Korea has become the chairman country of the “Biosimilar Working Group” of the International Pharmaceutical Regulators Forum (IPRF), the Ministry of Food and Drug Safety said Monday.
IPRF is an international group of regulatory bodies created to discuss medicine regulation around the world. The international organization has five working groups that facilitate regulatory cooperation and convergence in various fields of medicine.
The biosimilars working group comprised of 32 members from 11 international regulatory agencies, including the United States and Europe, work together to create the regulatory convergence of technical requirements for biosimilar products.
Korea, appointed the chair country of the biosimilar group, will play a pivotal role in leading the regulatory harmonization of biosimilars until 2019, the ministry said.
As chairman of the committee, the stage agency has prepared a “Biosimilar Cooperative Examination Information Booklet,” which contains guidelines on how to write approved examination results and examples of actual approvals. The ministry has also developed guidance for evaluating the efficacy of biosimilars, the ministry added.
The ministry also announced plans to apply for the Management Committee of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) at its meeting to be held in Switzerland in November.
The ICH Management Committee, which serves for three years and is elected from among active members of the regulatory body, participates directly in decision-making on overall ICH operations, including supervision and budgeting of the expert committee.
The ministry is the first non-ICH country in 2014 to be elected chairman of the Biosimilars Working Group, the ministry added.
"As active members of the biosimilar chairperson and ICH member, active international social activities will help domestic pharmaceutical companies to advance into the world,” a ministry official said. “We will continue to demonstrate leadership in all areas of drug regulation, including drug licensing and follow-up, and strive to enhance the competitiveness of domestic pharmaceutical companies by actively reflecting on our stance at the ICH Conference."
The ministry will hold a briefing session at COEX next Wednesday to share the results of the ICH general meeting and its plans for the pharmaceutical industry.