Labeling will be promoted on product packaging

About pharmaceutical companies that conducted bioequivalence test

The MFDS, draws up the final plan through this month. Preparation of quality evaluation indicators

In the future, it is expected that pharmaceutical companies carrying out bioequivalence tests will be separately labeled on generic drug packaging.

 

In addition, policy initiatives are being undertaken to strengthen the global competitiveness of generic drugs, such as finding ways to disclose generic companies on a manufactory basis.

 

The MFDS announced on the 1st that it is planning to draw the final plan through the public-private consultative body to strengthen the international competitiveness of generic drugs by this month.

 

The public-private consultative body, which strengthens the international competitiveness of generic drugs, has been in operation since April, consisting of about 50 people from the pharmaceutical industry, academia, medical experts, patients, and consumer groups.

 

The tasks for which the public-private consultative body came up with the final plan are: ▲ Conduct bioequivalence test, strengthen drug labeling and information disclosure ▲ Develop bioequivalence test evaluation indicators and disclose evaluation results ▲ Establish a generic drug database for each ingredient.

 

First, among generic drugs, the number of bundled products that are entrusted and manufactured by companies that have not already conducted a bioequivalence test directly is increasing.

 

Therefore, it is necessary to promote a method of labeling the product, such as the name of the pharmaceutical company that actually conducted the bioequivalence test.

 

In particular, the MFDS explained that it is also considering ways to bundle generic drugs with the same bioequivalence test as a factory standard, and to disclose the information through the MFDS website and prescription preparation system.

 

It means that bioequivalence tests are conducted on generic drugs, and products that are manufactured directly and products that have been granted product approval through consignment manufacturing are released together.

 

The MFDS will also develop bioequivalence quality assessment indicators and disclose the evaluation results.

 

It is a plan to increase the quality level and reliability of generic drugs by preparing quality evaluation indicators and transparently disclosing the evaluation results so that they can evaluate the quality level of generic drugs.

 

The MFDS said that the analysis of the effect of the actual use stage after marketing, the MFDS in the bioequivalence test results indicates the ratio (The closer to 1 means the same) of the generic drug (test drug) to the original drug (control drug), the frequency of side effects after the generic drug is marketed may be an example for the quality evaluation index.

 

In addition, the generic drug, which is manufactured by entrusting the entire process, will also clarify the responsible relationship between trustees, such as entrusting quality control obligations to consigned companies and strictly managing quality management of consigned companies.

 

In addition, the establishment of a generic drug database for each ingredient will be promoted.

 

In response, the MFDS will explain the current status of generics by ingredient in English so that overseas buyers and distributors can identify them to support the global advancement of generic drugs, and will also provide them to international organizations such as the World Health Organization (WHO).

 

An official from the MFDS said, "We plan to prepare a plan to improve the specific system so that the contents under the agreement can be carried out normally in the public-private consultative body, and to prepare and announce a detailed action plan for the improvement method by the end of June."