Cases of Vivozon & Binex need ‘1+3 Regulation Act’

Proposed by Rep. Young-Seok Seo, the passing of the generic regulation bill is a pre-determined fact

Proposed by Seo Jeong-suk, IMD's regulatory bill is also needed

There is a consensus on the problems of drugs distributed in Korea

Following Binex, Vivozon illegally manufactured medicines in violation of the Pharmaceutical Affairs Act.

 

As a result, the '1+3 Regulation Act' legislation that directly limits the number of drug became valid.

 

The reason was the domestic licensing system and regulatory environment in which too many generics could obtain marketing licenses.

 

Vivozon's incident made ‘1+3 Regulation Act’ even more necessary.

 

According to the National Assembly and pharmaceutical industry officials on the 12th, Binex and Vivozon incidents further necessitated a legislative 1+3 Regulation Act for generics and data submission drugs.

 

1+3 Regulation Act was proposed by Rep.

 

Yeong-Seok Seo (Democratic Party of Korea) and Rep.

 

Jeong-sook Seo (People Power Party)'s ‘Drugs for data-based re-evaluation 1+3 restriction' amendment to the Pharmaceutical Affairs Act is pending in the National Assembly.

 

Drugs for data-based re-evaluation 1+3 restrictions were opposed by some pharmaceutical companies and the MFDS' opinion was cautious, but the generic 1+3 Regulation Act was approved by many pharmaceutical companies and the MFDS.

 

It is expected to pass if only the opportunity for examination is obtained at the temporary National Assembly in March.

 

If the generic 1+3 Regulation Act is passed, the data submission drug (IMD) 1+3 regulation, which will be discussed, will be also valid.

 

Binex and Vivozon incidents are accelerating the legislation of Drugs for data-based re-evaluation 1+3 restriction.

 

Rep.

 

Seo Young-seok appealed to the necessity of expediting the passage of the 1+3 Regulation Act immediately after Binex crisis.

 

An MA (Market Access) manager at a top domestic pharmaceutical company said, "In fact, many pharmaceutical companies and the KPBMA have been consensus for a long time in the joint bioequivalence 1+3 regulation to resolve the generic mess." "Only some small pharmaceutical companies that are difficult to test for their own bioequivalence were opposed," he said.

 

"But, as the government's regulatory policy on generic drug prices, generics without bioequivalence testing will no longer be sold on the market." He said, "The passing of the generic 1+3 Regulation Act (by Seo Young Seok) due to the Binex and Vivozon incidents is a pre-determined fact.

 

The ruling party, the opposition party, and the government have the same opinions, so it is highly likely to pass." He added, “The quality manipulation situation has further increased the validity of the regulatory bill.

 

It is pointed out that too many drugs have been released in the market, and the regulatory authorities are also not able to manage quality.” An official from the National Assembly's Health and Welfare Committee said, "The generic 1+3 Regulation Act was a bill that had a great influence on the domestic pharmaceutical industry, front-line medical institutions, and pharmacies, but it was a bill that was not well understood by the public." "If public opinion raises a strong issue in the case of low-quality drug distribution or quality-manipulated pharmaceutical companies, the National Assembly will inevitably have a legislative law reflecting public opinion." He said, "It is not because of the public opinion that the examination of the bill changes, but the speed of examination and promotion of the bill will be faster.

 

In addition, the interest of the National Assembly members will also increase.

 

The results of the internal investigation by the MFDS will also affect the validity of the 1+3 bill."