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.
The related regulation has been amended so that me-too registration applicants are required to submit full registration data as the original submitter.
Rural Development Administration Notification 2009-1, Jan 12, 2009
Local and imported formulations
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.
Re-validation of products
There are plans to allow re-validation after considering the characteristics and packing materials of each product.
Re-formulation of imported agrochemical products
In case of imported products with newly developed substances, it may be difficult to supply the active component (unregistered original material).
It is also difficult to prove that the re-formulated product is identical to the original product.
Minimum facilities (i.e. laboratory) for distribution and quality control of registered products are still required although other requirements of formulation facilities will be eased after consideration.
