Generics reform in Korea Posted 31/07/2020

The Korean Ministry of Food and Drug Safety (MFDS) has taken action to improve the quality of generic drug products and ensure an efficient and competitive generics market.

In July 2020, the Korean MFDS released new guidelines to ensure improved manufacturing and quality control of generics made through consignment contracts. In these guidelines, the duties and responsibilities of consignors and consignees are laid out and well defined. The consignors are defined as manufacturers of raw materials, additives, in-process material and finished drugs. In contrast, consignees do all or part of the manufacturing on behalf of the consignor. It is hoped that this will help ensure high standards of good manufacturing practices and thorough quality control.

Additionally, the Korean MFDS announced that it will start providing information about generic drugs to make it easier for the public to identify differences between generic drug products. This is in response to the rapid growth of the number of generics on the Korean market that have different names but the same ingredients. This has led to rebate practices becoming prevalent. To tackle the inefficiencies of the market and strengthen the international competitiveness of generics, the government formed a public–private consultative body. This has prompted the recent announcement and the decision to publicize the name of the pharmaceutical company which performs bioequivalence tests on generic drugs.

By checking the ministry’s website, it will soon be possible to easily identify which generics are made in the same manufacturing facilities using the same production processes on the basis of the bioequivalence test results. It is hoped that this increased transparency will prevent companies flooding the market with generic products.

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