Items Issues Recommendations
1)
Data protection

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.


It is recommended to implement 10-year actual data protection system for active ingredient in harmonization with USA, EU by not granting me-too registration of generic active ingredient unless me-too registration applicants submit full registration data just like original submitter or the original data submitter gives written permission for data use, in order to promote the development of innovative, safer molecule for user, consumer and environment.
2)
Local and imported formulations

Korean system provides a very different treatment in (between) local formulations and imported formulations of agrochemicals, as (constituting then a real) barrier in doing business in Korea. ¡°Local formulations¡± are products formulated in Korea by importing the technical materials of agrochemicals, while ¡°imported formulations¡± are products imported after being formulated outside of Korea. The discriminated (-ing) barriers to the imported formulations of agrochemicals are as follows:

- Re-validation or re-formulation of products after shelf-life: when product shelf-life is over, re-validations or re-formulations for imported formulations are not allowed in Korea but it needs to be shipped back to the country where it has been formulated. There is no way to re-validate or re-formulate the expired products of imported formulations in Korea in any case. Even if the expired products are on-spec in terms of a.i. content and physico-chemical properties, they are considered as off-spec because the shelf-life date is over.
- Registration onwership of local formulations: the registration of local formulations can not be owned by one who does not own specific formulation facility. In other words, a company is required to invest in formulation facilities in Korea if he (it) wants to own product registrations of local formulations. This is a big burden for new comers who want to own it as intellectual property.

The regulations in terms of re-validation or re-formulation of products after shelf life should follow global (FAO) standards so that they can be re-validated by the manufacturer without shipping them back physically to the manufacturer.
Registration ownership should be allowed without restricting by any facilities.