Data Exclusivity Bill for IMDs may soon be legislated

For incrementally modified drugs

Will be legislated in the 9th plenary session if it passes the legislative committee... expected to encourage new drug development

Bill includes abolishment of the re-review system and unification of RMP regulations

A bill to amend the Pharmaceutica Affairs Act, which grants a 6-year data exclusivity for incrementally modified new drugs that have obtained domestic marketing authorization, was reviewed during the plenary session of the Legislation and Judiciary Committee that was held on the afternoon of the 8th.

 

If approved by the committee, the bill will be passed during the plenary session tomorrow (Sept.

 

9) and be legislated.

 

The bill also suggest abolishing the drug re-review system and replacing it with a risk management plan (RMP).

 

In particular, there is great interest in the new provision in the bill that recognizes exclusive rights to new and incrementally modified drugs and protects clinical trial data submitted at the time of drug approval.

 

Specifically, the bill provides 10 years of protection from the date of approval for orphan drugs.

 

This can be extended by an additional year if a pediatric indication is added.

 

New drugs are granted 6 years of data exclusivity from the date of approval, and drugs that submit new clinical trial data, such as cto hanging the type of active ingredient to improve the safety, efficacy, and utility of already approved drugs, are granted 6 years of exclusivity from the date of approval.

 

Based on this provision, IMDs can be granted a 6-year data protection period based on the provision.

 

In addition, drugs designated by the Prime Minister's Decree that require submission of new clinical trial data are granted a 4-year data protection period.

 

The existing reexamination system provides 10 years of data protection for orphan drugs, 6 years for new drugs and drugs with new active ingredients, formulation ratios, and routes of administration, and 4 years for new drugs with new efficacy and effect.

 

If the bill passes the National Assembly, it is expected the data exclusivity of IMDs developed many domestic pharmaceutical companies will be recognized, Teh bill provides exclusivity when developing improved versions of their existing drugs, especially in terms of fficacy or utilit, with raises possibility of the development of a cash cow during new drug development.

 

The bill is likely to pass the National Assembly because the Ministry of Food and Drug Safety (MFDS) is in favor of it and has been involved in its legislation, and it is in line with the government's policy of creating domestic blockbuster drugs.

 

The MFDS said, "We agree with the purpose of the amendment to reduce the burden of data submissions to the pharmaceutical industry by integrating the drug reexamination system and risk management system, and to enhance Korea R&D capabilities in the pharmaceutical industry by establishing a legal basis for the drug data protection system."