- Policy
- “Riavax problem even noticeable for incompetent officer"
- by Lee, Jeong-Hwan Oct 14, 2020 06:24am
- Witnesses at National Assembly annual audit reproached Riavax, the immunotherapeutic peptide for pancreatic cancer treatment revoked from marketing approval, has apparently submitted review materials that every researcher at Ministry of Food and Drug Safety (MFDS) would notice how they were poorly prepared. Regardless of the failure in g
- Policy
- What is the result of 759 illegal rebate-related drugs?
- by Lee, Jeong-Hwan Oct 14, 2020 06:23am
- In the last five years, 759 drugs were counted as having received administrative disposition for illegal rebates. Dong-A ST ranked first in the number of rebate disposals with 267 items, while CJ Healthcare ranked second with 114 items and Hanall Biopharma ranked third with 74 items. Among them, only 96 items were suspended from application of m
- Policy
- Orphan drugs introduced in Korea are 'increasing'
- by Lee, Tak-Sun Oct 14, 2020 06:22am
- As the orphan drug market has recently emerged as Blue Ocean, the introduction of Orphan Drugs by global pharmaceutical companies is increasing in Korea. In particular, as the MFDS has given a PMS of up to 11 years to Orphan Drugs through amendment of regulations, the market monopoly is expected to be prolonged. According to the MFDS o
- Policy
- Copayment unchanged for using reimbursed Dupixent
- by Lee, Hye-Kyung Oct 14, 2020 06:22am
- When processing atopic dermatitis patients visiting tertiary hospitals, the healthcare institutes should now be aware that the 100-percent outpatient copayment rate does not apply to the severe case patients. On Oct. 7, the Ministry of Health and Welfare (MOHW) and Health Insurance Review and Assessment Service (HIRA) provided informatio
- Policy
- 'Adding CSO' to the target of rebate penalty
- by Lee, Jeong-Hwan Oct 13, 2020 06:05am
- A revision of the law is being promoted so that not only pharmaceutical companies that gave rebates to doctors and pharmacists, but also the Contract Sales Organization (CSO) that they delivered on their behalf, can be directly punished for violating the Pharmaceutical Affairs Law. It is to clarify the grounds for administrative dispositio
- Policy
- HIRA finally revises PE guideline after 9 years
- by Lee, Hye-Kyung Oct 13, 2020 06:05am
- Finally, the pharmacoeconomic evaluation (PE) guideline is to be revised after nine years. South Korea’s Health Insurance Review and Assessment Service (HIRA) is accepting public opinion until Dec. 6 for the unveiled draft of revised PE guideline that reflects most of the suggestions made in the 2019 research on PE guideline revision (P
- Policy
- Many companies apply for a patent challenge for Otezla
- by Lee, Tak-Sun Oct 13, 2020 06:05am
- Korean pharmaceutical companies' patent challenges are continuing on new psoriasis treatments that are not released in Korea due to the failure to apply insurance benefits. Otezla (Apremilast), which was approved in 2017 as a treatment for psoriasis and psoriatic arthritis in Korea, has recently received a patent challenge from domestic co
- Policy
- Drugs exempt from economic evaluation are applied to RSA
- by Kim, Jung-Ju Oct 13, 2020 06:05am
- From today (8th), generic drugs under risk-sharing agreements (RSA), drugs exempt from economic evaluation, and drugs released with early permission under the condition of Phase III are also covered by RSA between insurers and pharmaceutical companies. A new legal basis for adjusting the limit upper price will be established in the case o
- Policy
- Pharmaceutical reimbursement standards should be updated
- by Lee, Hye-Kyung Oct 12, 2020 06:13am
- It has been argued that the government should be active from screening for osteoporosis to creating a continuous treatment environment and establishing an integrated treatment system for preventing fractures in stages. On the 7th, Bong-min Jeon, a member of People Power Party (Health and Welfare Committe, Suyeong-gu, Busan), published a na
- Policy
- 'Abortion' within 14 weeks of pregnancy is allowed
- by Lee, Tak-Sun Oct 12, 2020 06:13am
- As the government allowed abortions in early pregnancy in accordance with the Constitutional Court's ruling against the constitution of abortion, it also decided to permit spontaneous abortion inducing medicines. Accordingly, it is noteworthy whether 'Mifegyne', which is widely used overseas, will be officially introduced in Korea. The gov
