Korean authorities need more time for regulatory review of new drugs

[Source : KRPIA]

The average period for regulatory review to approve novel drugs from multinational pharmaceutical companies in Korea was 314 days in the last 10 years until 2020, which is two weeks longer than the average 300 days between 2008 and 2017, according to the Korean Research-based Pharmaceutical Industry Association (KRPIA) on Monday.

The calculation is based on 235 new drugs from multinational pharmaceutical companies approved between 2011 and 2020.

The time required for marketing approval has steadily increased since 2015 and the main reason for the delay is attributed to rigorous review of good manufacturing practice (GMP) and quality control standards at medical facilities.

To shorten the review period, the government should continue efforts to increase the number of experts for a review task, harmonize international regulations, strengthen cooperation with foreign regulatory authorities and expand the mutual certification system, the KRPIA said.