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- 2025-12-23 23:21:05
- Policy
- MFDS drug review result to be disclosed within 2 months
- by Lee, Tak-Sun Mar 12, 2021 06:23am
- The pharmaceutical review result for new drug would be disclosed within two months from the completed date. Compared to four months taken at the moment, the information disclosure deadline would be cut by two months. Regardless of the affected company’s request for non-disclosure, the summarized information would be publicly opened to improve the people’s right to know. South Korea’s Ministry of Food and Drug Safety (MFDS) has convened an online seminar on pharmaceutical approval on Mar. 11 and explained the revised regulation. In last December, the ministry drew a guideline up and informed in advance of the information disclosure. Deputy Director Kim Byoung-sam at MFDS Approval Management Team explained, “The ministry has decided to disclose the relevant information due to the heightened social interest on the medical products with the growth in the healthcare industry, and increasing demand for transparency.” Even now, MFDS discloses an item approval review result on its website. The information disclosure scope not only includes new drug, but also the evidence-required drug and generics. However, the information disclosure has been frequently delayed by complicated procedure or even omitted when requested for confidentiality by the applicant company. MFDS is to shorten the time to information disclosure from four months to two months by streamlining the currently two-tracked pre and post-approval procedures into one. Particularly, the information disclosure subject review and report composition taking 60 days and company survey for the disclosure taking 30 days would be dropped. Instead, the ministry would survey the company’s opinion on the information disclosure while the approval review is ongoing, and the information would be posted on the official website after reviewing to opinion. And also the ministry would publish a summarized approval review report from now on, although it used to omit some information requested for confidentiality by the company. Deputy Director Kim elaborated, ”When the confidentiality request is adequate, the result could be undisclosed, but the summarized approval review would be disclosed.” The review summary report would include details on the final approval status, approval condition, incrementally modified drug designation, result of Central Pharmaceutical Affairs Deliberation Committee consultation, preliminary review summary and result, and review history.
- Policy
- 3 drugs including Baricitinib are covered for COVID-19 tx
- by Kim, Jung-Ju Mar 12, 2021 06:22am
- Baricitinib, Corticosteroids, low-molecular weight heparin, and anticoagulants are covered to be used to COVID-19 confirmed patients. Kaletra (Lopinavir + ritonavir), Hydroxychloroquine, and Ribavirin were decided to be removed from the benefit. The MOHW decided to partially revise the notification of details on the application standards and methods of pharmaceutical benefits for drugs in order to properly apply insurance for COVID-19 treatment drugs. and announced on the 11th that it will inquire industry opinions. The main goal of this amendment is to clearly define the target of confirmed patiens with COVID-19 in the COVID-19 treatment (general principle), and the main goal is to clarify the drugs to be covered by reflecting the opinions of the society and recommendations of clinical practice guidelines. Corticosteroids, low molecular weight Heparin and anticoagulants, and Baricitinib are newly added. According to the MOHW, Corticosteroid will be added in accordance with the recommendations for administration of Corticosteroid in severe COVID-19 patients in clinical practice guidelines. LMWH (Low-molecular-weight heparin) and new anticoagulants are recommended to be administered to hospitalized patients as COVID-19 increases the risk of blood clots in the opinions of related society and clinical practice guidelines. In the case of new anticoagulants, it was decided to be covered if the patient's condition is unable to administer low molecular weight heparin. In the case of Baricitinib, considering the fact that Remdesivir & Baricitinib can be administered as an alternative if Remdesivir cannot be administered in the clinical practice guidelines and related opinions of the society, it is planned to be added as a covered drug. Remdesivir decided to be covered when administered concurrently with Baricitinib. Kaletra, Hydroxychloroquine, and Ribavirin were excluded from treatment. The MOHW decided to delete it from the target drug due to the fact that it was not recommended in the clinical practice guidelines and the evidence for clinical usefulness was insufficient. and it is planning to inquire about the revised bill by the 24th and apply it as of April 1st if there are no specific issue, and conduct a review one year after the implementation.
- Policy
- SK-manufactured AZ vaccines for export exceeds domestic use
- by Lee, Tak-Sun Mar 12, 2021 06:22am
- The volume of AstraZeneca COVID-19 vaccine manufactured at SK Bioscience Andong plant for export cleared for lot release has exceeded the volume for domestic supply. The AstraZeneca Korea COVID-19 Vaccine manufactured by SK Bioscience was authorized on Feb. 10, which the National Lot Release cleared 1.57 million doses of it on Feb. 17. Since then, South Korea’s Ministry of Food and Drug Safety (MFDS) has been consistently approving the lot release for the export use. MFDS official reported on Mar. 10, 18 serialized batches were approved for export as of Mar. 9. As each serial number is given on 300,000 doses, basically about 5.4 million doses for export were cleared of lot release. The export volume triples the 1.57 doses approved of the lot release for domestic use. It means more of the domestically manufactured vaccines are supplied to foreign countries than to South Korea, as AstraZeneca is managing the batch distribution. An industry insider elaborated, “Apparently, they have stocked up COVID-19 vaccines manufactured at Andong plant. But because AstraZeneca, as a client for the consignment production, controls all steps from approval to lot release, it cannot be helped.” The exported lots are supplied as COVAX Facility, and recently those batches were designated to nearby Asian countries. Fortunately, South Korea would receive additional batch of AstraZeneca vaccines from COVAX Facility. The government announced AstraZeneca vaccine doses for about 350,000 people would be designated by COVAX Facility within this month and total doses for 1.05 million people, including the doses for 700,000 people in April through May, would be designated to South Korea. Highly likely the batches designated to South Korea would be manufactured by SK Bioscience. But the vaccine maker could speed up the approval process as the batch could be manufactured outside of South Korea. When applying for authorization in last January, AstraZeneca requested the authorization on two items—the vaccines made by SK Bioscience and imported from Italy.
- Policy
- Italy restricts export of AZ vaccine, including Korea
- by Lee, Tak-Sun Mar 11, 2021 06:07am
- It is an analysis that the EU's policy to restrict the export of the COVID-19 vaccine produced in Korea is highly likely to affect Korea. In particular, it is expected that the recent restriction on the export of AstraZeneca vaccine produced in Italy to Australia could directly affect the supply and demand of vaccines in Korea. This is because the AZ imported vaccine, which is currently undergoing approval review, is a product manufactured in Italy. According to foreign media, on the 4th, AstraZeneca requested export to Australia for 250,000 doses of COVID-19 vaccine produced at the Italian factory, but was rejected by EU authorities. The EU has a policy to allow export by examining the quantity requested for export other than the supply within the EU. The Italian-made AstraZeneca vaccine is also highly related to Korea. In January, AstraZeneca applied for a COVID-19 vaccine license, including a vaccine produced by SK Bioscience in Korea and two imported vaccines supplied by an Italian factory. Among them, COVID-19 vaccine produced by SK Bioscience received final approval on February 10, and the imported vaccine produced in Italy is currently under review. Some are raising the possibility of including Italian imported vaccines among the AZ vaccines supplied by COVAX for 1.05 million people that will be introduced from the end of this month to May. Therefore, it is interpreted that prompt product approval is necessary for the smooth supply of imported vaccines. It is known that the MFDS is also in a hurry to permit the AZ vaccine. However, even if permission is obtained prior to supply, it is analyzed that there is little possibility to receive normal supply as the EU restricts exports from overseas. Therefore, it is expected that all of AZ vaccines by Covax must be supplied as a product of SK Bioscience to relieve supply and demand anxiety. It is reported that the government is also in consultation with Covax for this purpose. An official from the government said, "There is a possibility that some imported vaccines will be included in the quantity of AZ vaccines by COVAX, so I know that the government is in consultation with COVAX. However, it is expected that an import license will come out soon, so even if the actual import volume arrives, it is unlikely that it will undergo special import procedures like the case of Pfizer vaccine."
- Policy
- MFDS reviews sales ban on Binex-manufactured generics
- by Lee, Jeong-Hwan Mar 10, 2021 06:27am
- The impact of the allegation on Binex manipulating the manufacturing method and active ingredient dosage in six drugs including antidiabetics and antidepressants is snowballing within the pharmaceutical industry. Source confirmed South Korea’s Ministry of Food and Drug Safety (MFDS) has started reviewing administrative measure to be ordered on generics produced by Binex Busan Plant 1 as a contract manufacturing organization (CMO), which was found to have violated the Pharmaceutical Affairs Act. The ministry has already ordered manufacturing and sales ban on the six products the company decided to voluntarily recall. On Mar. 9, MFDS official explained “The ministry is reviewing the necessity and validity of ordering manufacturing and sales ban or recall on bulk generics manufactured in the same manufacturing plant as six items Binex voluntarily reported of illegal change in manufacturing method. The decision in administrative measure would be officially announced promptly.” The health authority’s action would much complicate the impact the Binex incident has brought onto the South Korean pharmaceutical industry. Four out of six Binex items the ministry imposed the administrative measure were generics manufactured as CMO. CMO generics are drugs by a pharmaceutical company with marketing authorization and another manufacturer with production facility entrusted to manufacture the product. For instance, a pharmaceutical company wins a MFDS marketing authorization on a certain generic, and signs a consignment deal with another pharmaceutical company capable of drug production to manufacture the authorized generic. Basically, the products are made by the CMO, as entrusted by the authorized company, and because the generics made by the both companies are exactly the same, they are labeled as “bulk generics” or “twin drugs.” MFDS is now considering on imposing same level of administrative order as the six items on those bulk generics manufactured at Binex Busan Plant 1 under the consignment deal. On Mar. 7, the ministry imposed administrative measure on six Binex items including antidiabetic Amorin tablet (glimepiride), antidepressant Xelectin capsule and Xelectin 10 mg capsule (fluoxetine hydrochloride), antiarthritic Daxfen tablet (dexibuprofen), anti-inflammatory Rofsin 250 mg tablet (ciprofloxacin hydrochloride) and antihypertension Cadil 1 mg tablet (doxazosin mesylate). And four items—Amorin tablet, Xelectin capsule, Xelectin 10 mg capsule and Rofsin 250 mg tablet—are manufactured by Binex under consignment deals. Three pharmaceutical companies, 13 companies, 15 companies and seven companies have entrusted Binex to manufacture Amorin tablet, Xelectin capsule, Xelectin 10 mg capsule and Rofsin 250 mg tablet, respectively. These are twin drugs manufactured in the same production line at the Binex Busan Plant 1, where generics that accused of fabricating manufacturing method and ingredient dosage and received administrative order were manufactured. As the health authority is considering on ordering sales ban and recall on the bulk generics, the pharmaceutical companies with the products would take a massive hit on their business. MFDS official said, “A related department is currently reviewing the administrative measures on the bulk generics manufactured at Binex Busan Plant 1. The decision has not been made, yet. The on-site inspection at the Busan plant started from Mar. 8. And when the issue is confirmed, the department would make the final decision.”
- Policy
- Sales of 6 BINEX items have been temporarily suspended
- by Lee, Jeong-Hwan Mar 10, 2021 06:27am
- he MFDS decided on the 8th to temporarily suspend the manufacture and sale of six medicines manufactured by BINEX and to collect them. The MFDS is also launching an investigation into a factory located in Busan. Drugs subject to disposal are Amorin (Glimepiride), Xelectin (Fluoxetine), Daxfen (Dexibuprofen), Rofsin 250 mg (Ciprofloxacin), Xelectin 10 mg (Fluoxetine), Cadil 1 mg (Doxazosin). This measure was decided by the MFDS as a precautionary measure against BINEX's submission of a recovery plan for the item manufactured differently from the licensed or reported items to the MFDS, Busan Office. The MFDS policy is to conduct an investigation to confirm the overall manufacturing and quality control of the factory. The MFDS distributes safety bulletins to doctors, pharmacists, and consumers, asking experts such as medical and pharmacists to convert the products to other alternative medicines and cooperate so that product collection can be performed properly. The MOHW and the HIRA also requested restrictions on prescriptions for the product in hospitals and clinics. The MFDS said, "We plan to expedite on-site investigations and necessary measures for BINEX."
- Policy
- Promote disclosure of anticancer drug Expedite Review result
- by Kim, Jung-Ju Mar 09, 2021 06:24am
- A revision of the law is being promoted to revise up the relevant laws and regulations, so-called Fast Track (Expedite Review) for drugs that treat serious diseases, such as anticancer drugs and AIDS drugs, and make the review process transparently disclosed. On the 5th, Rep. Nam In-soon of the Democratic Party of Korea, a member of the National Assembly's Health and Welfare Committee, proposed a partial amendment to the Pharmaceutical Affairs Act on the 5th. The current law stipulates that the Minister of Food and Drug Safety permits the establishment of facilities for the pharmaceutical manufacturing industry or items prescribed by the Prime Minister's Ordinance, and conditional marketing authorization for drugs such as anticancer drugs is stipulated in the subordinate statute. It is necessary to increase the transparency of the review by disclosing the results of review, such as item approval for drugs designated by the ordinance of the Prime Minister, and to improve the accessibility of consumers and companies to review information. This amendment upgrades the conditional permission for drugs such as anticancer drugs to the law, secures procedural justification for conditional marketing authorization, etc. with the opinion of the Central Pharmaceutical Affairs Review Committee, and improves the understanding of the public, while serious diseases, etc. The main goal is to establish a legal basis for the disclosure of review results, such as conditional marketing authorization for medical treatment drugs, designation of priority treatment targets for treatment drugs such as serious and infectious diseases, and item approval. In addition to Rep. Nam In-soon, Rep. Kang Deuk-gu, Kang Seon-woo, Kang Jun-hyun, Kim Min-seok, Kim Young-ho, Park Seong-jun, Park Hong-geun, Yang Jeong-suk, Jung Chun-suk, Joo Chul-hyun, Choi Jong-yoon, Heo Jong-sik, and Hong Seong-guk participated.
- Policy
- Soliris follow-on Ultomiris conditionally listed
- by Lee, Hye-Kyung Mar 09, 2021 06:24am
- Handok’s paroxymal nocturnal hemoglobinuria (PNH) treatment Ultomiris (ravulizumab) is getting closer to the National Health Insurance (NHI) reimbursement. On Mar. 4, the Health Insurance Review and Assessment Service (HIRA) convened a second meeting of the year for the Drug Reimbursement Evaluation Committee (DREC) and deliberated listing six items, such as Ultomiris, Sanofi-Aventis Korea’s Praluent (alirocumab) pen injection 75 mg and 100 mg, Kuhnil, Penmix, Boryung Pharmaceutical and Yungjin Pharm’s Pentosin (daptomycin) injection 350 mg and 500 mg. As a result, the reimbursement for Praluent injection was cleared, but Ultomiris and Pentosin were conditionally passed, where the companies would have to accept a pricing lower than the evaluated price. Ultomiris shares the same active ingredient with one of the most expensive new drugs Soliris (eculizumab). The follow-on drug was authorized by the U.S. Food and Drug Administration (FDA) in December 2018, and European Medicines Agency (EMA) in July 2018. The South Korean health authority approved of the drug on May 21, 2020. The upper limit pricing on Soliris is at 5,132,364 won per vial (30 ml), costing a patient approximately 400 million won a year for administering three vials biweekly. Meanwhile, Ultomiris administers maintenance load once every eight weeks for two weeks after the initial load. The long interval in administration would help lowering the cost per patient even if it is priced similarly to Soliris. However, Handok would win the reimbursement only if it accepts a pricing lower than the DREC’s evaluated price, as it proposed a pricing higher than what DREC evaluated as. All six items containing daptomycin—either approved as domestically manufactured or imported as a complete product of Cubicin authorized in 2003 by an American-based Cubist Pharmaceuticals in 2003—also applied for the listing but received conditional approval.
- Policy
- GC Pharma-Moderna-KCDC ink COVID-19 vaccine contract
- by Lee, Jeong-Hwan Mar 08, 2021 06:20am
- GC Pharma has officially announced it would supply the COVID-19 vaccine developed by Moderna. The decision is made for the vaccine distribution deal signed between the multinational company and the Korea Disease Control and Prevention Agency (KDCA).. On Mar. 4, GC Pharma (President Heo Eun-cheol) stated it would distribute 40 million doses of an American-based Moderna’s COVID-19 vaccine. The company elaborated the decision was made to support the government’s goal by supplying the vaccine at the right timing, immediately after the South Korean authorization procedure. Previously, KDCA said the 40 million doses of Moderna’s COVID-19 vaccine would be imported to the country from the second quarter. The decision was made based on the contracts signed between GC Pharma and Moderna, and GC Pharma and KDCA. The vaccine developer and the health authority would support GC Pharma in processing the local authorization process and take in charge of the local distribution. President Heo Eun-cheol of GC Pharma commented, “We are proud to be able to cooperate with the government and Moderna to supply the vaccine to the people. As controlling the infectious disease is the top priority task for a pharmaceutical company, GC Pharma is seeking various means to prepare for COVID-19 and other prospective public health emergency based on the capability and experience the company has been accumulating.”
- Policy
- Amivantamab designated as a rare drug
- by Lee, Tak-Sun Mar 08, 2021 06:19am
- Janssen's Amivantamab, which is promoting joint development with Yuhan's non-small cell lung cancer treatment Leclaza, has been newly designated as an orphan drug. The MFDS announced that it will newly designate five drugs, including Amivantamab, as orphan drugs, and announce additional target diseases for three drugs, including 5-Aminolevulinic acid HCl. Orphan drugs are used for the purpose of diagnosing or treating rare diseases. It is a drug that has been designated by the Minister of Food and Drug Safety with no alternative drugs or with improved safety or efficacy than alternative drugs. Amivantamab has been designated as a treatment for non-small cell lung cancer with an epidermal growth factor receptor (EGFR) exon 20 insertion mutation. In order to support the development of treatments for rare and incurable diseases, the MFDS is operating an orphan drug designation system that allows rapid approval of orphan drugs according to the characteristics of the disease. An official from the MFDS said, "The designation of an orphan drug is expected to help in the development of treatments for people with rare and intractable diseases." It said, "We will continue to formulate policies to guarantee patient treatment opportunities in the future."
