MFDS' drug data protection to be implemented next year

Phase 3 clinical trial documents demonstrating improvements in dosage and administration for already approved drugs

Starting next year, innovative new drugs (IND) or those developed with new indications will have their approval data protected for up to six years, drawing attention to whether this will encourage domestic pharmaceutical companies to conduct more clinical trials.

 

The Ministry of Food and Drug Safety (MFDS) will implement the Pharmaceutical Data Protection System starting February 21 to enhance the current post-marketing surveillance (PMS) system.

 

The new data protection system has been established as a regulatory measure for integrating the systems for post-marketing safety, including the re-examination system and risk management plan.

 

Under this system, clinical trial data submitted for marketing authorization of a drug will be protected to ensure it cannot be used by any entity other than the original submitter to obtain approval for a similar product.

 

The Pharmaceutical Data Protection System, which is to be added to the Pharmaceutical Affairs Act on February 21.

 

Data Protection Period: 1.

 

Orphan Drug: 10 years from the date of marketing authorization (Additional 1 year if adding pediatric indication), 2.

 

New Drug: 6 years from the date of marketing authorization, 3.

 

Drug requiring submission of new clinical trial data due to a material change to a drug already approved, as prescribed by the Prime Minister

The amendment specifies that data protection will apply to drugs with significant changes to their active ingredients or other essential properties (called incrementally modified drugs) to improve safety·efficacy·utility, and other necessary data protection cases.

 

According to Article 31-6(1)(3) of the Pharmaceutical Affairs Act, drugs with significant changes to their active ingredients or other essential elements are granted a data protection period of six years.

 

Specifically, ▲Clinical trial data submitted at the time of approval to demonstrate the efficacy of combination therapies for prescription drugs with a different composition or ratio of active ingredients compared to already approved drugs ▲Clinical trial data submitted at the time of approval for prescription drugs with the same active ingredients as already approved drugs but with a different administration route.

 

For example, clinical trial data for drugs where the route of administration is changed from continuous intravenous infusion, requiring more than 24 hours after hospitalization, to subcutaneous injection to improve patient convenience will be protected for six years.

 

Clinical trial data for combination drugs with different active ingredients compared to already approved drugs will also be protected for six years.

 

Meanwhile, combination drugs that are developed using two active ingredients, both already approved for combination therapy, do not qualify for data protection Under Article 31-6(1)(4) of the Pharmaceutical Affairs Act, a data protection period of four years is granted for 'Other cases that require data protection.' In detail, ▲Clinical trial data submitted to demonstrate clearly different therapeutic effects or to add distinctly different indications ▲Clinical trial data submitted at the time of approval for studies conducted in children under 12 years old ▲Drugs deemed necessary for data protection by the MFDS (such as new isomers, salts, formulations, or dosage strengths of already approved drugs to improve usage and dosage.

 

These cases will be reviewed individually based on newly submitted clinical trial data) ▲Drugs for which expert consultations, such as those conducted by the Central Pharmaceutical Affairs Advisory Committee (CPAC), have determined that data protection is required.

 

Phase 3 clinical trial data can also be included for pharmaceuticals deemed necessary for data protection by the MFDS.

 

Pharmaceuticals eligible for data protection criteria indicate that each case will be reviewed individually for clinical trial data (Phase 3) submitted to demonstrate improvements in dosage and administration for already approved drugs and data submitted for adding 'other indications or effects' that are not distinctly different from existing uses of the same active ingredients and administration routes.

 

Technically, clinical trial data eligible for protection must consist of new data required for approval.

 

Data submitted for the approval of drugs that are identical to existing ones (regarding active ingredients, specifications, dosages, forms, indications, and routes of administration) do not qualify for protection.