Korean government authority protects all the registration studies which were conducted with the formulated product very well, but in case of active ingredients, the authority gives the me-too registration applicants the data exemption to a great extent for generic me-too active ingredient registration, which can give the very easy market access to the me-too registration applicants with very low cost, even though 15-year data protection period is specified in Korean Pesticide Management Act. Korean government very well protects all the registration studies conducted with the formulated products.
However in the case of active ingredients, the Korean government gives data exemption to the me-too registration applicants with regards to the generic me-too active ingredient registrations.
This results in providing an extremely favorable market access to the me-too registration applicants with a very low cost despite the 15 year data protection period specified in Korean Pesticide Management Act.
So, the current Korean system is very contradicted to USA, EU and Japanese data protection system which only permit me-too registration of generic active ingredient when me-too registration applicant submit full data just like original submitter unless the original data submitter gives written permission for using its data. Therefore, the data protection for active ingredient is practically not implemented in Korea.
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