Korea's food and drug ministry moves to raise drug review fees

The food and drug safety ministry said Friday it will raise the fees it charges drugmakers for product approvals and reviews, with the steepest increases falling on advanced biopharmaceuticals and other medicines that require intensive scrutiny.

Under the draft rules, the approval fee for an advanced biopharmaceutical will rise to 20.7 million won ($15,432) from 8.03 million won ($5,984), the same level proposed for new biological drugs. The fee for a so-called data-submission drug — a non-new medicine that still requires a safety and efficacy review — will climb to 16 million won ($11,952) from 2.6 million won ($1,937).

The ministry attributed the change to the growing complexity of the clinical, statistical and quality data companies submit with their applications, which has made reviews harder and requires more highly skilled specialist reviewers. Advanced biopharmaceuticals include cell therapies, gene therapies, tissue-engineering products and advanced bio-convergence medicines.

The ministry said the higher fees will provide a basis for hiring more approval and review staff, which it expects to secure the quality of approval and review services for medicines requiring complex scrutiny.

The revisions follow a study on rationalizing the fee system and consultation with industry, including briefings for companies, as a follow-up to the second strategic meeting on rationalizing core regulations, the ministry said.

The two draft revisions — one amending the rules on the safety and support of advanced biopharmaceuticals, the other the regulation on fees for drug approvals — were put out for public comment on Nov. 6. Comments on the fee regulation will be accepted until Nov. 26, and on the advanced biopharmaceutical rules until Dec. 16.