The method of writing for HBP combination is improved

Including dyslipidemia complex

It is prepared based on the evaluation of the composite product by breaking away from the existing individual ingredients listing method

The efficacy and effect are described in consideration of the purpose of administration, clinical results, and primary and secondary therapy

The method of writing permission for HBP and dyslipidemia combinations is improved more efficiently.

 

Previously, information on individual ingredients was simply listed, but in the future, it will be prepared based on a comprehensive evaluation of combinations.

 

According to the pharmaceutical industry on the 6th, the MFDS prepared a plan to improve the method of writing permission for high blood pressure and dyslipidemia combination drugs and guided them through pharmaceutical organizations.

 

According to the improvement plan, the efficacy of the high blood pressure and dyslipidemia combination will be described in consideration of the purpose of administration, clinical trial results, and primary and secondary therapy.

 

In particular, precautions related to the treatment of individual ingredients for dyslipidemia should not be described.

 

However, in the case of a composite containing Ezetimibe, the matters related to diet, administered drugs, and lipid tests described in the "effect" can be stated in the "Precautions for Use." The precautions for use include prohibition of administration of each main ingredient, careful administration, and general caution related to administration as a complex agent.

 

As for the adverse reaction, the contents of the clinical trial conducted as a composite agent may be first described, and then the adverse reaction may be additionally described as a single agent.

 

However, adverse reactions of unlicensed ingredients can be omitted.

 

For example, in the case of the fourth composite, the adverse reactions of the second to third composite agents should not be described.

 

As the existing permission for high blood pressure and dyslipidemia complex drugs lists information on individual components, it is difficult for the general public to recognize the product characteristics of the combination drugs, and only the attached documents are prolonged.

 

In this improvement plan, the MFDS said, "The permission for complex drugs should provide information so that experts and patients can use the drug safely and effectively." The MFDS explained, "It should be mainly prepared based on information obtained from combination or combined administration, and information obtained when individual ingredients are administered alone can be additionally presented if appropriate." An official from the MFDS said, "There was an opinion that it was difficult to read the existing description method because it lists individual ingredients." The MFDS distributed a revision to the "Guidelines for Clinical Trial of Combination Drugs" along with this improvement plan to guide efficacy, effectiveness, and approval of primary therapy.

 

According to the guidelines, if an unlicensed single agent is developed as a combination agent, in principle, it is possible to obtain permission only for the efficacy of the combination drug through clinical trials (therapeutic confirmation clinical trials, etc.).

 

In order to be approved as a primary therapy, the feasibility of development as a primary therapy must first be proven in consideration of the mechanism of action of individual main components of the complex and clinically recommended treatments.

 

In particular, it is possible when a therapeutic confirmation clinical trial is conducted on patients who need to administer complex drugs from the beginning to reach the target treatment effect, and safety and effectiveness are proven.