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- 2025-12-25 13:57:35
- Policy
- The redemption of α-GPC benefits extended until March 15
- by Lee, Hye-Kyung Feb 15, 2021 06:17am
- The contract for reimbursement of benefits related to α-GPC, a brain function improvement drug, was extended until March 15th. The MOHW ordered The NHIS to extend the deadline for negotiations on the Choline alfoscerate formulation on the 10th. February 10, which ordered an extension of the negotiation period, marks the end of the first negotiations for the MOHW to end negotiations and contracts for 129 pharmaceutical companies and 227 items of α-GPC(Choline alfoscerate). On December 14, 2020, the MOHW ordered the termination of the contract for reimbursement of benefits for Choline alfoscerate by February 10 in accordance with the Rules on the Standards of National Health Insurance Medical Benefits. A total of 56 pharmaceutical companies, including 28 pharmaceutical companies such as Chong Kun Dang and 28 pharmaceutical companies including Daewoong, among the 129 pharmaceutical companies to be negotiated, have suspended executions and administrative litigation regarding the cancellation of negotiation orders and notifications against the Minister of Health and Welfare and the Chairman of the NHIS. During the negotiation period, the Seoul Administrative Court dismissed pharmaceutical companies' applications for suspension of execution on January 27 and 29, but disapproved with the results as pharmaceutical companies filed appeals. Dissatisfaction with the results of the court had an impact on the negotiation process. This is because there was no pharmaceutical company that agreed to the NHIS' redemption contract until February 10, when the negotiations ended. The MOHW decided to extend the redemption negotiation order for one month. According to Article 2-2, Paragraph 2 of the Drug Price Negotiation Guidelines, in spite of '1 (60 days from the day after the day after the Minister of Welfare ordered the negotiation), each subparagraph (if the Minister of Welfare ordered the negotiation by setting a separate negotiation period), If the Minister of Health and Welfare has ordered a temporary suspension of negotiations or postponement of the negotiation deadline pursuant to Article 11, Paragraph 2 of the Standards for Medical Benefits), it shall be up to a period or time limit separately determined in accordance with each subparagraph. The negotiation period was specified. In the case of Choline alfoscerate, when the NHIS Chairman requests the Minister of Health and Welfare for reasons such as delay in accordance with Article 11-2, Paragraph 7 of the Rules, the deadline may be delayed or temporarily suspended within 60 days. The NHIS will conduct negotiations again for each pharmaceutical company during the extended negotiation period for an additional month. In the event of a clinical trial failure, pharmaceutical companies must agree to return or break down the entire health insurance prescription amount from the date of submission of the clinical protocol to the MFDS to the date of deletion to the NHIS. The reimbursement for the current health insurance prescription amount refers to the total medical care benefit expenses excluding the patient's copayment. However, there is a possibility that it will change during the negotiation process, such as a lawsuit.
- Policy
- NHIS refuses to disclose immunotherapy reevaluation result
- by Moon, sung-ho Feb 15, 2021 06:16am
- Although the National Health Insurance Service (NHIS) has conducted a reevaluation on immunotherapies listed for reimbursement, the government agency decided to keep the outcome undisclosed. On the contrary, the Health Insurance Review and Assessment Service (HIRA) disclosed the outcome of a consignment research done with the same topic. The NHIS’ decision to conceal the outcome has stirred up the relevant industries in South Korea. On Feb. 10, the pharmaceutical and medical industry associates told NHIS has recently injected approximately 250 million won for a year-long research on clinical evidence-based reevaluation on listed immunotherapies, but decided to keep the outcome to themselves. The research was led by the Chairperson of Lung Cancer Committee of Korean Cancer Study Group (KCSG), Professor Ahn Myung Ju at Samsung Medical Center Department of Hematology and Oncology. The study reviewed the treatment efficacy of NHI-listed immunotherapies—Keytruda (pembrolizumab) and Opdivo (nivolumab)—in the real world clinical scene in South Korea, and focused on using the collected data to evaluate the treatments’ cost-effectiveness. The study also designed post-management models by reevaluating the efficacy and cost-effectiveness based on the collected clinical data analysis. According to the study, the agency aims to set up management models based on the NHI finance monitoring. Meanwhile, HIRA also conducted a similar research prior to NHIS. HIRA started the ‘Reevaluation on Immune Checkpoint Inhibitor Treatments’ since 2018, compared to NHIS’ research started from November 2019, and presented the result in the middle of 2019. Coincidentally, the HIRA research was also led by KCSG President, Professor Kang Jin-hyoung at Seoul St. Mary’s Hospital. While the HIRA-sponsored Professor Kang’s research result is open to public, Professor Ahn’s NHIS research is not. Professor Ahn Myung Ju at Samsung Medical Center reserved her comment but said, “From the get-go, NHIS and the researchers agreed to have the research outcome undisclosed. The study would never be open to public. I do not have other comments to make as the consignment contract clarified the confidentiality nature of the study.” But the related industries are disputing over the reasons why NHIS is keeping the research result hidden from the public. Some suspect the government agency feels the pressure of expanding the reimbursement standard to include first-line therapy based on the outstanding analysis result of the immunotherapies. Moreover, the industry’s curiosity is heightening as some industry insiders say the NHIS study touched on wider range of subjects than the HIRA’s. For instance, HIRA’s reevaluation targeted 1,189 patients with advanced or metastatic non-small cell lung cancer (NSCLC), who failed to respond to chemotherapies at top 20 healthcare institutes in South Korea. Apparently, Keytruda and Opdivo’s overall response rate (ORR) demonstrated 35.98 percent and 31.01 percent, respectively, which did not show statistically meaningful difference between those patient groups. However, NHIS research targeted larger patient groups treated from all healthcare institutes around the country. The industry paid a closer attention to the study as it would provide detailed data of the treatments’ efficacy. An oncology department professor, who requested to be anonymous, noted, “The result of a HIRA research on reevaluating immunotherapies was disclosed, whereas the result of a NHIS research on the same topic was turned undisclosed. It is difficult to comprehend the NHIS’ decision. Many of the industry associates think NHIS is silencing the positive reevaluation outcomes of the major immunotherapies’ efficacy.” But NHIS official stated the immunotherapy reevaluation research is undisclosed, because of the principles of the market economy as the research included specific pharmaceutical companies. NHIS also argued there are plenty of other researches kept undisclosed with the similar reasoning. The government agency official added, “In accordance to the Article 9 of the Official Information Disclosure Act, the agency has decided to not open the research result to public, because the details contain various confidential data of specific drugs regarding clinical efficacy and cost-effectiveness.”
- Policy
- Janssen, to close Hyangnam plant in Korea
- by Lee, Tak-Sun Feb 15, 2021 06:16am
- Janssen Korea‘s factory in HyangnamWith the withdrawal of the Hyangnam factory this year, Janssen Korea is reorganizing its domestic product lineup of Tylenol and Ultracet The production of Tylenol 8 hours ER and Ultracet is undergoing a transition or shutdown procedure. According to the MFDS on the 8th, all Ultracet products, an analgesic combination drug containing Tramadol-Acetaminophen, which were produced in the Hyangnam factory, were all converted for export. Accordingly, Ultracet produced at the Hyangnam Plant will soon end its insurance benefits. Ultracet is largely divided into fast-acting tablet typed Ultracet, and sustained-release tablet typed Ultracet ER. It is also divided into Ultracet, Ultracet Semi, Ultracet ER, and Ultracet ER Semi according to the size (the dosage). Janssen Korea’s Ultracet and Ultracet Semi, which were previously produced at the Hyangnam factory, have been converted into export products within the last year. An export item is a product used only for export, not sold in the domestic market. When switching to export, insurance benefits are removed, and insurance claims can be made for six months to close inventory. It will not be sold in the domestic market. Ultracet was converted to an imported product produced at factories in Canada and Italy last May. Janssen of Korea recently sent an official letter to the distribution industry about Ultracet Semi, saying that the provider will be changed to Handok, and that it will be available in June after an administrative procedure. Accordingly, only Ultracet ER and Ultracet ER Semi are produced at Hyangnam Plant. Ultracet ER has a higher sales performance than Ultracet. Based on IQVIA, the cumulative sales for the first half of last year show that Ultracet ER was ₩4.7 billion, Ultracet ER Semi was ₩4.2 billion, Ultracet was ₩2.4 billion, and Ultracet Semi was ₩1.1 billion. As the Hyangnam plant operates until this year and the sale process to Whanin Pharm is completed by March next year, the manufacturer of Ultracet ER products is also expected to change. Janssen Korea is also promoting technology transfer to Handok. Janssen recently sent an official letter to the distributor, saying that it will supply Tylenol 8 hours ER 325mg by April and withdraw. Tylenol 8 hours ER 325mg will be terminated and only Tylenol 650mg will be distributed. Based on IQVIA, the cumulative sales of Tylenol in the first half of last year were ₩12.5 billion, and Tylenol 8 hours ER 325mg was ₩5.7 billion. In August of last year, Johnson & Johnson Korea received a license for Children's Tylenol 160mg from Canada. However, it is not yet known what will happen to Tylenol produced in Korea after the Hyangnam plant is closed.
- Policy
- Drug exempt from economic evaluation,cut to the lowest price
- by Lee, Hye-Kyung Feb 15, 2021 06:16am
- The NHIS continues to monitor foreign drug prices after signing and listing a drug price reduction contract linked to foreign prices for drugs exempt from economic evaluation in accordance with the drug price negotiation guidelines. In the past three years from 2018 to 2020, after 30 items of 14 pharmaceutical companies were listed on the list, they signed a contract stating that drug prices would be reduced if foreign prices lower than the domestic upper limit were confirmed. Among them, 6 items in 2018 and 15 items in 2019 received the lowest price. In particular, from 2019, the number of countries subject to foreign drug price linkages has been expanded from the lowest price of the newly listed country to the lowest price of all countries, and the price fluctuations of not only newly listed foreign drugs but also existing listed drugs have affected the domestic market. Japan, one of the A7 countries, implemented an ICER re-evaluation for registered drugs in April 2019, and drug price adjustments were made. If the price of the registered drugs fell to the lowest A7 due to drug price cuts, it is reflected in Korea,too. The NHIS uses the upper limit price in Taiwan, Singapore, and countries affiliated with the Organization for Economic Development Cooperation (OECD) as a reference price for drug price negotiation in accordance with Article 7 of the Drug Price Negotiation Guidelines. In the case of drugs exempt from economic evaluation, agreements have been made on drug price reductions, such as adjusting the upper limit in conjunction with the lower amount when it is confirmed that the adjusted price is lower than the upper limit for each A7 country. Foreign drug prices referenced by The NHIS can be checked on the website. The NHIS has created a bulletin board for foreign drug price inquiry guidelines since 2019, and has released sites in 38 countries, including OECD member countries and Taiwan and Singapore, which are referring to drug price negotiations.
- Policy
- AstraZeneca vaccine authorized for use in Korea on Feb. 10
- by Lee, Tak-Sun Feb 15, 2021 06:16am
- The COVID-19 vaccine developed by AstraZeneca was finally approved by the South Korean health authority on Feb. 10. The approval is valid for the age group over 18, including elders older than 65. On Feb. 10, South Korea’s Ministry of Food and Drug Safety (MFDS) convened a Final Inspection Committee to make a decision on authorizing AstraZeneca’s COVID-19 vaccine, and officially announced the result. Similar to Celltrion’s anti-COVID-19 monoclonal antibody treatment, the Final Inspection Committee gathered and agreed on a final decision for the vaccine on the same day. Expert Committee meetings were held twice prior to the final meeting and gave a positive result. Previously, the Central Pharmaceutical Affairs Deliberation Committee recommended the vaccine should be given to adults over the age of 18, and the Korea Advisory Committee on Immunization Practices (KACIP), associated under the Korea Disease Control and Prevention Agency (KDCA), should discuss the inoculation for elders aged over 65 due insufficient clinical data. Agreeing to the committees’ recommendation, the Final Inspection Committee authorized the vaccination for the age group over 65. However, the committee also decided to label a warning stating ‘a vaccine user aged over 65 should carefully consider on using the vaccine.’ According to the decision, AstraZeneca’s vaccine became the first COVID-19 vaccine to be officially authorized in South Korea.
- Policy
- On-site judgment is important
- by Lee, Tak-Sun Feb 09, 2021 06:04am
- COVID-19 vaccine by AZ, along with CMA, recommended that those over 65 years of age should review it by the Vaccination Specialist Committee, the Central Pharmaceutical Affairs Review Committee of the MFDS said it was because on-site judgment was important. In a briefing held on the 5th, Chairman Il-Hwan Oh said, "Because the data on the elderly are relatively limited, the MFDS has made a decision to carefully judge the benefits of vaccination and the risks that may occur if not." He said, "The clinical trial results so far are not statistically verifiable because the number of cases has been small. But it doesn't mean that this doesn't work or put a decision on hold" On this day, the Central Pharmaceutical Affairs Review Committee recommended CMA to be used for AstraZeneca’s vaccines over the age of 18, but suggested that vaccinations over 65 years of age should be discussed later at the Korea Advisory Committee on Immunization Practices (KACIP). Accordingly, vaccination for the elderly over 65 will be confirmed by the KACIP after final item approval. Chairman Oh said that the announcement of the results was delayed by one day. He said, “In consideration of the phenomenon that some European countries have various opinions on the administration of the elderly, it was delayed because there were many discussions to verify the level that all the people can understand.”
- Policy
- The Committee recommended AZ vaccine approval
- by Lee, Tak-Sun Feb 09, 2021 06:04am
- The Central Pharmaceutical Affairs Review Committee of the MFDS, which consulted on AstraZeneca's approval of the COVID-19 vaccine, recommended item approval, subject to the submission of ongoing clinical results. In addition, for vaccinations over 65 years of age, it was gathered that opinions should be made carefully in the matters of approval, and that it is recommended to be discussed later in the Korea Advisory Committee on Immunization Practices. The Central Pharmaceutical Affairs Review Committee held a meeting at the Osong headquarters of the MFDS on the 4th and made this decision. According to the MFDS, The Central Pharmaceutical Affairs Review Committee recognizes the need for the domestic COVID-19 prevention purpose of the applied item, and submits the results of clinical trials currently in progress when synthesizing the consultation results of the COVID-19 vaccine safety and effectiveness verification advisory group. It advised that item approval is possible on the condition of that. The dose and interval should be judged based on scientific verification, and it was possible to administer twice the applied dose at intervals of 4 to 12 weeks whose efficacy was confirmed, considering the standard dose and administration interval and two doses planned in the clinical trial. As for vaccination of elderly patients 65 years of age or older, the same as in Europe, they should be 18 years of age or older. It was also recommended to submit analysis data on the results of US clinical trials later. At the same time, and it is recommended to be discussed at the KACIP later. Regarding the safety of the vaccine, the safety profile (trend), such as adverse events that occurred in clinical trials, is acceptable, but the opinion that the occurrence of nervous system-related adverse events, including transverse myelitis, should be monitored after approval. Inoculation for pregnant women is not recommended, and for nursing mothers, it is appropriate to state in the precautions for use that'it is not known whether this drug is secreted into breast milk', he said. At the Central Pharmaceutical Affairs Review Committee meeting, 12 standing members of the Subcommittee on Biological Medicines, 5 verification advisors, 1 expert recommended by the Korea Medical Association, 7 members of the Vaccine Review Team, Clinical Review Team, and Quality Review Team attended the COVID-19 Crisis Response Support Division inside the MFDS. Previously, a verification advisory group composed of experts supported the approval of the AstraZeneca's COVID-19 vaccine, and recommended that elderly patients not be restricted. The Central Pharmaceutical Affairs Review Committee allows the administration of the elderly, but takes a more cautious approach and delays the decision to the Korea Advisory Committee on Immunization Practices in the future. Based on this consultation, the MFDS is planning to convene a final inspection committee to make a final decision on whether to approve AstraZeneca's COVID-19 vaccine.
- Policy
- Will the Committee allow AZ vaccine in the elderly?
- by Lee, Tak-Sun Feb 08, 2021 06:08am
- This is because the Central Pharmaceutical Affairs Review Committee, a specialized advisory body for the MFDS, determines the adequacy of the approval from 2pm. While it is expected that the Central Pharmaceutical Affairs Review Committee has decided on item approval, it is noteworthy how it will decide on the administration of the elderly. Earlier, the 1st expert meeting, Verification Advisory Group, suggested the use of the vaccine, saying, "There is no reason to exclude the administration of AstraZeneca’s vaccine to the elderly." The MFDS will hold an advisory meeting on the Central Pharmaceutical Affairs Review Committee for AZ Vaccine in a conference room at the headquarters in Osong, Chungbuk at 2 pm on the 4th. The MFDS is holding expert meetings three times in the case of COVID-19 vaccines and treatments. Final approval is decided through the first verification advisory group, the second Central Pharmaceutical Affairs Review Committee, and the third final review committee. In general, the agenda has been decided mostly through the Central Pharmaceutical Affairs Review Committee. In consideration of public interest and securing trust in screening for COVID-19 vaccines and treatments, the expert meeting was increased three times. However, since the committee has made a final decision, it seems that the approval of AZ vaccine will be decided through this meeting. The number of participants in AZ's COVID-19 vaccine clinical trial (UK and Brazil) was 8,895 adults over the age of 18 (4,440 vaccine groups, 4,455 control subjects). The average age was 42.2 years old, and 7.4% (660 people) of the elderly over 65 years old verified the effectiveness. Some European countries have recommended vaccination restrictions due to the fact that there are fewer seniors in clinical trials. Authorities in Germany, France, Sweden, Austria, Poland, Italy and Belgium recommended that older people should limit vaccination. However, the European Medicines Agency (EMA), which oversees drug approval in EU countries, did not place any restrictions on the administration of AZ vaccine to the elderly. The verification advisory group, who first consulted on whether or not to obtain permission in Korea, also stated that there was no reason to exclude the administration of the elderly. At the verification advisory meeting held on January 31 of last month (including 8 infectious internal medicine specialists, clinical statistics specialists, etc.), a number of experts said, "It is impossible to rule out administration to the elderly just because the number of elderly persons among the participants is small." However, some opinions suggested that the administration of the elderly aged 65 or older should be decided through additional clinical trials. A number of experts from the advisory group said, "In the clinical trial of the AstraZeneca’s vaccine, the prevention effect was confirmed in all subjects, including over 65 years of age, and the immune response after white administration is similar to that of adults and the safety profile is good." A small number of experts say that the preventive effect has not been proven due to lack of data, and that the antibody titer is lower than that of adults under the age of 65 and that the correlation between the immunogenic response and the preventive effect has not been established. In the end, according to the majority opinion, the verification advisory group recommended that vaccination is possible even for elderly people over 65 years of age. The meeting is expected to involve more experts than the verification advisory group. Earlier, a total of 18 people, including members of the verification advisory group, attended the Central Pharmaceutical Affairs Review Committee of Celltrion's COVID-19 treatment Rekirona. The results of the Central Pharmaceutical Affairs Review Committee meeting in Rekirona were different from that of the Verification Advisory Board. While the verification advisory group determined that it could be used for all mild patients, the Central Pharmaceutical Affairs Review Committee recommended that only high-risk patients be allowed among mild patients. Therefore, even at the Central Pharmaceutical Affairs Review Committee meeting of AZ’s vaccine, the possibility of results contrary to the previous verification advisory's position to allow the administration of the elderly cannot be excluded. It is analyzed that there is a high probability that a similar decision will be made in Korea as the European EMA, the agency most trusted by the MFDS, has not placed restrictions on vaccination for the elderly. If AZ vaccine is limited to the administration of elderly people, the vaccination plan should be changed. This is because most of the vaccines vaccinated in the first quarter are AZ vaccine. In particular, elderly people in nursing hospitals have difficulty in getting the Pfizer vaccine, which is introduced in mid-February because of their mobility. Pfizer vaccines require frozen storage and can only be inoculated at specific centers.
- Policy
- Government-pharmaceutical organizations discuss measures
- by Lee, Jeong-Hwan Feb 08, 2021 06:07am
- The MOHW and medical groups discussed COVID-19 vaccination plan and comprehensive measures to strengthen health insurance non-reimbursement management. The operation plan of the Health and Medical Personnel Policy Deliberation Committee was also on the agenda of the meeting. On the 3rd, the MOHW (Minister Kwon Deok-cheol) held the 4th working-level meeting with pharmaceutical organizations at the Korea Health Promotion Institute. It was attended by Health and Medical Policy Officer Lee Chang-joon of the Ministry of Welfare, Health and Medical Policy Manager Kim Kook-il, Medical Personnel Policy Manager Kim Hyun-sook, Medical Security Management Manager Gong In Sik, and Health Care Innovation Team Leader Jeong-min Yoo. The KHA Vice Chairman Song Jae-chan, the KDA Vice Chairman Hong Soo-Yeon, the AKOM Vice Chairman Lee Jin-ho, the Korean Pharmaceutical Association Vice Chairman Kim Dong-geun , and the Korean Nurses Association Vice Chairman Kwak Wol-hee were seated. The agenda of the meeting includes comprehensive measures to strengthen health insurance non-reimbursement management, organization and operation plan of health care personnel policy deliberation committee, operation plan of health care personnel support agency, progress of mid- to long-term health care personnel supply and demand estimate, and COVID-19 vaccination implementation plan (draft). Lee Chang-joon said, "We will provide necessary information to patients for effective non-reimbursement management, while discussing ways to minimize the burden on medical institutions and medical personnel, and continue to collect opinions from the medical community and related organizations." said. He explained, "The Health and Medical Personnel Policy Deliberation Committee was organized to reflect the opinions of various roles and classes." This policy officer said, “We will closely discuss the training and supply and demand management of health care personnel, measures to improve the treatment environment, etc. with related ministries, related organizations, and experts. To secure medical personnel necessary for COVID-19 vaccination, education, and designation of a consigned medical institution, etc., Active cooperation with organizations is necessary. The Health and Medical Development Council will actively discuss tasks that are difficult to resolve due to conflicts of interest between the direct sectors and produce results of the operation of the consultative body."
- Policy
- Phase III fast track for Leclaza·Lynparza was approved
- by Lee, Jeong-Hwan Feb 05, 2021 05:54am
- While a bill was proposed to upgrade the fast track system in phase III to the pharmaceutical affairs law from the public announcement, 62 new drugs were counted to have taken the fast track so far. Most of domestic and overseas anticancer drugs such as Leclaza (Lasertinib) developed by Yuhan, AstraZeneca's Lynparza, Tagrisso (Osimertinib), and Pfizer's Ibrance (Palbociclib), are fast tracked. Biosolution's CartiLife and Tego Science’s Rosmir were also included. On the 4th, the drugs approved by the MFDS for Phase III clinical trial, including drugs related to rare diseases and intractable diseases, as well as anticancer drugs and cell therapy drugs, received special cases of fast track. The CMA system is currently being operated by the MFDS with notice and internal guidelines (guidelines). In particular, the MFDS recently announced a revision of the licensing and management guidelines to improve the predictability of the CMA system in phase III clinical trial. It specifies the target of the fast track in detail, includes the evidence when setting the deadline for submission of the clinical plan, and describes whether or not the Central Pharmaceutical Affairs Review Committee needs consultation. When item approval, the conditions of permission were to be described in the permission details. In addition, the National Assembly is also pursuing a legislation (People Power Party, Jongheon Paik) to upgrade the CMA system of the MFDS to the pharmaceutical affairs law. Among 62 new drugs that followed the CMA track, Leclaza is the 31st domestic drug. Non-small cell lung cancer Leclaza 80mg is the 62nd CMA drug. Leclaza has been transferred to Janssen, a global pharmaceutical company, and is undergoing licensing procedures in other countries such as the United States. AstraZeneca’s ovarian cancer drug Lynparza, Novartis’ metastatic breast cancer drug Kisqali, and Biosolution’s osteoarthritis drug CartiLife were also approved for CMA. Lynparza, Kisqali and CartiLife, excluding Leclaza, were approved on January 18 this year, were CMA in 2019. Takeda Pharm's ALK-positive non-small cell lung cancer drug Alunbrig (Brigatinib), Tego science's sub-eye wrinkle improvement cell therapy Rosmir, soft tissue sarcoma drug Lartruvo (Olaratumab), Roche immune anticancer drug Tecentriq (Atezolizumab) and ALK-positive non-small cell lung cancer drug Alecensa (Alectinib), Pfizer's breast cancer drug Ibrance (Palbociclib) is also conditionally approved for phase III clinical trial. Hanmi’s Olita (Olmutinib), which was decided to discontinue marketing on September 30, 2016 due to a side effect of severe skin disease, also took the CMA track, and clinical trials are in progress even when the market is suspended. Eisai's Symbenda 25mg and 100mg are selected as treatments for which indications have been deleted due to failure to meet conditions such as submission of data for phase III clinical trials after CMA. Symbenda did not fulfill the condition and the indication was removed. GemVax & KAEL’s pancreatic cancer treatment Riavax was also delayed in submitting the result report for phase III clinical trials, so the MFDS decided to cancel its license. However, Samsung Pharm, who took over Riavax, objected to the disposition of the MFDS and applied for suspension of administrative disposition. Ilyang’s Supect (Radotinib) 100mg/200mg were also administered administratively. Pharmaceuticals that fulfilled the conditions for data submission in phase III include Boehringer Ingelheim's non-small cell lung cancer drug Giotrif (Afatinib) 20/30/40 mg, Amgen's bone giant cell tumor treatment Xgeva (Denosumab), Chong Kun Dang's CamTOBELL (Belotecan). For CMA drugs that have not completed the submission of data for phase III clinical trial, they are expected to submit final clinical results within the deadline reported to the MFDS. The MFDS is planning to actively approve the advancement of the CMA system by revising the internal guidelines and the handling of the CMA upgrade bill initiated by Jong-Heon Paik.
