MFDS to review reference drug application every 2 months

Will accept applications and notify reference drug changes every 2 months…will have a positive effect on the development of generic drugs

Domestic pharma industry expects the change to bring ease to generic drug development. in korea..expects a practical operation method

The change in the procedure for selecting reference drugs for pharmaceutical equivalence tests is being well received by the domestic pharmaceutical industry.

 

The Ministry of Food and Drug Safety recently announced a revision to the 'Guideline for Selecting Reference drugs for Pharmaceutical Equivalence Tests' and is seeking opinions on the change, deciding to proceed with the application and announcement of reference drugs every 2 months instead of every quarter.

 

With the revision of the guideline, reference drug applications will be accepted six times a year (September 16-November 15, November 16-January 15, January 16-March 15, March 16-May 15, May 16-July 15, and July 16-September 15) and reference drugs will be announced in February, April, June, August, October, and December, respectively.

 

The shortened period for selecting reference drugs is expected to help facilitate the smooth conduct of pharmaceutical equivalence tests and the development of generic drugs.

 

In this regard, an official from pharmaceutical company A said, “In the past, the delay in designating a reference drug has often delayed the development schedule.

 

If the designation of a reference drug is regularly conducted two months rather than every quarter, this will well speed up development.” Another official from pharmaceutical company B also said that shortening the schedule for selecting and announcing reference drugs will basically revitalize generic drug development, which is why domestic companies cannot be opposed to it.

 

However, the official added that in practice, shortening the reference drug designation by 2-3 months cannot significantly reduce the drug development period.

 

He emphasized, “We also expect improvements in operational methods, starting with the revision of the reference drug selection and announcement procedures.

 

While designating reference drugs is important, it is also necessary to make reasonable judgments on whether to maintain the reference drug status for drugs that are not imported or produced domestically, despite being designated as reference drugs.” When reviewing applications for the designation (or change) of reference drugs, the government selects products from the same active ingredient type and content, formulation, and route of administration among approved (or reported) products, but those of a higher priority.

 

The priority order for selecting reference drugs is as follows: ▲New drugs as defined in Article 2 of the Pharmaceutical Affairs Act that have received approval as prescription drugs for manufactured (imported) products; ▲Products by the original developer (if there are multiple products, the product with the earliest approval date); ▲Products that are subject to data submission under Article 2, Paragraph 8 of the Regulations on the Approval, Notification, and Review of Drug Products, and are the first products approved in Korea; ▲Products that meet Item 1 or Item 2 and have undergone bioequivalence testing ▲Domestically first-approved products (if the product has been canceled or withdrawn, it refers to products with the same active ingredient type and administration route as the domestically first-approved product, following the order below) etc.

 

A representative from Company B stated, “If there is no reference drug, the reference drug must be purchased from overseas to conduct equivalence tests, but the company whose drug was designated as the reference drug does not disclose all details, such as the quantity of the active pharmaceutical ingredient.

 

While the selection and announcement of reference drugs are important, the system must be improved to ensure proper operation, including measures to revoke reference drug status.”