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- 2026-04-10 23:49:13
- InterView
- “Novartis will lead the provision of innovative medicines”
- by Eo, Yun-Ho Jan 25, 2023 06:08am
- Byungjae Yoo, General Manager of Novartis Korea The Korean subsidiary of Novartis underwent a period of turmoil last year. The company integrated its Pharmaceuticals and Oncology business units in line with the reorganization policy set by its global headquarters. Before then, the company had been operating 2 separate business units independently under one name. The two units had separate support departments including marketing·sales departments as well as drug pricing·government relations·approval departments. Through the integration process, all of these departments were merged into single departments with one head. As a result, layoffs were made and the head of the integrated subsidiary was appointed for the first time since the company’s establishment. The fact that a Korean representative was appointed to head this first-ever integrated Novartis Korea was also a big change. Since its establishment in 1997 and the first president Frans Hompe, the company had mostly appointed foreign heads to lead the Korean subsidiary, including Jean-Luc Scalabre in 1998, Peter Maag in 2003, Andrin Oswald in 2006, Peter Jager in 2008, Brian Galdsden in 2014, and most recently, Joshi Venugopal. The only Korean national that had been appointed until now was Hak-sun Moon in 2015. Dailypharm met with Byungjae Yoo, General Manager of Novartis Korea, who first-handly lead the company through this momentous change. - You were appointed General Manager of Novartis Korea’s Pharmaceutical division in 2021, and then the General Manager of the integrated Novartis Korea last year. What have you been focusing on in the company amid the various changes that had been made last year? My prime focus was on finding the role and direction for Novartis Korea in the changing global pharmaceutical industry. For this, I reviewed much research and consulting reports on the global pharmaceutical industry over the past year. Also, I discussed Novartis’s strategic priorities and Korea's role with our global head office and region managers. Secondly, I tried to connect with our employees and find out what the employees wanted and how to satisfy such desires. After various discussions, I came to the conclusion that Novartis Korea as a company excelled in being ‘goal-oriented,’ but needed to make more effort in being ’purpose-driven.’ Ultimately, I want Novartis Korea to become a purpose-driven company rather than a goal-oriented company. -The Pharmaceuticals and Oncology business units were integrated last year. What was the purpose of the integration and what is your future direction? The biggest purpose of integrating the business units was to ‘do what we do best.’ As so many companies exist in the pharmaceutical industry, each company needs to find its areas of specialty, such as generic drugs or specialty drugs. Also, the needs of each society or patient are also different. Therefore, Novartis decided to integrate its business units to do what it does best – ‘ to overcome diseases’ – and focus on its 5 core therapeutic areas (cardiovascular, immunology, neuroscience, solid tumors, and hematology) to bring synergistic effects. -What is Novartis Korea’s business goal for this year? From 2018 to 2022, Novartis has had one of the most extensive and innovative pipelines among global pharmaceutical companies. Therefore, the company’s priority this year is to increase patient access to its innovative treatments. We plan to discuss how to increase patient access to such innovative treatments within the limited National Health Insurance budget with experts and reach a social consensus on the measures derived. Also, we plan to continue working with domestic companies and startups. We plan to actively support Korean companies that wish to enter the global market through discussions with our head office. -When setting the 1-year business plan, what products have you set as a priority? Among the newly launched products, therapies that are not yet sufficiently supplied to patients in need will likely be given priority. These include Entresto, Cosentyx, Kisqali, Scemblix, Zolgensma, and Kymriah. -The company received much attention, both good and bad, for successfully listing ultra-high-priced drugs such as Zolgensma, and Kymriah for reimbursement in Korea last year. I heard you have other formidable new drugs awaiting release in your pipeline. Could you share your plans for the future? Novartis is not afraid to take risks in developing new drugs for incurable diseases. This is why the company has a higher probability of developing new drugs as well as a high R&D cost. therefore, we will also need to make efforts to reduce such costs while developing new drugs. Patients talk of how a ray of hope shone through in their desperate situation with the introduction of a new drug. I think access to innovative treatments that address existing unmet needs has been strengthened in general in Korea. However, a lot of discussions are still needed on how to address the resulting increase in social cost. The issue cannot be resolved by just strengthening one part while sacrificing others. Therefore, I plan to continue discussions with relevant parties to devise measures that fit the situation. -Do you have plans in place to improve access to ultra-high-priced drugs in Korea? I think making dialogues will be the answer to finding ways to improve treatment access to such drugs. In the past, when Korea’s health expenditure amount of the total GDP had not been as high as other advanced countries and NHI finances were not in deficit, the patient's medical needs were a decisive factor in determining reimbursement. However, that time has passed, and much discussion is now required for any reimbursement. If experts provide opinions on how to finance the national health insurance and the pros and cons, including whether to finance the NHI through funds, private insurance, or bring in other sources of finances other than the NHI, we could provide opinions from the pharmaceutical company’s perspective and seek out solutions together.
- Pfizer reattempts reimb for its new AML drug Mylotarg
- by Eo, Yun-Ho Jan 20, 2023 06:07am
- A new drug for acute myeloid leukemia (AML), ‘Mylotarg,’ is again attempting reimbursement in Korea. According to industry sources, Pfizer Korea has recently resubmitted its application to reimburse its AML drug Mylotarg (gemtuzumab ozogamicin) in Korea. Mylotarg was deliberated by the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee in May last year but was unable to pass review or set reimbursement standards. Therefore, whether Mylotarg will be able to pass CDDC this time and start its journey to receive reimbursement in Korea remains to be seen. The drug is an antibody-drug conjugate (ADC) approved as a first-line treatment for patients with newly-diagnosed CD33-positive AML. The drug, which received marketing authorization in Korea in December 2021, is an ADC composed of a CD33-targeting monoclonal antibody linked to calicheamicin, a potent cytotoxic agent. The drug works on cells that express the CD33 antigen, which is expressed in more than 90% of AML patients. This blocks cancer cell growth and induces apoptosis. Mylotarg’s approval was based on a clinical trial (ALFA-0701) that was conducted on 271 patients aged between 50 to 70 with newly-diagnosed AML with no prior treatment experience. The ALFA-0701 trial was an open-label, randomly assigned, multicenter Phase III study that compared the existing standard front-line chemotherapy - daunorubicin+cytarabine combination therapy - with Mylotarg+ daunorubicin+cytarabine combination therapy. Results showed that the median event-free survival (EFS) in the Mylotarg+daunorubicin+cytarabine combination therapy group was 17.3 months, which was a 7.8-month extension compared to the 9.5 months in the daunorubicin+cytarabine combination therapy group. Also, the Mylotarg combination therapy reduced the risk of induction failure, relapse, or death by 44% compared to chemotherapy alone. The median relapse-free survival (RFS) was 28.0 months in the Mylotarg+daunorubicin+cytarabine combination therapy group and 11.4 months in the daunorubicin+cytarabine combination therapy group, showing a significant 16.6-month difference with the addition of Mylotarg. In the case of median overall survival (OS), the median OS was 27.5 months in the Mylotarg+daunorubicin+cytarabine combination therapy group and 21.8 months in the daunorubicin+cytarabine combination therapy group, but there was no statistically significant difference between treatment arms in OS. Meanwhile, Mylotarg has passed the drug committees of the Big 5 tertiary hospitals in Korea including the Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary’s hospital, Sinchon Severance hospital, as well as other various medical institutions including the National Cancer Center and Chonnam National University Hwasun Hospital, etc.
- 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."
- Company
- LG Chem completes acquisition of US bio-company AVEO
- by Kim, Jin-Gu Jan 20, 2023 06:07am
- Executives and employees including LG Chem Vice Chairman Hak Cheol Shin (first row, fourth from the left), AVEO CEO Michael Bailey (next to VC Shin), LG Chem Life Sciences President Jeewoong Son (first row, far left) met to take a celebratory photo LG Chem has completed the acquisition of the US bio-company AVEO Pharmaceuticals and plans to make the leap to become one of the 'global top 30 pharmaceutical companies focusing on the oncology business. On the 19th, LG Chem announced that it had invested KRW 707.2 billion (USD 571 million) in its U.S. affiliate, ‘LG Chem Life Science Innovation Center,’ to acquire AVEO Pharmaceuticals on the 18th. The company plans to complete the M&A process by the 20th. LG Chem received approval for the HSR filing on December 1, 2022. Afterward, the merger passed the shareholders’ meeting and was approved by the Committee on Foreign Investment in the United States (CFIUS) on the 17th. After the acquisition, AVEO will be integrated as a subsidiary of LG Chem. However, the company will be operated independently as before based on its oncology business capabilities. AVEO Pharmaceuticals, which was established in Boston, MA in 2002, owns full capabilities ranging from clinical development, approval, sales to marketing in oncology. The company received FDA approval for its targeted therapy Fotivda for the treatment of renal cell carcinoma in 2021. In only 2 years since the release of the new drug, the company raised KRW 130 billion last year, and sales are expected to grow over 60% and achieve KRW 210 billion this year. The US securities companies expect sales of Fotivda to reach KRW 450 billion by 2027. Through the acquisition, LG Chem aspires to grow as a global pharmaceutical company in the field of oncology. In the mid-to-long term, the company will transfer the company’s new anticancer drug pipeline to AVEO and accelerate the commercialization of new oncology drugs in the US. LG Chem is currently developing cell therapies and immune checkpoint inhibitors in the preclinical stage. With the merger, the Life Science Innovation Center, which owns strengths in early-stage research and manufacturing process development, will be in charge of ▲discovering promising anticancer candidate substances, ▲preclinical and early-stage clinical trials, and the ▲commercialization process development, and AVEO, which owns know-how in clinical development and sales in the US market, will be in charge of ▲later stage research of the company’s oncology pipeline, and ▲commercialization. In addition, the company plans to continue reinforcing its anticancer product portfolio by promoting the introduction of oncology tasks in late-stage clinical trials near commercialization. LG Chem plans to invest KRW 2 trillion in its bio-business by 2027 and release 4 or more new drugs in the fields of oncology and metabolic diseases in the global market by 2030. Also, the company plans to achieve sales of KRW 2 trillion by 2027 by expanding sales in existing businesses such as diabetes, vaccines, growth hormones, and oncology. After sales of new drugs currently under development begin in earnest in 2030, LG Chem expects sales to continue to grow by hundreds of billions of won each year. Hak Cheol Shin, Vice Chairman & Chief Executive Officer at LG Chem, said, “We will focus on fostering Aveo as a future bio hub that can drive the growth of our oncology business and combine and maximize synergies of our business to make the leap forward and become one of the 'global top 30 pharmaceutical companies focusing on the oncology business.’ Michael Bailey, CEO of AVEO, said, “The merger has brought AVEO one step closer to its vision of ‘improving the lives of cancer patients.’ By combining the capabilities of the two companies, we will grow to another level and become a company that continues to release new drugs
- Company
- Anti-depressant Brintellix generic for exclusivity succeeded
- by Jan 20, 2023 06:07am
- Myungin Pharmaceutical (CEO Lee Dong-myung) and Unimmed Pharmaceutical (CEO Kim Gun-nam) announced on the 18th that they succeeded in invalidating the patent for the antidepressant Brintellix. The Korean Intellectual Property Tribunal recently made a decision to cite the claim on Brintellix purpose patents filed by both companies against Lundbeck Korea. Lundbeck Korea has a total of two material patents that expire in May 2027 and usage patents that expire in November 2028 related patents that expire in November 2028. Myeongin Pharmaceutical and UniMed Pharmaceutical have filed invalid and passive claims for patents for use. The decision also outlined generic for exclusivity for Brintellix's generics. Myungin Pharmaceutical and Unimed met the requirements for "first trial request" and "first item permit application" by filing a series of requests for judgment in March last year. In June, the Ministry of Food and Drug Safety applied for the first simultaneous generic item license. As both companies win the patent invalidation trial, only the two pharmaceutical companies are expected to acquire generic for exclusivity use of Brintelix. Brintellix was approved domestically in August 2014 as a multi-acting antidepressant through direct regulation of serotonin receptors involved in depression and inhibition of serotonin reabsorption. According to IQVIA, a pharmaceutical market research firm, Brintelix's annual sales continued to grow by double digits every year to 8.7 billion won in 2020, 9.7 billion won in 2021, and 10.4 billion won in 2022. Myungin Pharmaceutical and Unimed Pharmaceutical will be able to sell generic products exclusively for nine months after May 10, 2027, when the substance patent expires.
- 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.
- Company
- The Brain disease prescription market disappears
- by Chon, Seung-Hyun Jan 19, 2023 05:59am
- Pharmaceutical companies lost 30 billion won a year due to Oxiracetam. Prescription loss became a reality as it failed to prove its efficacy in an eight-year clinical re-evaluation. Following acetyl-L-Carnitin last year, the annual prescription market worth 100 billion won has disappeared due to the failure of clinical re-evaluation of cerebrovascular-related drugs over the past year. According to the Ministry of Food and Drug Safety on the 18th, prescription and preparation were suspended because Oxiracetam failed to prove the effectiveness of "improving symptoms of vascular cognitive impairment" as a result of clinical trial reevaluation. Oxiracetam has been licensed to improve cognitive impairment due to Alzheimer's type dementia, multiple infarction dementia, and organic brain syndrome caused by brain failure. Cognitive disorders include decreased memory, attention, and concentration, speech and behavioral disorders, emotional anxiety, and lack of motivation. The Ministry of Food and Drug Safety announced the clinical re-evaluation of Oxiracetam in March 2015. According to the clinical revaluation design, indications were adjusted in 2019 due to the improvement of vascular cognitive impairment. Oxiracetam's deadline for submitting clinical re-evaluation data was set in March 2019, but the deadline for submitting the data was extended twice and finally closed in June last year. As a result of reviewing the clinical trial data, it was concluded that it failed to prove its efficacy, and decided to discontinue the prescription. As a result, Oxiracetam is expected to lead to the deletion of indications and exit from the market eight years after the announcement of clinical re-evaluation. According to UBIST, a drug research agency, the number of outpatient prescriptions for Oxiracetam last year was 21.3 billion won. Oxiracetam formed a prescription market of 30.8 billion won and 31 billion won in 2017 and 2018, respectively. Since the adjustment of indications in 2019, the prescription volume in 2020 has decreased by 26.6% from two years ago to 22.6 billion won, and the decline has continued in 2021 and last year. According to the prescription amount by item, Korea Pharmaceutical's Neuromed showed the largest prescription performance of KRW 11.8 billion last year. This clinical re-evaluation means that Korea Pharmaceutical will lose 11.8 billion won annually. Samjin Pharmaceutical's Neuracetam recorded 5.1 billion won in prescriptions last year, while Hwanin Pharmaceutical's Neuoxitam and Kwangdong Pharmaceutical's Neuropia raised 2.8 billion won and 1.5 billion won, respectively. As a result, drugs related to brain diseases will be removed from the market for the second consecutive year following acetyl-L-Carnitin last year due to failed clinical re-evaluation. Dong-A ST's Nicetile, acetyl-L-Carnitin, has been approved for use in "primary degenerative disease" or "secondary degenerative disease caused by cerebrovascular disease." In 2013, the Ministry of Food and Drug Safety ordered a clinical re-evaluation of acetyl-L-carnitine drugs. The re-evaluation clinical trial was conducted in two groups according to indication. Dong-A ST took the lead in conducting a clinical trial of "primary degenerative disease." Hanmi Pharmaceutical was in charge of clinical trials of "secondary degenerative diseases caused by cerebrovascular disease." As a result of clinical trials, the indication was deleted in July 2019 because it failed to prove the primary degenerative disease. In August last year, it was concluded that the "secondary degenerative disease caused by cerebrovascular disease" also failed to prove its effectiveness. In other words, as a result of nine years of clinical re-evaluation, all indications were not proven, leading to the exit procedure. Acetyl-L-carnitine preparations also suffered from clinical design. It is known that it took about two to three years to set up a clinical design while designing a new clinical trial reflecting the latest scientific standards. At the request of the pharmaceutical company, the deadline for clinical re-evaluation of primary degenerative diseases was extended by two years, and the submission of clinical trial data for secondary degenerative diseases was extended by four years, which resulted in failure. Acetyl-L-Carnitin drugs formed an outpatient prescription scale of 72.6 billion won in 2017 and 74.8 billion won in 2018, but fell to 64 billion won and 51.1 billion won in 2019 and 2020, respectively. With the deletion of the first indication, the market size has been reduced. Last year, the prescription record was 31.6 billion won, but it finally disappeared from the market. As of last year, Hanmi Pharmaceutical's Carnitil left 11 billion won and Dong-A ST's Nicetile left 5 billion won in prescriptions. In 2017 and 2018, Oxiracetam and acetyl-L-Carnitin collaborated on a total of 103.4 billion won and 105.9 billion won in prescriptions. The pharmaceutical industry has become inevitable to lose about 100 billion won a year due to the failure of clinical re-evaluation of oxiracetam and acetyl-L-carnitine drugs.
- Company
- Generic drugs occupy 41% of antidiabetics market in 9 mths
- by Kim, Jin-Gu Jan 19, 2023 05:58am
- Generic products of off-patent drugs are quickly increasing their influence In the DPP-4 inhibitor class antidiabetic drug market. The market share held by generic versions of the original Galvus (vildagliptin) that were launched after the patent expiry of the original drug in March last year increased to 41% at the end of last year. The market share held by generic versions of Tenelia (teneligliptin), which 37 companies jumped in to manufacture, increased to 32% only two months after its release. ◆Market share of Galvus generics increase to 41%...Kyongbo and Hanmi shows greatest advances According to the market research institution UBIST on the 19th, the total outpatient prescriptions for antidiabetic drugs that contain vildagliptin amounted to KRW 46.9 billion last year. Compared to the KRW 46.6 billion made in 2021, the market size itself remained largely unchanged from the previous year. However, when dividing the drugs into original vs. generic drugs, the prescription amount of the originals - Galuvs and Galvusmet - fell 30% in one year and was replaced by generic products. The combined prescription amount of Galuvs and Galvusmet fell 30% last year to record KRW 32.4 billion from the KRW 46.6 billion it had recorded in 2021. When considering how the drug price was reduced by 29.9% with the release of the generic, the prescription volume itself is expected to have remained similar to the previous year. In the market, generic drugs recorded combined prescriptions of KRW 14.5 billion last year. Galvus generics have been continuously increasing its influence in the market ever since its launch in January last year. Since recording KRW 1.1 billion in Q1 last year, sales increased to KRW 3.4 billion in Q2 last year, then to KRW 4.8 billion in Q3 last year, and KRW 5.2 billion in Q4 last year. In the vildagliptin-containing antidiabetics market, the share held by generics increased to 41% as of December last year. The market share of generic drugs increased rapidly until September last year, then remained in the early 40% range ever since. Last year, 15 domestic companies released Galvus generics. Among the generic companies, Kyongbo Pharmaceutical and Hanmi Pharmaceutical recorded the highest prescription performance. The combined prescription amount of the two products amounts to KRW 6.3 billion. The amount was followed by Hanmi Pharmaceuticals’ Vildagle and Vildaglemet which made KRW 3.9 billion, then by Angook Pharmaceutical’s Avus and Avusmet which made KRW 2.6 billion. The other generic companies made annual outpatient prescriptions that amounted to less than KRW 1 billion each. ◆ Tenelia generics’ market share surged to 32% only 2 months after release Tenelia generics are also rapidly increasing their influence in the market 37 domestic companies released Tenelia generics after its patent expired on October 25 last year. Since then, the companies recorded KRW 2.9 billion in prescriptions in two months. As of last year, the share of teneligliptin-containing drugs in the diabetes treatment market expanded to 32% as of December last year. However, the increased prescriptions for generics did not lead to a decrease in prescriptions for the original products. Rather, the prescription amount of Handok’s Tenelia and Tenelia M, the original products, increased slightly from KRW 47.7 billion in 2021 to KRW 48 billion last year. This is because the drug price of the original product has not been lowered despite the generic’s release. The generic companies developed products using salts that are different from the original, which allowed the original drug to maintain its previous price. No single product recorded remarkable performance among Tenelia generics. All 37 companies are recording prescriptions ranging around KRW 100 million. A pharmaceutical industry official said, “Fierce sales competition is ongoing between generic companies to secure a market share in the earlier stages of the generic release. We expect this competition to continue until the patent for another DPP-4 inhibitor, Januvia, expires in September this year."
- 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.”
- Product
- Viatris Korea, "Viagra's supply expected on Jan 23"
- by Kim JiEun Jan 19, 2023 05:58am
- Viatris Korea announced short-term out-of-stock for some products, including Viagra, while predicting normal supply this month. On the 16th, Viatris Korea sent a notice to hospitals, pharmacies, and drug wholesalers on the 16th, saying, "Viagra, Viagra Film, Cardura-XL, Detrusitol Short-Term Out of Stock." In the announcement, the company said, "Based on the currently available information, we mainly expect the time when normal supply is possible on January 23, 2023." He added, "We deeply apologize for the inconvenience caused to medical treatment or work due to this short-term out-of-stock," adding, "We will continue to do our best for a stable supply." The items subject to the announcement have been out of stock not only at online malls for drugs but also at wholesalers since the end of the sales rights of Jeil Pharmaceuticals at the end of last year. The industry expected Menarini Korea to take over the next batch of sales rights for these items, but negotiations with Viatris Korea have not been completed so far.
