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- 2025-12-22 02:51:36
- 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.
- Policy
- MFDS preannounces temporary narcotics designation of 2 drugs
- by Lee, Hye-Kyung Jan 26, 2023 06:05am
- On January 20th, The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) preannounced the designation of two drugs including ‘Etazene’ that is being misused or abused as a narcotics substitute in Korea and abroad. Etazene is a synthetic opioid that has a similar structure and effect to Etonitazene, which has been designated as a narcotic drug, and is being controlled as a temporary-class narcotics drug in Japan. 6-Monoacetylmorphine, whose temporary narcotics designation expires on March 8th, will be redesignated as a Group 2 temporary narcotics drug. The temporary narcotics designation system is a system that manages and controls certain non-narcotics in the same manner as narcotics within a 3-year period due to concerns of such being misused or abused as an alternative to narcotics and posing risks to public health. Substances designated as temporary narcotics are handled and managed in the same manner as narcotic drugs from the date of the pre-announcement. Therefore, carrying, possessing, using, controlling, exporting, importing, manufacturing, trading, assisting in the trade of, giving, or receiving temporary narcotics will be completely banned, and relevant substances can be seized. Also, anyone who export, import, manufacture, trade, assist in the trade, give or receive Group 1 temporary narcotics after the pre-announcement on the list of temporary narcotics will be punished by imprisonment with labor for an indefinite term or not less than 5 years. Anyone who imports, exports, or manufactures Group 2 temporary narcotics shall be punished by imprisonment with labor for not more than 10 years or by a fine not exceeding KRW 100 million. Those who trade, assist in trade, give or receive Group 2 narcotics shall be punished by imprisonment with labor for not more than 5 years or by a fine not exceeding KRW 50 million. MFDS expressed hopes that the preannouncement will help block the distribution of new illicit drugs in advance and will cooperate with relevant prosecution, police, the Korea Customs Service, and other related agencies, and continue making efforts to protect public health from the harms inflicted by new and illicit narcotic drugs.
- Policy
- Penalties for rebate drugs can be replaced by fines
- by Lee, Jeong-Hwan Jan 20, 2023 06:07am
- Rep. Kim Min-seok A bill will be promoted to replace drug price cuts and suspension of salaries for illegal rebates on drugs with fines. It also includes a clause that further strengthens the penalty standard for effective illegal rebate disposal. The move aims to solve the problem of increasing drug costs for patients who have to continue taking drugs due to administrative measures such as suspension of salary. On the 19th, Rep. Kim Min-seok of the Democratic Party of Korea proposed a partial amendment to the National Health Insurance Act. Under the current law, if drug suppliers such as pharmaceutical companies are found to have provided economic benefits to medical personnel for the purpose of promoting sales, drug prices will be lowered and salaries will be suspended. Kim Min-seok agreed to punish illegal rebates strictly but pointed out the problem of patients being damaged by the suspension of drug benefits and drug price cuts. Kim points out that the burden of drug costs for patients who have to continue to take existing drugs will increase significantly, and the anxiety of eating other drugs will also be borne by the patient, which could infringe on the public's right to health. In particular, Rep. Kim was also concerned that prescribing and selling identical drugs that are more expensive than the insurance price of administrative disposition drugs for suspension of salary will increase drug expenditure, increasing the financial burden of health insurance. In addition, in 2018, the National Assembly revised the law to replace the suspension of salary for rebate drugs before the revision but criticized that the government is still applying the old law. In response, Rep. Kim proposed a bill that could replace the drug price reduction and benefit suspension system for rebate drugs with a penalty sound. Kim said, "We will set a strengthened level of penalty standards to enhance the predictability of administrative disposition and effective sanctions on rebates," adding, "We will also solve the problem of patient drug options and accessibility violations due to suspension of drug subsidies."
- Policy
- Rinvoq PR 30 mg & Fexuclu 10 mg listed
- by Lee, Jeong-Hwan Jan 20, 2023 06:07am
- The Ministry of Health and Welfare will overhaul Rinvoq, Procoralan, and Fexuclu (from left) standardsWith the new listing of high-content products of Rinvoq PR, a severe atopic drug, the salary standard changes. The angina drug Procoralan is a standard treatment drug and an angiotensin II receptor blocker is added. Fexuclu, a gastroesophageal reflux disease drug, will have four new benefits listed, including a low content of 10 mg oral medicine. On the 18th, the Ministry of Health and Welfare will collect opinions by the 27th after giving an administrative notice of "partial revision of the detailed (drug) on the application standards and methods of medical care benefits." The scheduled effective date is February 1. ◆ Rinvoq PR 30mg will be newly registered, adding '30mg' to the name of the notification. Considering that the permission matters for each drug are different, the phrase is changed to "dose within the scope of permission for each drug." Currently listed 15 mg has secured indications of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, and ulcerative colitis. The newly listed 30 mg can only be used for atopic dermatitis and ulcerative colitis indications. ◆ Ivabradine= Ministry of Health and Welfare clarifies Procoralan as standard treatment drugs by referring to the Ministry of Food and Drug Safety's permits, guidelines, clinical papers, and expert opinions. Currently, the standard treatment drugs for oral drugs composed of Ivabradin are beta-blockers, ACE inhibitors, and aldosterone antagonists. The Ministry of Health and Welfare will add an angiotensin II receptor blocker to this. ◆Fexuclu=Procoralan, a treatment for improving gastric mucosal lesions of acute gastritis and chronic gastritis, will have a revised salary standard as 10mg is set to be newly registered. Specifically, the phrase "medical care benefits are recognized when administered within the scope of permits (treatment of erosive gastroesophageal reflux disease)" is changed to "medical benefits are recognized within the scope of each drug, and the patient pays the full price except for this recognition." The criterion refers to the treatment of erosive gastroesophageal reflux disease. In the case of "improvement of gastric mucosal lesions of acute gastritis and chronic gastritis", which is an additional permit from the Ministry of Food and Drug Safety, the entire amount is recognized at the expense of the person. As a result, the scope of benefit according to the content of Fexuprazan has become clear. Fexuprazan 40mg, which was listed in July last year, was approved to be used to treat erosive gastroesophageal reflux disease. Salary is recognized at the time of administration. The 10 mg product, which will be listed in February this year, has added indications of "improvement of gastric mucosal lesions of acute gastritis and chronic gastritis." When administered with the indication, the burden is recognized, not the benefit.
- Policy
- Grace period for foreign API mfg site registrations ends
- by Lee, Hye-Kyung Jan 19, 2023 05:58am
- Starting on the 21st, the foreign manufacturing site for all pharmaceuticals (including APIs) imported to Korea from abroad must be registered in advance. The Ministry of Food and Drug Safety announced that the grace period that had been granted in consideration of the industry’s state of preparations in registering foreign manufacturing sites for APIs imported to manufacture of finished products, will end as of January 20th. The mandatory registration of overseas manufacturing sites for all pharmaceuticals went into effect on July 21st last year after the amendment of the Pharmaceutical Affairs Act on July 20th, but a grace period on its immediate implementation was granted until January 20th. Therefore, from January 21st, companies not only would need to register the foreign manufacturing sites for their imported finished drugs and Drug Master File (DMF) drugs but would also need to register the foreign manufacturing sites for imported APIs that the companies use to manufacture their own finished products. The MFDS urged the companies to thoroughly make preparations in advance to prevent disruptions in domestic drug supply and production. The foreign manufacturing site registration system, which took effect in December 2019, was designed to promptly respond to relevant imported drugs in the event risk is identified overseas and mandates the registration of the workforce, facility, and GMP status of the overseas manufacturing site. Information on the overseas manufacturing site is systematically registered, updated, and managed for the latest information, and is used for risk assessment of overseas manufacturing sites and selection of sites subject to on-site inspection. The number of registered overseas manufacturing sites has been steadily increasing, from 1882 sites in 2020 to 2208 sites in 2021, then 2531 sites in 2022. The MFDS said, “We expect the overseas manufacturing site registration system to increase reliability in the quality of imported drugs and contribute to the more thorough and safe management of the drugs. We will continue our efforts to manage the safety of imported drugs to allow our people the safe use of high-quality drugs.”
