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- 2025-12-23 22:26:41
- Policy
- Keytruda to be reimbursed as first-line treatment for NSCLC
- by Lee, Tak-Sun Feb 22, 2022 05:54am
- A new category will be added to reimburse MSD’s NSCLC treatment ‘Keytruda’ as a first-line treatment. This is the first anticancer immunotherapy released in Korea to be reimbursed for NSCLC, five years into its approval as a first-line treatment for non-small-cell lung cancer in Korea. The drug passed deliberations by the Health Insurance Reimbursement and Assessment’s Drug Reimbursement Evaluation Committee, which decided to extend the national health insurance coverage for Keytruda as first-line treatment for NSCLC. HIRA announced the results above while collecting opinions on the 'revisions on the announcement made for drugs prescribed and administered to cancer patients' on the 18th. The revisions showed that a new reimbursement category has been added for Keytruda as first-line therapy and will take effect from March. Keytruda is a cancer immunotherapy drug that specifically binds to PD-1 (programmed death 1) proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 proteins existing on the surface of tumor cells and induces T cells to attack the tumor cells. Therefore, the drug can be used in various cancer patients with PD-L1 expression and was approved as a first-line treatment in Korea in March 2017 for the treatment of metastatic NSCLC. However, its reimbursement did not gain momentum until last year, when the agenda passed HIRA’s Cancer Disease Review Committee and then passed DREC review in January this year. In the proposed revision, Keytruda can now be reimbursed as ▲first-line treatment for PD-L1 positive (Tumor Proportion Score (TPS)≥50%), advanced NSCLC (Stage IV) patients with no EGFR or ALK mutation, ▲ first-line treatment of metastatic nonsquamous NSCLC patients with no EGFR or ALK mutation in combination with pemetrexed platinum-based chemotherapy, ▲ first-line treatment of metastatic squamous NSCLC patients in combination with pemetrexed or paclitaxel (or albumin-bound paclitaxel), ▲as monotherapy for the treatment of adult patients and pediatric patients aged 2 years or older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have relapsed after at least two types of therapy or failed or is ineligible for allogeneic hematopoietic stem cell transplantation (HSCT). This is the first time a cancer immunotherapy is reimbursed as a first-line treatment for NSCLC. A clinical trial conducted on NSCLC patients as monotherapy for the reimbursed indication showed that its median OS was 30 months and median PFS 10.3 months, both better than the control group (14.2 months, 6.0 months), raising expectations on the treatment effect the drug will bring to the field. The ORR in the Keytruda-treated group was 69%, higher than the 42% of the control group. A qualitative improvement is expected in the field of NSCLC treatment in general with the increased treatment options and the improved patient access to new options. Meanwhile, the revision also added a new reimbursement standard for the acute myeloid leukemia (AML) treatment ‘Xospata (Astellas, gilteritinib).’ A new reimbursement standard will be added for the second-line or higher use of Xospata as monotherapy in patients with FLT3 mutation-positive relapsed or refractory AML.
- Policy
- Required PMS case reports reduced for Genvoya and Descovy
- by Lee, Hye-Kyung Feb 21, 2022 05:58am
- The number of evidence cases reported for post-marketing surveillance of HIV treatments ‘Genvoya tab (emtricitabine / tenofovir alafenamide/ cobicistat / elvitegravir)’ and ‘Descovy tab (emtricitabine / tenofovir alafenamide) that are subject to reevaluation will be adjusted. Genvoya and Descovy, which received marketing authorization from the Ministry of Food and Drug Safety in September 2016 and February 2017, respectively, are up for reexamination by September 12th and have been conducting post-marketing surveillance for 6 years since their release. The PMS cases that were required for the report are 3000 cases for Genvoya and 600 for Descovy, but the Central Pharmaceutical Affairs Council saw consensus on the need for the number of cases to be adjusted to 1,430 and 460 for each. The results were detailed in the minutes of the CPAC meeting disclosed recently by the Ministry of Food and Drug Safety. The committee members have judged that the number of evidence cases reported should be adjusted in consideration of the indications and the reduced sales for Genvoya, and the refunds and characteristics of its indication for Descovy. ◆Descovy = In detail, the committee chair of the safety and pharmaceutical reexamination review subcommittee explained that when a new standard-of-care is introduced, the number of new patients taking the drug decreases while the number of HIV-positive patients remains the same, the 600 PMS cases required for Descovy may not be realistic. The MFDS said, “The drug was not designated an orphan drug due to the availability of various alternatives. As setting a fixed number, 3,000 or 600, unilaterally on drugs rose as an issue, the company is allowed to present an appropriate number of evidence cases for the report in the process of determinations, but as the actual market situation may change, the number is often later adjusted according to the market situation. The explanation came after the inquiry on why AIDS treatments do not fall into the category of rare diseases when the number of AIDS patients was 14,000. A committee member said, “The number of PMS cases for submission should be reviewed and applied consistently within the ministry. A standard should be set internally to adjust the number of PMS cases.” Some had raised the opinion that AIDS treatments should be reviewed from a different standard than other general medicines when setting the number of required evidence cases for examinations. Another committee member said, “Due to the small number of patients and short duration of the drugs, it is hard to collect cases according to regulations. The short duration of action of the drug and the number of patients are not being considered. Since the additional investigation period will not help increase the number of collected cases, it would be better to close the re-examination within the set period and sort out the side effects as soon as possible.” ◆Genvoya = Both Descovy and Genvoya are Gilead Science Korea’s products, and the committee members focused on the fact that was the same company has been supplying improved follow-on STR formulation. The committee saw that the fact that the company supplies both the product subject to case number adjustments and follow-on products was an important factor and that the pharmaceutical company is leading the market by focusing on marketing its follow-on drug. The committee members weighted on the fact that the reason why Descovy and Genvoya cannot collect the number of required cases is that the market share has shifted with the release of its follow-on drugs. Another member said, “The follow-on drug will also be subject to reexaminations, and we should require the company to fill the number of evidence cases early on in those subject to the PMS. As the PMS should be conducted in patients who are new users of the drug, the company may apply for another adjustment without the allowance of retrospective studies." To this, some members had suggested that cases in the retrospective studies should also be included as PMS cases for submission. A member said, “There may be distortions in the retrospective survey depending on the patient's memory, but as the collection of results for the retrospective study is based on medical records, there will be no major distortions. We need to accept retrospective study results.” However, the MFDS said, “The PMS is conducted to monitor all adverse events. There is still room for data distortion with retrospective investigations.” The committee was able to reach an agreement on adjusting the number of cases, the members were unable to reach an agreement due to discord on filling the number of cases with retrospective studies. The chair of the committee said, “We ask the MFDS for more thorough supervision of the latecomer drugs developed and prepared by the pharmaceutical companies that developed the originals so that the companies could fully concentrate on PMS in the early stages after release.”
- Policy
- Pre-registration of Novavax vaccination will begin
- by Kim, Jung-Ju Feb 21, 2022 05:58am
- The quarantine authorities will start pre-registration of Novavax vaccinations for adults over the age of 18. According to the COVID-19 vaccination promotion team, adults over the age of 18 who want to receive Novavax can make reservations through (http://ncvr.kdca.go.kr). Elderly people who have difficulty making reservations on their own can make proxy reservations through the website or make phone reservations (1339, local government call centers). Those who have completed the pre-booking will be able to get vaccinated on the day of reservation at consigned medical institutions nationwide (about 12,900 locations) from March 7, and the second inoculation date will be automatically booked three weeks after the first inoculation. However, the inoculation date cannot be selected as a date two weeks before the reservation date. For example, if people make a reservation on February 21, they can choose after March 7, and if people make a reservation on February 22, they can choose after March 8. People can get vaccinated on the same day by booking a remaining vaccine on Kakao Talk and Naver, or putting the name on the preliminary list after checking by wire with a medical institution. The authorities plan to allow vaccinations on the same day through the amount held by all consignment agencies after March 7 so that vaccinations can be conveniently received without prior reservations. Cross-vaccination and 3rd vaccination using Novavax vaccine are also possible. 2nd vaccination should be inoculated with the same vaccine as primary vaccination, but cross-vaccination through Novavax vaccine is exceptionally possible if MD determines. In the case of basic vaccination with Novavax vaccine, the third vaccination is based on Novavax vaccine, and the vaccination interval is three months after the completion of the second vaccination. However, there are two exceptional cases. In the first case, a person who has received a basic vaccination with Novavax vaccine wishes to receive 3rd vaccination with mRNA vaccine, and can be vaccinated without any special reason. The second is the case where a person who received basic vaccination with a vaccine other than the Novavax vaccine has a reason for contraindication or postponement during the basic vaccination, and a third vaccination is possible with an exception under the judgment of a doctor. The authorities are conducting door-to-door vaccinations for non-invaccinated people such as ▲ hospitalized patients, ▲ residents of nursing facilities, ▲ elderly people with severe disabilities, etc. It is expected to contribute to reducing the number of severely ill patients and protecting high-risk groups by eliminating vaccination blind spots for high-risk groups that were not vaccinated due to physical constraints. The promotion team said, "As vaccination can reduce the risk of COVID-19 infection in the community and effectively prevent severe progression, we ask those who have not yet been vaccinated to actively participate in the pre-reservation for Novavax vaccination."
- Policy
- Tagrisso’s succeeds in RSA renewal… 3% price cut per dose
- by Kim, Jung-Ju Feb 18, 2022 05:55am
- AstraZeneca’s NSCLC treatment Tagrisso (Osimertinib) succeeded in renewing its risk-sharing agreement (RSA) with the National Health Insurance Service, and the price of the drugs will be adjusted and discounted by 3% per dose. According to industry sources, AstraZeneca has agreed to discount the insurance price of Tagrisso during RSA renegotiations with the NHIS. With the MOHW working to amend the ‘drug reimbursement list and reimbursement ceiling price table’ to implement these changes. If the amendment is finalized, it can be applied from March 1st. Leclaza is reimbursed for second-line treatment of lung cancer, for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with positive EGFR T790M mutation who have been previously treated with an EGFR-TKI. The drug also has indications as first-line therapy and as adjuvant therapy after complete tumor resection. With the expiry of the first RSA term, the price of the drugs will be discounted by 3% each. The 30mg dose will be discounted from ₩116,563 to ₩113,066, and the 80mg dose from ₩217,782 to ₩211,248.
- Policy
- What is the pledge of the presidential candidates?
- by Lee, Jeong-Hwan Feb 18, 2022 05:54am
- Democratic Party of Korea Lee Jae-myung (left), the power of the people, Yoon Seok-yeolWith the 20th presidential election day just 20 days away, candidates from each party completed submitting their teenage pledges with the registration of candidates for the National Selection Commission on the 13th. The main keyword for the health care pledge of Democratic Party of Korea Lee Jae-myung, the power of the people Yoon Seok-yeol, Ahn Cheol Soo of the People's Party, and Sim Sang Jung of the Justice Party is "overcoming COVID-19." Lee Jae-myung promised to secure sovereignty in domestic development vaccines and treatments and establish a public production system for essential medicines based on the strengthening of the all-out response system to the spread of COVID-19 variants such as Omicron. Lee Jae-myung plans to strengthen his ability to respond to infectious diseases by securing sufficient public hospitals and public medical personnel. Earlier, he said he would also implement policies to apply health insurance for hair loss treatments and legislate CCTVs in operating rooms, which he had pledged to "small situations" and Lee Jae-myung's definite happiness). Candidate Yoon Seok-yeol of the People's Power pledged to immediately operate an emergency rescue program by setting up a "COVID-19 Emergency Rescue Special Headquarters" directly under the president's office. Candidate Yoon established a policy fee in the health insurance benefit system to strengthen periodic pandemic responsiveness and announced the realization of a national responsibility system for essential medical care. It also reaffirmed its pledge to strengthen the requirements for foreign health insurance subscribers to register dependents and prevent theft of their names. Candidate Yoon is also expected to apply health insurance for consecutive blood glucose meters for diabetic patients, expand mobile telemedicine for military personnel, and make it mandatory to check health insurance recipients of medical institutions. Candidate Ahn Cheol Soo The People's Party stands out in the health and medical field for pledges such as safe welfare by life cycle, lowering the price of hair loss generic drugs, and the state responsibility system for mental health. Candidate Ahn promised to raise 3 trillion won to 5 trillion won in finances used to abolish standards for livelihood and medical benefits in order to link and treat high-risk groups for depression by adding mental health checkups to the entire nation. Candidate Sim Sang Jung Justice Party put the so-called "Sim Sang Jung Care" at the forefront of the pledge, which guarantees the right to health for the people by expanding public health care and setting an annual cap of 1 million won for hospital expenses. From the cradle to the grave It is determined to ensure the care of the whole people. As a way to implement Sim Sang Jung care, the government has proposed the expansion of public health care, guaranteeing essential severe medical care by region, upper limit on hospital expenses, and realizing health advanced countries such as the family doctor system. In detail, it promised to establish a system for training public doctors and public nurses by establishing the National University of Medicine and public medicine, and to expand health care personnel to the OECD level. It also said it would conduct a health impact assessment on all government policies with the establishment of the Ministry of National Health.
- Policy
- Rybrevant has been approved in Korea
- by Lee, Tak-Sun Feb 17, 2022 05:52am
- Janssen's Rybrevant, which is conducting a combined clinical trial with Leclaza, a new non-small cell lung cancer treatment drug developed by Yuhan Corporation, has been approved in Korea. The MFDS approved Janssen's Rybrevant on the 15th. This drug is used for "the treatment of patients with local progressive and metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in which the disease progressed during or after platinum-based chemotherapy." The recommended dosage also varies depending on the patient's weight with intravenous injections. The drug is drawing particular attention because it is conducting clinical trials in combination with Leclaza of Yuhan Corporation, a new domestic development drug, in the global market. Lazertinib exported technology worth 1.4 trillion won to Janssen in 2018. Since then, Janssen has been conducting clinical trials on non-small cell lung cancer patients using Lazertinib and its own developed Amivantamab. Two phase 3 clinical trials are underway in Korea. The phase 3 clinical plan was approved in September 2020 as the first treatment for patients with EGFR mutant local progressive and metastatic non-small cell lung cancer. In December of last year, EGFR-mutant, which failed Tagrisso treatment, entered phase 3 clinical trials for patients with local progressive and metastatic non-small cell lung cancer. Tagrisso is a third-generation treatment for EGFR mutated non-small cell lung cancer, and is a large drug with annual sales (based on IQVIA) exceeding 100 billion won in Korea. Leclaza and combination therapy of Leclaza-Amivantamab are expected to be competitive drugs for Tagrisso. Lazertinib expects conditional approval from the U.S. FDA this year as a second and third treatment for non-small cell lung cancer. In addition, combination therapy of Amivantamab-Lazertinib also challenges FDA approval. Rybrevant was approved by the MFDS as a GFR exon20 mutant non-small cell carcinoma treatment, but it was also approved by the U.S. FDA as a therapy that blocks epithelial cell growth factor (EGFR) and MET mutations at the same time.
- Policy
- Revised the method of Rx notes for health functional foods
- by Lee, Jeong-Hwan Feb 17, 2022 05:52am
- Regarding the regulation of "Note Prescription of Health Functional Foods," the MFDS expressed its position to push for legislation after watching the operation of the prohibited regulation that the health functional food industry voluntarily announced. The government plans to steadily monitor the operation of fair competition rules, draw up policies to support voluntary improvement in the health functional food industry, and review the need to revise health functional foods in earnest according to the results. This is the result of examining the prescription management plan for health functional food submitted by the MFDS to the National Assembly's Health and Welfare Committee on the 13th. Representative movements to pay attention to in order to improve the practice of prescribing health functional foods are the legislation of the National Assembly and the enactment of fair competition rules in the Fair Trade Commission and the Health Functional Food Industry. In the case of legislation, Rep. Kim Woni of the Democratic Party of Korea has proposed a revision to the medical law, and the Fair Competition Rules will take effect in April, discussed by the Fair Trade Commission and the KHSA. The revision to the Medical Service Act stipulated that doctors and medical institutions are not allowed to receive rebates such as money and entertainment provided by health functional food companies. The Fair Competition Rule is a method in which the health functional food industry voluntarily imposes penalties of less than 10 million won and heavy penalties of less than 100 million won when detecting rebates such as expedient health functional food note prescriptions. Some worry that the revision of the Health Functional Food Act should be promoted separately from the revision and enforcement of the Fair Competition Rules to regulate the prescription of health functional food, but the MFDS, which is in charge, is in a position to watch the operation of the Fair Competition Rules. Although the MOHW and the specialized committee of the Health and Welfare Committee expressed their position that the Health Functional Food Act needs to be revised prior to the revision of the Medical Service Act, the MFDS insisted that the need to revise the law be slowly considered. The MFDS argued that medicines and medical devices also implemented fair competition rules in the industry first and then revised related laws over a period of time. In the case of medicines, the Pharmaceutical Affairs Act was revised in 2010 after the enactment of the protocol in 1994, and the MFDS explained that the Medical Device Act was revised in 2013 after the enactment of the protocol in 2011. The health functional food-style note prescription does not directly affect health insurance finances, and unlike medicines and medical devices, the reality that health functional foods have open consumer options also affected the direction of the MFDS' policy operation. As a result, it is expected that the revision of the Health Functional Food Act will become a reality depending on the results of the enactment and enforcement of fair competition rules in the health functional food industry this year. The MFDS said, "We will continue to monitor the operation of fair competition rules while supporting voluntary improvement in the industry," and explained, "According to the results, we will review the need to revise the Health Functional Food Act." Health functional foods have a variety of sales channels such as the Internet, large discount stores, pharmacies, multi-level, door-to-door sales, and home shopping, so consumers can choose them, and medicine and medical devices have also been revised since the enactment of the rules, the MFDS added.
- Policy
- Lee to pledge ‘incentives for homegrown new drugs'
- by Lee, Jeong-Hwan Feb 16, 2022 05:51am
- Presidential candidate Jae-Myung Lee of the Democratic Party of Korea is positively reviewing reinforcing incentives for new drugs that were developed by Korean pharmaceutical companies or conducted trials in Korea, establishing a megafund for the pharmaceutical industry, and introducing a pre-approval system for prescriptions of ultra-high priced drugs as pledges for the coming presidential election this year. Also, the candidate is preparing to set official pledges on establishing a public electronic prescription system, institutionalize government support for public late-night pharmacies and complete eradication of hospitals owned by non-medical personnel. The pledges above were those requested by the domestic pharmaceutical industry, pharmacists’ association, and medical field and gained consensus from the NA Health and Welfare Committee. Lee plans to disclose the details of the policy in line with the official electioneering period that starts on the 15th. Lee is known to be reviewing various specific healthcare policies that require expertise regarding non-face-to-face treatment, biopharmaceutical industry, and pharmacy industry, in addition to the public healthcare pledges that he repeatedly announced including the expansion of public hospitals and reinforcing public medical personnel. In particular, the candidate is known to have drawn a relatively detailed blueprint on the development of homegrown vaccines that have greatly increased in importance due to the prolonged COVID-19 pandemic, public manufacture of essential medicines, and national support for the pharmaceutical and bio-industry are being. More specifically, the candidate is likely to make pledges to increase the vaccine self-sufficiency rate of vaccines in the National Immunization Program and strengthen the financial and administrative support needed for the treatment of COVID-19 vaccine and treatments while building a public manufacturing system for essential drugs that are at risk of supply disruption due to low profitability. Also, the candidate is considering incentive systems and active state-driven investment in the pharmaceutical and bio-industry to make Korea a pharmaceutical and biopharmaceutical powerhouse. Lee’s plan is to establish create a public-private matching-fund type megafund to improve the support system for clinical trials and realign the compensation system for homegrown new drugs and clinical trials conducted in Korea. Also, enhancing patient access to new drugs and pre-approval system for prescriptions of ultra-high-risk or ultra-high-priced drugs are being considered as pledges. The pledges above were those that multinational pharmaceutical companies with subsidiaries in Korea had continuously requested to the National Assembly and the government. In particular, the policies requested by Korea Pharmaceutical Association and pharmacists around are also expected to be included in Lee’s pledge. Policies that establish a system for non-face-to-face healthcare that has been temporarily approved due to COVID-19 and promote a state-led public e-prescription system, and policies to expand accessibility and convenience to medication for patients with public late-night pharmacies. The state-led public electronic prescription transmission system has been a policy that KPA had requested for several years now. The public late-night pharmacies are being piloted this year after securing a budget the previous year. Lee’s aim is to expand this pilot project into a main project. In addition, to completely eradicate hospitals owned by non-medical personnel, pledges to allow judicial police power to the NHIS, voluntary reporting, immunity for whistleblowers, stronger report rewards, punishment for those who made illegal establishments, and stronger recovery of unlawful profits are also expected to be included in the manifesto. Also, Lee’s camp promised to fully include ‘small/clear happiness pledges’ Lee had made as health insurance reimbursement of hair loss treatments, contraception, and abortion, free vaccination of HPV vaccines in adolescents, and soft landing the legalization of CCTVs in the operating room. An official from Lee’s camp said, “The camp is busy making additional modifications and final touches to the manifesto. We are in the healthcare pledges are in the final stages, and review the general improvements required in healthcare from public Healthcare to pharmaceutical and bio-industry, to patient systems at hospitals and pharmacies in Korea. The official added, “due to the diverse and multifaceted range of pledges that are being discussed by Lee’s camp, some have been producing false news that Lee excluded the reimbursement pledge for hair loss drugs based on the draft prepared by the camp. The completed pledge manifesto will be disclosed on the 15th when the official election campaign begins."
- Policy
- There's plenty of COVID-19 PO medicine, Regkirona
- by Lee, Jeong-Hwan Feb 16, 2022 05:51am
- The quarantine authorities said they have secured sufficient supplies of COVID-19 oral treatments in Korea and will continue to consider additional purchases depending on the quarantine situation. The quarantine authorities also said they would consider using the budget for purchasing Regkirona as an oral drug as Regkirona, an antibody treatment for COVID-19, is known to be vulnerable to responding to Omikron mutations. On the 14th, the KDCA responded in writing to the National Assembly's Health and Welfare Committee's Seo Young-seok of the Democratic Party and Lee Jong-sung of the People's Power. Rep. Seo asked if it was possible to secure PO drugs such as Paxlovid and expand the number of additional prescriptions. He also inquired about plans to expand the pharmacy in charge. The KDCA replied that it has pushed for a purchase contract for 1,044,000 people in consideration of the spread of Omicron and the quarantine situation. The KDCA has signed a purchase contract Pfizer vaccine (for 762,000 people) and MSD vaccine (for 242,000 people). The KDCA also said it will continue to consider the need for purchase by comprehensively considering the quarantine situation, medical response, development status of domestic and foreign treatments, and clinical efficacy. The KDCA explained that it has been steadily expanding and operating prescription agencies and pharmacies in charge after bringing PO drugs into Korea on the 14th of last month, and that the criteria for those subject to administration have also been expanded. The KDCA replied, "We will continue to improve for a stable supply so that the treatment to be eaten can be administered quickly and safely to those who need it." Rep. Lee Jong-sung said that the budget set for the purchase of Regkirona, an antibody treatment, should be changed to the budget for additional purchase of oral drugs effective in omicron mutations.bThe KDCA agreed with Rep. Lee and replied that it would consider ways to use Regkirona's purchase cost for oral medicine. Specifically, the KDCA set aside 393.3 billion won in the main budget this year, and 3.4 billion won in the purchase of Regkirona. As a result of the Regkirona pharmacological test on mutants, it was evaluated that they were less likely to show activity in omicron mutations, so they should be careful when prescribing them. Accordingly, the KDCA plans to allow the purchase of Regkirona to be used as the purchase of PO drugs in response to Omikron. The KDCA said, "We have not yet signed a contract for Regkirona purchase cost of 3.4 billion won this year," and added, "We will consider securing PO treatments effective for Omicron mutations."
- Policy
- High-dose ‘pyridoxine’ to be classified as an Rx drug
- by Lee, Hye-Kyung Feb 14, 2022 05:54am
- The high-dose Vitamin B6 ‘Pyridoxine Hydrochloride 300mg’ is likely to be classified as a prescription drug. Although pyridoxine doses up to 250mg are classified as a health functional food abroad, experts reached a consensus that the 300mg dose of the same drug should be classified as a prescription drug in consideration of the side effects that arise from the long-term use of the higher dose, and similar cases where a low-dose formulation of an approved drug had been classified as an OTC and the high-dose formulation as an ETC. The Ministry of Food and Drug Safety disclosed the minutes of the meeting held by the drug classification subcommittee of the pharmaceutical policy committee under the Central Pharmaceutical Affairs Council that was held on January 17th. In Korea, pyridoxine may be taken up to 100mg as an OTC, up to 250mg under the Korean manufacturing standard for medicine, and up to 67mg as a health functional food. The product that was under review this time is a high-dose formulation that contains 300mg of pyridoxine. Other than in Japan which classified the 300mg high-dose formulation as a prescription drug, other countries have classified the same drug as a health functional food or OTC. However, the subcommittee members were skeptical about the classification of high-dose pyridoxine as an OTC due to concerns over its side effects and duration of use. In particular, the members reached a consensus that it is reasonable to classify the high-dose formulation as a prescription drug as the high-dose pyridoxine is used for conditions that require diagnosis, such as to prevent deficiencies arising from the administration of Vitamin B6 antagonists and the treatment of B6 dependence, in addition to well as the side effects that may arise. Also, some raised the opinion that the 300mg needs to be classified as an ETC for the safe use of the drugs in consideration of cases where the lower dose was approved as an OTC and the higher dose was approved as ETC. Regarding its efficacy and effect, some members pointed out that although the 300mg formulation is not expected to be sold as a nutritional supplement the standard between the health functional food and OTC was unclear as the same ingredient is approved as a health functional food up to 67mg/day, and as OTC up to 100mg/ day. To the question where dosages other than the 300mg high-dose formulation that is under review may be reviewed for classification as OTC/ETC, the MFDS responded that such cases would require a separate application for review. As a result, the MFDS voted to classify pyridoxine 300mg as a prescription drug with consensus from the committee members.
