Regulations for the Patent Linkage of Drugs Article 16

The new drug not having a new ingredient in Article 48-20 in the Act refers to drugs which are of the preparations having new compositions, new therapeutic compounds or new methods of administration.The provisions under Article 8 through 14 hereof shall be implemented in accordance with Paragraph 1 of Article 48-20 in the Act and shall apply mutatis to the new drugs not having a new ingredient.Except that the apllication for a biosimilar drug permit licence to execute clinical trials is approved before the enforcement date of Chapter 4-1 in the Act by the Central Competent Health Authority , provisions of Chapter 4-1 in the Act with respect to the regulations of the application for a generic drug permit license shall apply mutatis to the apllication for a biosimilar drug permit licence.The term “biosimilar drug” as used in the preceding Paragraph refers to preparations that are similar to its reference biological new drug, have been made of biological sources and approved by the Central Competent Health Authority to manufacture and import.