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- 2026-05-03 10:13:36
- Policy
- The aftermath of the COVID-19 Pandemic
- by Lee, Hye-Kyung Feb 03, 2023 05:54am
- There is a need to convert COVID-19 vaccines and treatments, which had been designated for rapid screening, to general screening to cope with the COVID-19 pandemic situation. This is because it is argued that screening personnel should not be wasted due to rapid screening of COVID-19 vaccines and treatments in a situation where the world is concerned about COVID-19. In addition, there are voices that COVID-19 vaccines and treatments should be excluded from the rapid screening in order to focus on the Global Innovation Product Rapid Review Support System (GIFT) prepared by the Ministry of Food and Drug Safety last year. In this regard, an official from the Ministry of Food and Drug Safety said, "The Ministry of Food and Drug Safety is keeping an eye on the COVID-19 pandemic discussion. As it has been taken based on laws to cope with the COVID-19 public health crisis, we will take measures related to the rapid screening process for COVID-19 vaccines and treatments. Since August 31, 2020, the Ministry of Food and Drug Safety has established a rapid screening department and is conducting rapid screening only for innovative products such as life-threatening diseases or treatments for rare and incurable diseases and drugs that respond to public health crises. From September 2020 to July 2022, 23 items were designated for rapid examination of medicines, and 17 items were designated and subject to rapid approval review. According to the items that have been approved, COVID-19 vaccines accounted for the largest number of items with 10, followed by five chemicals, one biopharmaceutical, and one biopharmaceutical. The rapid screening period aims to shorten the general screening period to 75% of the general screening period, and the number of working days required for the rapid screening of the COVID-19 vaccine was short, averaging 26 days. This is because the screening period was shortened by using preliminary reviews in consideration of urgency, and 5 out of 10 COVID-19 vaccines that were approved were pre-reviewed and frequently reviewed in areas such as clinical, non-clinical, and quality. However, while the workload has increased, some say that the structure of drug screening personnel's work should be reorganized due to the rapid screening system of COVID-19 vaccines and treatments in order to properly utilize the GIFT system in the future. An official from the pharmaceutical industry said, "The seriousness of COVID-19 has decreased to the extent that even the obligation to wear indoor masks is lifted," adding, "The Ministry of Food and Drug Safety should also consider ending the rapid screening system for COVID-19 vaccines and treatments." Some say that all permits and screening personnel have been put into a rapid screening of COVID-19 vaccines and treatments, and other tasks have been pushed back by nearly a year, he said. "To solve the problem, we need to think about completing the system that was applied to a crisis." The United States recently declared that it would end the COVID-19 public health emergency from May to November. Subsequently, there is an opinion that Korea will be able to completely lift its obligation to wear a mask in May.
- Policy
- CDDC sets reimb standards for Inrebic Capsule
- by Lee, Tak-Sun Feb 03, 2023 05:54am
- A green light has been turned on for the reimbursement of the myelofibrosis treatment Inrebic Cap. (fedratinib, BMS Pharmaceutical Korea) with the Cancer Disease Deliberation Committee setting reimbursement standards for the drug. Also, the reimbursement standards for the ovarian cancer treatment Zejula Cap (niraparib, Takeda Pharmaceutical) have been extended. The drugs will be approved and listed for reimbursement after passing review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee and drug pricing negotiations with the National Health Insurance Service. HIRA announced that it had held the 1st Cancer Disease Deliberation Committee (CDDC) meeting in 2023 on the 1st and announced it had deliberated as such. Inrebic is indicated as a treatment for enlarged spleen or other symptoms related to ▲ primary myelofibrosis ▲ post-polycythemia vera myelofibrosis, and ▲ post-essential thrombocythaemia myelofibrosis in adult patients that have been previously treated with ruxolitinib. The CDDC determined that setting the salary standard in line with the indication was appropriate. The 1st CDDC deliberation results in 2023 Also, the CDDC determined it appropriate to extend reimbursement and set additional reimbursement standards for Zejula Cap as ‘maintenance monotherapy in adult patients with HRD-positive ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have shown response to first-line platinum-based chemotherapy (partial or complete response).’ On the other hand, no reimbursement standard had been set for the MET exon 14 skipping mutation treatments Tabrecta and Tepmetko. At the same meeting, the CDDC declined Kyowa Kirin Korea’s application to set reimbursement standards for ‘Poteligeo Inj’ to treat adult patients with mycosis fungoides (MF) or Sézary syndrome (SS).
- Policy
- Introduction of online electronic sign-off from February
- by Lee, Tak-Sun Feb 02, 2023 05:48am
- NHIS Pharmaceutical Price Negotiation Introduces Online Electronic Signing from February Simplify operations to shorten the end of negotiations. The online electronic signing method will be introduced in next month's drug price negotiations. It is expected to simplify work and shorten the negotiation period by compensating for the shortcomings of the existing written agreement. The NHIS plans to introduce drugs subject to calculation and adjustment first, and next year, it plans to introduce an electronic signing method to negotiate new drugs and usage. NHIS (Chairman Kang Kyung-tae, hereinafter referred to as the Public Corporation) announced on the 30th that it will sign online electronic contracts for drugs subject to calculation and adjustment starting with drugs ordered by the Ministry of Health and Welfare. Since the electronic signing method is a method of signing in the form of an electronic (PDF file) through an authentication service company, it is evaluated that it has compensated for the shortcomings of the existing written agreement. The NHIS expects that related tasks will be greatly simplified, such as issuing and submitting seal certificates and eliminating the process of sending seal seals and mail in written agreements, which have been repeated every negotiation, and the end of the negotiations will be shortened by at least six days. In order to consider the preparation period of pharmaceutical companies and prevent confusion, the company will first apply it to the existing written agreement method and actively promote it by sending detailed notices to individual pharmaceutical companies and pharmaceutical associations and holding online briefing sessions for pharmaceutical companies. An NHIS official said, "We plan to expand the electronic contract method to new drug and usage negotiations next year and unify the agreement method to electronic signing method in the second half of this year. NHIS will continue to contribute to stabilizing the supply and quality of medicines and protecting public health by actively communicating and cooperating with pharmaceutical companies."
- Policy
- A year after Abilify 1mg was released,
- by Lee, Tak-Sun Feb 02, 2023 05:48am
- Competition is expected to intensify as generic companies gradually for Aripiprazole 1mg used for childhood autism hypersensitivity. The original product of this preparation is Otsuka's Aripiprazole 1mg. The drug was approved on December 3, 2021, and even generics appeared in more than a year. According to the industry on the 31st, 1mg of Aripiprazole from Whanin will be listed at 170 won per tab from the 1st of next month. This is the third time as an Aripiprazole 1 mg preparation. As for generic companies, Repizole was the first to register 1mg of Aripiprazole The first drug listed was the original Aripiprazole 1mg, which was listed at 595 won per tab in March last year. Myungin Repizole 1mg was then listed in November last year, becoming the first generic to enter the market. The upper limit of Myungin and Whanin is the same at 170 per tablet. It is about 71% cheaper than the original. Aripiprazole, which is used for schizophrenia and depression, had various doses such as 2 mg, 5 mg, 10 mg, and 15 mg, but there was no use for 1 mg until the 1 mg product was approved. The demand for 1mg was not small while prescribing first doses or combinations. However, as the 1mg product was approved, a new indication was created. 1 mg was recommended with 2 mg as the recommended initial dose of hypersensitivity related to autism disorder in children (6-17 years old). Previously, Otsuka was also licensed in Japan for 1 mg as an initial dose of childhood autism disorder hypersensitivity. As new products came out like this, generic companies responded quickly. Eight months after the original's salary was registered, a master entered the market, and Hwanin also joined the ranks this time. The two pharmaceutical companies also succeeded in paying 30mg of Aripiprazole, which is not even in the original. Last year, the original Aripiprazole was 31.9 billion won in outpatient prescriptions. Myungin Repizole and Whanin Aripizole are 400 million won and 1.2 billion won, respectively, which are wide apart from the original, but latecomers are expected to gradually increase their market share as they are strengthening sales and marketing activities. Accordingly, the movement of the two CNS-specialized pharmaceutical companies, including Myungin and Whanin which have received the 1mg market, is also expected to become active.
- Policy
- South Korea will maintain its EU whitelist
- by Lee, Hye-Kyung Feb 01, 2023 05:54am
- Korea will continue its status as an exempt country from submitting GMP written confirmation while maintaining its EU whitelist. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 30th that Korea has maintained its status as a registered country in its first regular re-evaluation since it was listed on the EU Whitelist (GMP written confirmation exemption country) for the 7th time in the world in 2019. It is interpreted that maintaining the status of a registered country is once again recognized that the domestic drug manufacturing and quality control standards (GMP), the Ministry of Food and Drug Safety's GMP-related regulatory system, and domestic raw drug manufacturers that comply with it are world-class. South Korean pharmaceutical companies expect to reduce the time required by more than four months by exempting the submission of GMP written confirmation when exporting raw materials to the European Union and to help the domestic pharmaceutical industry grow. As of 2021, EU countries' exports ($468,170,000) accounted for 23.7% of Korea's total exports ($1,971,426,000). EU whitelist refers to a list of countries that are exempt from submitting GMP written confirmations if they are recognized as equivalent to the EU by evaluating the manufacturing and GMP of non-EU countries that want to export raw drugs to Europe. Korea, which was listed in 2019, received regular re-evaluation in December last year as it was evaluated based on 10 areas (78 indicators) and re-evaluation to maintain the listing was conducted every three to five years. "The maintenance of the status of the EU whitelist is internationally and objectively recognized for Korea's regulatory capabilities and industrial excellence," said Oh Yoo-kyung, head of the Ministry of Food and Drug Safety. "Our government will boldly change regulations that hinder domestic companies from entering overseas and competing to global standards." The Ministry of Food and Drug Safety expects that maintaining the status of a registered country will also help the government realize a global central country, and will continue to push for regulatory innovation leading international standards to promote and expand its entry into the global market based on regulatory and quality competitiveness in the domestic pharmaceutical sector.
- Policy
- KMA·MOHW discusses essential healthcare at 1st meeting
- by Lee, Jeong-Hwan Jan 31, 2023 05:59am
- The medical community and the Ministry of Health and Welfare held the first meeting of the Pending Medical Issues Council under the agenda of essential healthcare support measures and reached a mutual consensus. On the 30th, the Korean Medical Association (President: Pil-Soo Lee) and the Ministry of Health and Welfare (Minister: Kyu-Hong Cho) held the first meeting at Conference House Dalgaebi (located in Jung-gu, Seoul) at 4:00 pm. From KMA, Kwang-Rae Lee (President, Incheon Medical Association), Sang-Woon Lee (Vice President, KMA ), Jin-Kyu Park Lee (Vice President, KMA ), and Min-Gu Kang (President, Korean Intern Resident Association) attended the meeting. On the government’s side Hyung-Hoon Lee (Director-General, Bureau of Healthcare Policy at MOHW), Jeon-Kyung Cha (Director, Division of Healthcare Policy at MOHW), Joon Kang (Director, Division of Healthcare Security Innovation), Gang-Sup Lim (Director, Division of Nursing Policy) attended the meeting. The Pending Medical Issues Council was organized for the academic society and the government to discuss major medical issues necessary for promoting public health and developing healthcare in Korea. At the first meeting, the two parties agreed that the objective of operating the consultative body should be to 'strengthen essential healthcare and improve Korea’s medical system'. In addition, the parties agreed to actively discuss various tasks at hand and shared their opinions on how to implement the measures for support that the medical community and MOHW collectively built to support essential healthcare. Also, the KMA and MOHW agreed to continue discussing key tasks that should be implemented to strengthen essential healthcare and local healthcare even after the measures to support essential healthcare are announced. Meanwhile, the second Pending Medical Issues Council is set to be held at 3:00 pm on February 9th.
- Policy
- The legislation of cold chain improvement plan is announced
- by Lee, Hye-Kyung Jan 30, 2023 05:55am
- Following biological agents such as insulin, the cold chain regulations for refrigerated and frozen medicines such as eye drops will be eased. The Ministry of Food and Drug Safety announced today (26th) a revision to the "Prime Ministerial Decree on Safety of Drugs," which includes reasonable improvement in temperature management methods to be observed when transporting refrigerated and frozen drugs, and will receive opinions by March 27. The revision to the Prime Minister's Decree calls for dividing the refrigerated and frozen storage products into the current refrigerated and frozen storage products and the allowed products to be stored at temperatures other than refrigerated and frozen for a certain period of time. Transportation facilities equipped with automatic temperature recording devices should be used for all refrigerated and frozen medicines, but in the future, transportation facility standards will be rationalized for products that are allowed to be stored at temperatures other than refrigerated and frozen for a certain period. Products that are allowed to be stored at temperatures other than refrigeration and freezing for a certain period of time can be installed in transportation facilities instead of automatic temperature recorders if the temperature meets the permitted storage conditions when entering and leaving. The Ministry of Food and Drug Safety strengthened drug distribution safety and management standards in January last year, requiring importers and drug wholesalers to have automatic temperature recorders when transporting drugs (including biological products) that require refrigeration and freezing storage. As complaints have been filed at the site, including biological products such as insulin, non-refrigerated products that can be stored at room temperature are excluded from mandatory applications such as automatic temperature recording devices and automatic calibration records. In order to prevent supply instability due to rising costs for temperature management when transporting refrigerated and frozen medicines, the Ministry of Food and Drug Safety discussed with industries such as KDPA, the Korean Pharmaceutical Association, and pharmaceutical companies to improve the cold chain. Earlier in December last year, it was deliberated by the Active Administration Committee to quickly implement drugs for a stable supply of drugs, and measures to improve the transportation management system for refrigerated and frozen medicines will be implemented first from the pre-announcement of the Prime Minister's Decree. Among refrigerated and frozen medicines, a list of products that may not be refrigerated or frozen for a certain period of time when used can be found on the notification board of the representative website of the Ministry of Food and Drug Safety (www.mfds.go.kr). Opinions on this amendment can be submitted to the Ministry of Food and Drug Safety or the Public Participation Legislative Center by March 27.
- Policy
- Price of Dutasteride has fallen to the 200 won range
- by Lee, Tak-Sun Jan 30, 2023 05:54am
- Original AvodartThe upper limit of Dutasteride products used for prostatic hypertrophy and hair loss has fallen to around 200 won. The effect of cascading drug prices is large, and it is expected to affect the hair loss treatment market. According to industries on the 27th, TELCON RF PHARMACEUTICAL's Durid 0.5mg will be listed at the upper limit of 267 won on the 1st of next month. More than 20 of the same system were applied, 85% of the existing lowest price of the same system (315 won). Dutasteride tablets are evaluated as more convenient formulations than conventional capsule formulations. All 37 currently paid drugs are from domestic pharmaceutical companies. Domestic companies have put forward tablets as a differentiation strategy from Avodart, the original drug containing Dutasteride. Analysts say that it is easier to split and swallow than capsule formulation. As more than 20 are listed at once, the upper limit is gradually falling due to the cascaded drug prices implemented by late pharmaceutical companies since July 2020. The lowest price of 267 won is only 38% of the highest price (709 won). The lowest price for a month on the 30th is 8,010 won, while the highest price is 21,270, a difference of more than 10,000 won. The original Avodart is also 709 won per capsule, the highest price. As such, the falling upper limit of Dutasteride is expected to affect the non-reimbursed hair loss treatment market. This is because low prices are advantageous in the non-reimbursed market. If pharmaceutical companies supply products to nursing institutions in line with the upper limit, hospitals and pharmacies will put a margin based on the upper limit. Therefore, the lower the upper limit, the cheaper the non-reimbursed amount when prescribed for hair loss. Hair loss patients also visit hospitals and clinics that prescribe inexpensive products on purpose, so the lowest price is also helpful for market competition. As a result, it is understood that there are pharmaceutical companies that want to register salaries for competitiveness in the hair loss treatment market even if the upper limit is lowered due to cascaded drug prices. Since Dutasteride drugs are covered by benefits for prostate hypertrophy, most pharmaceutical companies have fewer factors to lower the upper limit. Currently, 28 out of 37 Dutasteride tablets are listed at 709 won, the highest price. It is said that a few pharmaceutical companies deliberately lower the upper limit and sell it as a non-payment for hair loss treatment because supplying it cheaper than the upper limit of the actual transaction price could be lowered. Ten of the same products currently licensed remain non-reimbursed.
- Policy
- Negotiating Erleada's price with the NHIS
- by Lee, Tak-Sun Jan 27, 2023 05:51am
- It has been confirmed that Erleada, Janssen Korea's prostate cancer treatment, is negotiating drug prices with the NHIS. This drug was conditionally passed at the deliberation of the HIRA Drug Benefit Evaluation Committee in December last year. According to industries on the 25th, it is negotiating Erleada's price with the NHIS. Erleada was passed at the 12th meeting of the Drug Benefit Evaluation Committee held in December last year on the condition that if the conditions for presenting the drug evaluation committee were accepted, it would be appropriate for benefit. The move to the stage of drug price negotiations is interpreted as meaning that Janssen Korea accepted the amount suggested by the Pharmaceutical Affairs Evaluation Committee. This drug is a hormone-responsive metastatic prostate cancer treatment and was approved in 2020. The efficacy and effect were approved as a combination therapy with androgen-blocking therapy, a treatment for hormonal-responsive metastatic prostate cancer patients. Phase 3 clinical trials (TITAN study) showed that the risk of imaging progression was reduced by 52% compared to the placebo group when frozen in patients with metastatic castration-sensitive prostate cancer, and the risk of death was reduced by 33% compared to the placebo group. At the time of approval by the U.S. FDA in February 2018, Janssen explained that Erleada would be an alternative option to delay metastasis when treating prostate cancer. Erleada is expected to be the next-generation treatment that connects Zytiga of Janssen and Xtandi of Astellas. If a smooth agreement is reached in the drug price negotiation with the NHIS, it will be applied after reporting to the Health Insurance Policy Review Committee of the Ministry of Health and Welfare. In the case of hormone-responsive metastatic prostate cancer, delaying metastasis is an important treatment goal, so if Erleada succeeds in entering the benefits range, the treatment effect will increase and the cost burden on patients will be greatly reduced.
- Policy
- The copyrights of Valcyte, Alvesco, & Bonviva changed
- by Lee, Tak-Sun Jan 27, 2023 05:50am
- As the domestic owners of major drugs such as Valcyte, Alvesco, and Bonviva changed, they were newly reflected in the salary list. All three items were previously copyrighted by the Korean branch of a global pharmaceutical company, but now domestic pharmaceutical companies are the owners. In the case of Valcyte 440mg, pharmaceutical companies will be changed from February 1st from Roche Korea to Chong Kun Dang. The transfer of permission rights has already been completed. The drug is used to treat CMV retinitis in adult AIDS patients. Roche has been copyrighted and sold in Korea in cooperation with Chong Kun Dang, but Chong Kun Dang will sell exclusively in the future. The global copyright of the drug has already been transferred from Roche to Cheplapharm. Chong Kun Dang acquired exclusive sales rights for Valcyte in Korea through a contract with Cheplapharm in March last year. The two asthma treatment Alvesco inhalants will also be changed from AstraZeneca Korea to SK Chemicals in February. As global copyrights moved, domestic copyrights were finally transferred to SK Chemicals. Along with this drug, SK Chemicals also acquired the domestic copyright of AstraZeneca's Omnaris nasal spray. Bonviva is changed from Handok to Jeil. Cheil Pharmaceutical announced last month that it will exclusively supply osteoporosis treatments Bonviva and Bonviva Plus in Korea. Bonviva was originally copyrighted by Roche Korea but later passed to Jeil via Handok. Currently, global copyright is held by the British pharmaceutical company Pharmanovia. Jeil signed an exclusive domestic sales contract for Pharmania and Bonviva, and began sales and marketing activities for hospitals and clinics. Only Bonviva pharmaceutical companies will be replaced in February, but Bonviva is also expected to revise its salary list soon as the license has been transferred to Jeil. Bonviva Plus is licensed by Alvogen Korea, which developed the drug, and Jeil is in charge of selling it. Drugs that are replaced by pharmaceutical companies this time do not change the upper limit.
