MFDS clarifies support for advanced biopharmaceuticals

Clarifies standards on fee reductions and support measures for advanced biopharmaceuticals

MFDS announces revision of “Regulations on the Safety and Support of Regenerative Medicine and Advanced Biological Products”

With the Ministry of Food and Drug Safety raising the approval and review fees for advanced biopharmaceuticals by up to KRW 410 million from January 1 this year, it has clarified the criteria for those eligible for fee reductions.

 

In addition, detailed administrative disposition standards have been set for cases where human cell managers and cell processing facilities commit two or more violations.

 

According to industry sources on the 1st, the MFDS recently re-announced its partial amendment to the Regulations on the Safety and Support of Regenerative Medicine and Advanced Biological Products and is collecting opinions.

 

The revision includes the following provisions: ▲Integration of forms related to new drug fees (Appendix 4); ▲Clarification of fees for new drugs eligible for expedited processing; ▲Addition of supplementary provisions (application examples and transitional measures) to clarify the application of fee regulations; ▲Clarification of the wording of administrative disposition standards (Appendix 2).

 

Specifically, the provision that previously stated that small and medium-sized enterprises would receive a 50% reduction in approval and review fees has been revised to require that the reduction be granted only if certain conditions are met.

 

For fee reductions on new drug approvals, among advanced biopharmaceuticals designated for expedited review, the applicant must meet at least one of following conditions: ▲Manufacturers or entities that have filed a commissioned manufacturing and sales report in accordance with Article 23(3) of the Act, who have applied for product approval under Article 23(2) and (3) of the Act, customized review under Article 37(1), or conditional product approval under Article 38(1) of the Act.

 

▲Importer who has applied for an import license under Article 27(1) of the Act, customized review under Article 37(1), or conditional product approval under Article 38(1) of the Act For advanced biopharmaceuticals not designated for expedited review, fee reductions apply only when an applicant applies for marketing authorization under Article 23(2) and (3) of the Act.

 

If the conditions for reduction are met, the fees for the approval and review of advanced biopharmaceuticals are set as follows: KRW 205 million for advanced biopharmaceuticals classified as new drugs requiring safety and efficacy reviews, KRW 123 million for those requiring reviews of manufacturing and quality control standards and test methods, and KRW 41 million for those requiring an evaluation of the implementation status of manufacturing and quality control standards.

 

Additionally, the administrative disposition standards for cases involving two or more violations have been clarified as follows: “In cases where two or more violations have occurred, the most severe administrative penalty standard shall apply.

 

However, if the administrative penalty standards correspond to the same business suspension, the most severe administrative penalty standard shall be applied, with half of each remaining administrative penalty standard added, provided that the maximum period does not exceed one year.” Meanwhile, in January, the MFDS raised the fees for new drug approval and preliminary review by about 50 times to KRW 410 million to strengthen the speed and expertise of new drug approval reviews.

 

The revised fees apply to new drugs (including advanced biopharmaceuticals) and drugs that have been granted marketing authorization as orphan drugs and subsequently apply for conversion to new drug status (change approval).

 

The review period is expected to be reduced from an average of 420 days to 295 days.