NA LJC to review ‘1+3 bill for generics’ tomorrow

If passed, will likely pass the plenary session in June

Will also review bill for compulsory CSO expenditure report

Bills to penalize illegal purchasers of specialty medicine, putting braille transcription for household medicine will also be reviewed

The National Assembly's Legislation and Judiciary Committee will review the revision of the Pharmaceutical Affairs Act that contains the bill for the ‘1+3 restriction for bioequivalence and clinical test’ of generics and drugs requiring data submission an agenda for review at the NA Legislation and Judiciary Committee’s general meeting that will be held on the 25th.

 

If the revision passes the Legislation and Judiciary Committee, it will be processed and deliberated at the plenary session that is planned on the 29th, and may likely be legislated by June.

 

On the 24th, the vice-chairpersons of the ruling and opposition party of NA’s Legislation and Judiciary Committee are discussing the agendas that will be presented at the plenary session on Monday.

 

One thing to note is that the bills passed by the Health and Welfare Committee on the 16th, including the one to revise the Pharmaceutical Affairs Act, have also been included as agendas at the Legislation and Judiciary Committee meeting.

 

The revised Pharmaceutical Affairs Act passed by the Health and Welfare Committee includes the ‘1+3 restriction for bioequivalence and clinical test’ of generics and drugs requiring data submission, designation of Day of Medicine as a Statutory Anniversary, mandatory preparation and submission of Contract Sales Organization (CSO) expenditure report, penalizing illegal purchasers of specialty drugs, and compulsory marking of safety precautions in Braille and voice codes.

 

The revision also includes the bills to legislate the conditional approval system for Phase III trials, mandatory registration of oversees API manufactories, increasing the number of Central Pharmaceutical Affairs Council members to 300 at most, strengthening regulations for the cancelation of false or unlawfully approved National Lot Release drugs, and the establishment of the Vaccine Safety Technology Support Center.

 

In other words, whether the bill to regulate generics and drugs requiring data submission will be able to pass the final legislative threshold by passing the plenary session of the National Assembly this month will depend on deliberations of the Legislation and Judiciary Committee on the 25th.

 

The Legislation and Judiciary Committee can decide to pass or continue to review the bills passed by the Health and Welfare Committee.

 

If the bill is passed by the Legislation and Judiciary Committee, the final procedure will be carried out at the plenary session on the 29th.

 

When the government finally promulgates the bill, the individual bills will then come into effect according to the by-laws.

 

An official from the Legislation and Judiciary Committee said, “Discussions on the agenda for the plenary session have not yet been completed by the vice-chairpersons.

 

For now, the bill by the Health and Welfare Committee, including the revised Pharmaceutical Affairs Act, is included in the agenda for the plenary session."