The industry is paying attention to the review of generics

Next week, the Legislative Subcommittee confirms the evaluation, and the legalization of conditional permits is also made

Including bills for vitalization of generic substitution and mandatory CSO expenditure reports

Following the generic joint bioequivalence test '1+3 Restriction Act', the Drugs for Data-Based Re-evaluation (IMD) clinical data '1+3 Restriction Act' will be submitted to the National Assembly's Health and Welfare committee (Legislative Subcommittee) to be held next week.

 

The two bills initiated by Democratic Party of Korea Rep.

 

Seo Young-suk and People Power Party Rep.

 

Seo Jeong-sook, respectively, have strengthened their influence on the pharmaceutical industry if passed as a merger review was decided.

 

A bill to upgrade the CMA (Conditional Marketing Authorization) system for clinical trials operated by the MFDS to the pharmaceutical affairs law has also been newly added as an agenda for review of the legislation.

 

On the 21st, Kim Min-seok, chairman of the Welfare Committee, and the secretaries of the ruling and opposition parties discussed the agenda of the subcommittee on the bill.

 

Earlier, after the plenary meeting on the 26th, the Welfare Committee confirmed the schedule of the 2nd Subcommittee on the 27th and the 1st Subcommittee on the 28th.

 

In the Legislative Subcommittee, which will be held this time, a law under the jurisdiction of the MFDS, which was not reviewed in February, will be first reviewed.

 

In particular, the pharmaceutical affairs law, which has a great influence on the pharmaceutical industry and pharmacy, was included.

 

The most representative bill is the combined review of the bioequivalence test 1+3 regulatory bill (by Seo Young Seok), which aims to prevent the overrun of generic drugs, and the law limiting the number of joint use of IMD clinical trial data to four pharmaceutical companies (by Seo Jeong-sook).

 

The generic joint bioequivalence test 1+3 regulatory bill was put forward in February, but it did not have an opportunity for review.

 

IMD's 1+3 regulation bill, which was proposed afterwards, was newly added as an agenda, and the Welfare Committee decided to review the two bills together.

 

If the bill passes the deliberation of the welfare committee, the impact on the pharmaceutical industry and pharmacies will be greatly increased.

 

In particular, there are opinions that generic and IMD licensing regulations should be strengthened in preparation for the past as illegal cases of voluntarily manufacturing pharmaceuticals in violation of the GMP regulations of the Pharmaceutical Affairs Act are discovered one after another.

 

The merged review of the 1+3 bills for IMD Next week, the Legislative Subcommittee confirms the evaluation.

 

Including bills for vitalization of generic substitution and mandatory CSO expenditure reports Following the generic joint bioequivalence test '1+3 Restriction Act', the Drugs for Data-Based Re-evaluation (IMD) clinical data '1+3 Restriction Act' will be submitted to the National Assembly's health welfare committee (Legislative Subcommittee) to be held next week.

 

In particular, the two bills initiated by Democratic Party of Korea Rep.

 

Seo Young-suk and People Power Party Rep.

 

Seo Jeong-suk, respectively, have strengthened their influence on the pharmaceutical industry if passed as a merger review was decided.

 

A bill to upgrade the CMA (Conditional Marketing Authorization) system for clinical trials operated by the MFDS to the pharmaceutical affairs law has also been newly added as an agenda for review of the legislation.

 

On the 21st, Kim Min-seok, chairman of the Welfare Committee, and the secretaries of the ruling and opposition parties discussed the agenda of the subcommittee on the bill.

 

Earlier, after the plenary meeting on the 26th, the Welfare Committee confirmed the schedule of the 2nd Subcommittee on the 27th and the 1st Subcommittee on the 28th.

 

In the Legislative Subcommittee, which will be held this time, a law under the jurisdiction of the MFDS, which was not reviewed in February, will be first reviewed.

 

In particular, the pharmaceutical affairs law, which has a great influence on the pharmaceutical industry and pharmacy, was included.

 

The most representative bill is the combined review of the bioequivalence test 1+3 regulatory bill (by Seo Young Seok), which aims to prevent the overrun of generic drugs, and the law limiting the number of joint use of IMD clinical trial data to four pharmaceutical companies (by Seo Jeong-sook).

 

The generic joint bioequivalence test 1+3 regulatory bill was put forward in February, but it did not have an opportunity for review.

 

IMD's 1+3 regulation bill, which was proposed afterwards, was newly added as an agenda, and the Welfare Committee decided to review the two bills together.

 

If the bill passes the deliberation of the welfare committee, the impact on the pharmaceutical industry and pharmacies will be greatly increased.

 

There are opinions that generic and IMD licensing regulations should be strengthened in preparation for the past as illegal cases of voluntarily manufacturing pharmaceuticals in violation of the GMP regulations of the Pharmaceutical Affairs Act are discovered one after another.

 

Rep.

 

Young-Seok Seo, who initiated the generic regulation bill, argued that it would be possible to prevent the recurrence of the BINEX incident by regulating the 1+3 joint bioequivalence test at the time of the BINEX incident.

 

Rep.

 

Seo Jeong-suk has also initiated a bill to regulate the IMD.

 

The MFDS’ phase 3 clinical conditional expedited approval bill is also being reviewed by the Act Subcommittee.

 

The bill was initiated by Democratic Party Rep.

 

Nam In-soon, along with Rep.

 

Jong-heon Paik, the Power of the People, and the merger was decided.

 

The main goal is to upgrade the system for marketing approval for drugs for treatment of severe intractable diseases such as rare cancers to the pharmaceutical affairs law from the existing notification, subject to the submission of the results of phase 3 clinical trials.

 

It strengthens the management and operation of conditional permits, and contains provisions that clearly stipulate the subject of conditional permits, conditions for granting, and reasons for cancellation of permits.

 

An amendment to the pharmaceutical affairs law (by Seo Yeong Suk) was also on the agenda, in which the name of generic substitution was changed to the same ingredient preparation, and the doctor who prescribed for follow-up notification at the pharmacy added and expanded it to the HIRA to activate the generic substitution.

 

Pharmacy notified the physician who prescribed it afterwards, but the amendment to the pharmaceutical affairs law (by Seo Young Seok) was also on the agenda to activate the alternative preparation to be added or expanded to the HIRA.

 

In addition to pharmaceutical companies that manufacture and sell drugs, bills that require physicians and pharmacists to report on expenditures for CSOs (pharmaceutical sales agencies) entrusted with sales promotion tasks (by Seo Young-seok, Jung Chun-suk, and Go Young-in) are also under review.

 

Drug day is designated as a national anniversary (by In Jae-geun), strengthened management of raw material drug and national lot release (by Kim Sang-hee), increased the penalty for drugs for false and illegal national lot releases (by Kang Byung won, and mandatory braille markings and voice codes for medicines (by Hye-young Choi and Ye-ji Kim), punishment for illegal purchasers of Rx drug's (by Seo Jeong-suk and Lee Sang-heon), and obligatory guidance for pharmacists to take medicine for drug waste (by Yeon-sook Choi) were also proposed for this bill review agenda.