of Food and Drug Safety Evaluation, explained about the special review system and “Bio Empathy,” a consultative body that promotes communication between the industry and the government.
|Choi Young-joo, director of Drug Review Management Division at the National Institute of Food and Drug Safety Evaluation, speaks to reporters on Tuesday.|
“The Invossa debacle has become an opportunity for the food and drug safety ministry to strengthen its expertise in the drug review system and drug safety,” Choi said. “We sought to improve the evaluation system to enhance these two areas and introduced the special review system.”
Earlier this year, the government revoked the license of Invossa, gene therapy for osteoarthritis, after finding an ingredient labeling error.
Choi said the ministry plans to apply the special review system to first-in-class biopharmaceutical medicines. To do so, the ministry set up a special team comprised of 35 experts who have at least five years of experience in assessing biopharmaceutical products.
“If a company applies for the review of an advanced biopharmaceutical drug, like Invossa, seven or eight reviewers in the special review team will assess it thoroughly,” she said.
The ministry increased the number of reviewers by five and also formed a cross-review team to double-check the review in three areas -- quality, nonclinical study, and clinical study, Choi added.
However, she made it clear that the government cannot verify whether a company submitted false data for a drug. From a reviewer’s point of view, it is the right thing to do to regard submitted data as “true,” she said.
As for criticism that the food and drug safety ministry should expand the workforce for drug assessment, Choi said the government found it difficult to do so.
“When the ministry announced its strategy to support the bio-health industry, it said it would double the number of reviewers for three years. However, it is difficult to increase the number of government officials,” Choi said. “The ministry will make efforts to do so, but it is also searching for ways to utilize external experts.”
The food and drug safety ministry holds an expert meeting if a significant review issue comes up, Choi noted.
The ministry signed a memorandum of understanding with various groups, including the Korean Vaccine Society, the Korean Society for Stem Cell Research, the Korean Society of Gene and Cell Therapy, and the Korean Cancer Association, she said.
“We expect we can get advice on workforce when we make review guidelines or regulatory science from those societies and exchange information,” she added.
The ministry recently created an industry-government consultative body, “Bio Empathy,” to enhance communication during the regulator’s assessment on advanced biopharmaceutical drugs. Bio Empathy consists of officials at the food and drug ministry’s biotech-related divisions, executives of the pharmaceutical industry and related associations.
The ministry’s communication with the industry used to be too focused on addressing a particular complaint, not allowing much room for moving forward, Choi said.
Bio Empathy will be a chance for both the government and the industry to share a big picture and discuss preemptive measures for biopharmaceutical drugs, she added.