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- Policy
- NHIS fully inspects 1479 nursing facilities for COVID-19
- by Lee, Hye-Kyung Feb 21, 2020 06:36am
- National Health Insurance Service (NHIS, President Kim Yong Ik) has announced a plan to inspect all 1,479 nursing facilities and long-term care institutes to prevent spreading of COVID-19. From Feb. 17 to 18, NHIS has inspected all nursing facilities related to status of inpatient with pneumonia from unknown cause, staff and nurse with travel history of (visiting China, Hong Kong and Macau) removed from wards, and other compliance regarding COVID-19 prevention. As a follow-up measure of the long-term care institute safety control guideline, the complete inspection would be conducted on 312 institutes with foreign workers, and 754 long-term care institutes with workers who have traveled overseas in February. The long-term care institute inspection would focus on pre-training on related workers and inpatient and preventive rule compliance, management of foreign workers or local workers with travel history, testing and care for inpatient with pneumonia, and visitation control. President Kim Yong Ik stated, “As a preemptive measure to shut off spreading of COVID-19, the agency would fully inspect long-term care institute and nursing facilities to further secure patients’ safety.”
- Policy
- Stivarga renews RSA and Azilect lowers pricing by 30%
- by Kim, Jung-Ju Feb 21, 2020 06:36am
- By renewing an expiring risk sharing agreement (RSA) with National Health Insurance Service (NHIS), Bayer Korea has decided to lower the maximum reimbursed price for metastatic colorectal cancer and gastrointestinal stromal tumor (GIST) treatment Stivarga 40 mg tablet (regorafenib) by 7 percent. And the health regulator has authorized pricing reduction on idiopathic Parkinson’s disease treatment Azilect tablet (rasagiline msylate) by 30 percent. Korea’s Ministry of Health and Welfare (MOHW) plans to reflect the changes on the List of Reimbursed Drugs and Maximum Reimbursed Price. Although most of the changes would come in effect from Mar. 1, some changes would be enforced from different dates due to individual issues. ◆ RSA-renewed drug: Bayer’s Stivarga has successfully renewed soon-to-be expiring RSA with NHIS on the 40 mg tablet, indicated to treat metastatic colorectal cancer, GIST, and hepatocellular carcinoma (HCC). Stivarga 40 mg tablet took the refund type RSA track from June 1, 2016, and received reimbursement in Korea. The original RSA, typically lasting for four years, was expected to expire on coming May 31. The current reimbursed price is at 36,608 won, and the company has agreed to lower it by 7 percent to 34,045 won after renewing the negotiation. The lowered pricing would be applied from June 1, when the renewed agreement comes in effect. Accordingly, Korea now has three RSA-renewed drugs including Stivarga. Merck’s metastatic colorectal cancer treatment Erbitux (cetuximab) and Astellas Pharma’s metastatic prostate cancer treatment Xtandi (enzalutamide) have also renewed their agreements. ◆ Pricing reduction by increased volume: The maximum reimbursed pricea for Betmiga (migabegron) 50 mg and 25 mg tablets would be lowered as they are now subject for Price-volume Agreement (PVA) negotiated with NHIS. The government manages post-marketing pricing with PVA for drugs exceeding initially estimated volume and claimed amount. Under the PVA system, their prices are renegotiated and brought down. The tablet took the Type Na (나) PVA for the negotiation. Type Ga (가) PVA applies to a new drug listed with pricing negotiation, but had claimed volume over 30 percent higher than the estimated volume. For the agreement, the item has to have same company name, administration method, substance, and formulation as when it was first listed. The Type Na PVA, applied to Betmiga, is for new drug either price adjusted by Type Ga or four years passed since listing date, and accumulated claimed volume surpassed the estimation by 30 percent. It also applies when a drug’s accumulated claimed volume in a year is surged by 60 percent from the previous year, or is increased by 10 percent but the increased amount is over 5 billion won. The negotiated pricing each lowered the original prices by 5.9 percent. The maximum prices of 50 mg tablet and 20 mg tablet was dropped from 757 won to 712 won, and from 505 won to 475 won, respectively. .The new pricing would take in effect from Mar .1 .Meanwhile, another drug’s pricing would be lowered early due to expanded indication .Based on analysis of estimated additional claimed volume and the increase rate, Takeda Pharmaceuticals Korea has agreed to reduce the pricing of Adcetris (brentuximab) .Coming in effect from March, the current price of 3,262,400 won would be reduced by 3.6 percent to 3,144,953 won .◆ Government-authorized changes: Due to generic’s reimbursement listing, total ten originals or drugs with same administration method, ingredients and formulation as an original would have their maximum price brought down by the government from Mar .1 .When a first generic is listed for reimbursement, the government applies so-called ‘half-price,’ or 53.55 percent of the original’s price, on the generic .But it applies weighted pricing of 70 percent of the original’s for the first year from the point of listing .And the weighted pricing is sustained, even after a year, when there are less than three companies supplying items in the same class .The pricing is kept until the number of companies reaches over four .The prices of Lundbeck Korea’s Azilect 1 mg tablet and 0.5 mg tablet would fall by 30 percent from 3,501 won and 2,348 won to 2,451 won and 1,643 won, respectively .And the price of Lily Korea’s osteoporosis treatment Forsteo (teriparatide) has also dropped by 30 percent from 326,358 won to 228,451 won .Dong-A ST’s osteoporosis treatment Teribone SC injection 56.5 μg (teriparatide acetate) would be priced 22.2 percent lower from 73,287 to 57,001 won .Except for Forsteo, other drugs’ weighted pricing would be eliminated from next Feb .1 .The ‘half-price’ would be applied from then on .◆ Raised maximum price and voluntarily-reduced drug pricing: Prices of seven items, designated as radiopharmaceuticals, would be significantly raised from Mar .1 to secure consistent supply in Korean market .The government either accepts raised maximum pricing of radiopharmaceuticals and National Essential Drugs, or compensates for the raised pricing by negotiating with NHIS .The price of Korea Atomic Energy Research Institute’s Kaeri MIBG (1311) injection (2-iodobenzyguanidine (1311)) would be raised slight or exponentially by 0.4 percent of 120.6 percent, depending on the dose .Some other items are voluntarily lowering their prices to better compete in the market .The following six items are the case; Dong Kook Pharmaceutical’s antidepressant Dulcerin capsule (duloxetine hydrocholoride) in two doses, Dong Wha Pharm’s severe hand eczema treatment alitno soft capsule (alitretinoin) in two doses, Pharmbio Korea’s chronic pancreatitis quick symptom reliever Foichol 100 mg tablet (camostat mesilate), Hanmi Pharmaceutical’s HIV-1 infection and chronic hepatitis B virus treatment Tefovir tablet (tenofovir disoproxil phosphate) .Dulcerin 30 mg and 60 mg capsules’ would be lowered by 4 percent and 6.7 percent, respectively .Hanmi Pharmaceutical’s Tefovir tablet price would be lowered by 17.5 percent from 2,910 won to 2,400 won .
- Company
- SCD Pharm confirms Eylea's US partner
- by Lee, Seok-Jun Feb 21, 2020 06:35am
- Jeon In-seok, SCD Pharm’s CEO In-seok Jeon, SCD Pharm’s CEO, said on the 18th that he had selected US and European partners for Eylea’s Biosimilar (SCD411). Only Senju Pharmaceutical in Japan contracted SCD411. According to CEO Jeon’s remarks, additional export announcements (disclosures, etc.) are imminent. SCD411 is about to launch its global phase III study in the first half of this year. In addition to SCD411, Jeon said, "We are developing oral diabetes drugs (insulin, GLP-1) and anticancer drugs (Enbrel and Herceptin) as oral drugs". The reason why global pharmaceutical companies are having their eye on SCD411? The CEO mentioned five things about SCD411 competitiveness. Those five things are △ original formulation patents and overseas applications (US, JP, EU, etc.) △2000L CMO production line construction Completed pre-verification regarding IND △development of the same product line as the original △completed pre-validation of IND-related products such as quality, non-clinical, clinical, etc. with each country's permit holders (outside Japan, Europe, and the US) △ development of the same product line as the original. Jeon said, “The meaning of certification and securing the 2000L production facility is that it lowered the risk of quality equality during the scale-up process. The cost competitiveness is more than three times cheaper than 500L, and That's the capacity to cover global demand. Non-clinical studies were conducted with the global CRO Cobans, but some of them were delayed due to Cobans issues. However, the delayed part was replaced with a three-phase preparation process, which minimized time leakage. In particular, he emphasized the same product development sector as the original. The CEO analyzed that the same vials products as Eylea and PFS (Pre-filled Syringe, Pre-filled Syringe) have been developed, 24 weeks long-acting (long-lasting) products are also under development and SCD Pharm is the only company with this lineup. Following Japan, the US and European partners have been confirmed, and Eylea’s Biosimilar of the existing formulations is expected to start sales in U.S.A & Japan in 2023 and Europe in 2024. 'S-Pass Application', Injection → Oral Development 'Hidden Card' CEO Jeon also unveiled their future strategic projects for the first time. The projects are about the non invasive glucose monitor, S-CHECK, oral development of injectable diabetes treatments such as insulin and GLP-1, and No Needle platform Biz development of injectable anticancer drugs such as Enbrel and Herceptin. The CEO explained that S-CHECK proved similar to the blood glucose meter Roche’s Accu-Check. There was no difference between the blood glucose meter and S-CHECK, non invasive glucose monitor. He said that S-CHECK is 100% blood free, no additional calibration, no need to replace sensors and cartridges and will quickly replace the glucose meter market in the future. It also shared the S-Pass platform, which converts injections into oral ones. S-Pass platform is Nano Micelle + Protein Complex and the Advantages are △GI (gastrointestinal + small intestine) absorption (Quick Acting → Quick Onset) △ encapsulation (permeability and absorption increase) ) △digestion inhibition/high bioavailability(cost reduction and price competitiveness) △Avoiding FDA approved excipients and oils(Ease/permit and minimize side effects) △No antacids and surfactants (Minor side effects for long-term chronic patients) A related advantage is the lack of features for companies looking to develop oral injections. SCD Pharm has filed a patent application for S-Pass last August. The CEO Jeon said, "We are developing Diabetes treatment such as insulin and GLP-1 as well as anti-cancer drugs such as Enbrel and Herceptin as oral drugs using the S-Pass platform. After that, it will be the cornerstone of growth of SCD Pharm after Eylea’s Biosimilar".
- Policy
- Generic drug for Lipiodol was approved
- by Lee, Tak-Sun Feb 21, 2020 06:35am
- Guerbet KoreaThe generic drug of Lipiodol, a special contrast agent which was controversial due to a demand for price increase by the seller, received an item license. Lipiodol may not be able to treat patients in the event of a supply disruption, since there have been no drugs of the same composition so far. With the approval of the generic drug, it is expected that the anxiety problem will be solved. The Ministry of Food and Drug Safety approved the Dongkook’s generic for Lipiodol (Iodized oil; ethyl esters of the iodised fatty acids of poppy seed) on 11th. This product was made by Dongkook Pharmaceutical, which has a high market share in the contrast medium market. Similar to Lipiodol, it is used for lymphography, salivary gland imaging and transarterial chemoembolization (TACE) in liver cancer. Lipiodol's supply disruption happened in 2018. At that time, Guerbet Korea, which sells Lipiodol, applied for drug price adjustments that said supply could be stopped if price increases were not premised due to a surge in overseas demand. At that time, the patient groups condemned Guerbet Korea for proceeding with drug price negotiations by taking patients as hostages, and the MFDS reviewed the emergency introduction (import through Korea Orphan & Essential Drug center without permission) in preparation for the supply disruption. In the end, however, the government raised the price of Lipiodol. The drug price was set at ₩190,000/10mL, which was more than three times higher than the previous August (₩52,560/10mL). There was no drug to replace Lipiodol, and It was essential medicine for patients with liver cancer. Yong-ik Kim, chairman of the NHIS, who concluded the drug price negotiations at the time, said, “We set the price at a much lower level than that suggested by the pharmaceutical company. Supply is also expected not to be difficult in the next few years”. Contrary to government evaluations, some criticized the fact that some raised their hands on the domineering of pharmaceutical companies that dominate the market. Lipiodol currently has no patents registered with the MFDS. As such, Dongkuk Pharm has no hurdles in selling generic drugs after the listing.
- Policy
- Hospitals & pharmacies will get COVID-19 benefit early
- by Lee, Jeong-Hwan Feb 20, 2020 10:41pm
- The Minister of Health and Welfare, Neung Hoo Park, noticed the implementation of an early payment within 10 days after the application for the medical expenses paid by hospitals, clinics and pharmacies which were damaged or involved in COVID-19. It will also suspend various investigations and examinations for medical institutions for a certain period of time, and will provide an environment in which it will do its best to protect COVID-19 by exempting the reduction of manpower standards due to the operation of screening clinics. On the 18th, the Minister Neung Hoo Park responded to Sang-hee Kim, a member of the Democratic Party of Korea's inquiry in the COVID-19 Business Report. Sang-hee Kim delivered on-site opinions to the Minister Neung Hoo Park on the 17th at the COVID-19 Expert Meeting with the Chairman of the KMA and the Chairman of KHA. Representative Kim urged the implementation of damage support measures, such as the lack of masks in medical institutions, the exemption system for early payment of medical benefit, postponement of various screening schedules for medical institutions, and the application of exceptions for non-compliance with general medical personnel standards. The Minister Park replied that he would operate the policy to accommodate all aspects. He said that it would be resolved by contracting with a manufacturer that produces 50,000 masks a week so medical staff can receive infection masks first, and early payment of medical benefit is also in progress and will be implemented soon. He also said, "We will also delay the screening schedule for medical institutions or reflect exceptions regarding the reduction of manpower in the standard of medical personnel to screening clinics".
- Company
- Long-waited reimbursed Ibrance+Faslodex in arm’s reach
- by Eo, Yun-Ho Feb 20, 2020 06:42am
- From top, Ibrance, Verzenio and Kisqali After two long years, Pfizer is finally in proximity to win reimbursement on Ibrance plus Faslodex combination therapy. Pharmaceutical industry source reported, Drug Reimbursement Evaluation Committee (DREC), under Health Insurance Review and Assessment Service (HIRA), has cleared the combination therapy consisting of Pfizer’s CDK4/6 inhibiting Ibrance (palbociclib) and AstraZeneca’s Faslodex (fulvestrant). Both companies have each applied for expanded reimbursement last year, in which Ibrance took the risk sharing agreement (RSA) expansion track and Faslodex took the general reimbursement expansion track. Faslodex would need to undergo HIRA’s financial impact review for its general reimbursement status, whereas Ibrance, reimbursed with RSA, would have to negotiate pricing with National Health Insurance Service (NHIS). ◆ Processing health insurance benefit for Ibrance plus Faslodex combination therapy: Although the final decision on the benefit is just around the corner, Pfizer has gone through a lot until now. The needs for the combination therapy was voiced since 2017, when the ‘Ibrance incident’ occurred. In November of the same year, Ibrance was just listed for reimbursement as a first-line treatment, and Faslodex had not been listed, yet, as a monotherapy. In fact, Faslodex has been approved to market in Korea for over a decade. AstraZeneca has struggled to find the middle ground with the health authority over the cost-effectiveness of Faslodex monotherapy. But as the public’s interest on Ibrance combination therapy has heightened, the needs for reimbursed Faslodex also soared. With the increasing needs for it, the combination therapy first applied for reimbursement in the first half of 2018. While AstraZeneca submitted the application without fully processing the Faslodex monotherapy listing, Pfizer submitted the application to expand Ibrance’ reimbursed indication. However, the government requested AstraZeneca to withdraw the application as the monotherapy has not been listed, yet, and rejected Pfizer’s application as its drug was already listed. Since then, AstraZeneza accepted pricing lower than the weighted average price of alterative options to list Faslodex as monotherapy, and finally received reimbursement in last April. When the monotherapy listing was technically finalized in last March, Pfizer immediately applied for reimbursement on the combination therapy and received its long waited reimbursement. ◆ Pfizer letting the competitor join while waiting: Regardless of the fruitful outcome, it also seems somewhat unfair for Pfizer. When the company waited for Faslodex to get listed, other follow-on CDK4/6 inhibitors have been approved and started the listing procedure. And there are two competitors. First is Lilly’s Verzenio (abemaciclib), which has submitted application for reimbursement last May immediately after MFDS’ approval. As CDK4/6 inhibitor plus Faslodex combination had not been listed before, Verzenio was able to apply for RSA-based reimbursement on the specific indication. The second is Novartis’ Kisqali (ribociclib). Unlike the others, Kisqali is indicated as first-line combination therapy with Faslodex, except for female patients before menopause. Approved by MFDS last October, Kisqali has started listing procedure expecting to get the a positive final decision. Following the decision by Cancer Deliberation Committee in last September, Verzenio is waiting for deliberation by DREC. Running behind the others, Kisqali has just passed Cancer Deliberation Committee last month. As a result, CDK4/6 inhibitor plus Faslodex combination therapy would be listed for reimbursement without much of difference among three items. More than anything, their pricing negotiation period may overlap. According to Market Access representative at a multinational pharmaceutical company stated, “The government could enhance negotiation power and lower financial risk when discussing listing of competing drugs at a same time, but as for patients, their waiting time could get longer. Either way, the decision would have to be made carefully.”
- Company
- Jeil·Hanlim’s authorized generics, challenge to the market
- by Nho, Byung Chul Feb 20, 2020 06:42am
- Circadin‘s authorized generics are expected to be released to the market as early as next month. According to the industry, Jeil, Hanlim, and CMG will release their products sequentially in March, April, and May through Kuhnil. The reason for launching Circadin‘s authorized Generics seems to be aimed at the market for the patent expiration scheduled for this June. Once the launch of authorized generics is completed in the first half, more than 10 pharmaceutical companies, including Boryeong, SK Chemicals, Yungjin, and Daewoong Bio, are expected to start pouring out in November. Introduced in the domestic market in July 2014, Kuhnil’s Circadin is a sleep-inducing agent based on Melatonin. Circadin was developed by Neuroim Phamaceuticals, a company specializing in the development of CNS-based senile diseases, and is currently marketed in 43 countries, including the UK, France and Italy.. Domestic copyright is monopolized by Kuhnil and forms ₩7~10 billion units in six years since its launch. The market is expected to expand further if authorized generics and generics are added. Circadin’s authorized generic drugs sold by Jeil, Hanlim, and CMG will be imported from Guhnil and supplied to these pharmaceutical companies. Circadin, licensed as a prescription drug, currently costs ₩1,000 to ₩1200 per tablet. The authurized generics seen by the industry are also expected to be formed at this price range. The generic price is expected to be set at around ₩400 per party. Circadin is the first drug to treat insomnia that restores brain and body function by controlling Melatonin. Melatonin is a hormone secreted by the brain that can cause insomnia if it is not secreted or secreted less. Circadin is the first sustained-release Melatonin released similarly to endogenous melatonin, which not only improves sleep quality but also has lower side effects than conventional drugs. Indeed, domestic clinical trials of insomnia patients over the age of 55 have shown that the quality of sleep, time to sleep, total sleep time, sleep efficiency, and daytime activity after taking Circadin have improved, but no special side effects occur. In addition, existing sleeping pills are limited to 3 to 4 weeks once for psychotropic drugs, whereas Circadin can be prescribed for up to 13 weeks once as a non-psychotropic drug. Existing sleeping pills act on the GABA receptors that suppress the central nervous system, leading to adverse reactions such as daytime lethargy and addictiveness, but Circadin does not act on the GABA receptor and no such adverse event is observed. Melatonin has been widely used as a food since the 1990s, as it has been proved to be effective and safe through long research. However, Melatonin used in foods has a short half-life of 35 to 50 minutes and has a disadvantage in that it does not exhibit sufficient effect. Circadin has been developed to exert its effects throughout sleep by increasing the half-life to about 4 hours with a sustained release technology to release a certain amount for 8-10 hours.
- Company
- Ex-AstraZeneca personnel snatch up top executive positions
- by Lee, Seok-Jun Feb 20, 2020 06:35am
- Former employees of AstraZeneca are favored as top executives in Korean pharmaceutical companies. The positions vary from CEO to vice-president. Korea pharmaceutical companies are aiming to expand overseas business by recruiting former AstraZeneca employees with global experience. AstraZeneca is a British multinational company. Senior Director Namgoong Hyun at GC Pharma At a stockholder’ meeting scheduled on Mar. 25, GC Pharma would discuss of appointing Senior Director Namgoong Hyun (52) as a CEO. The term would last for two years. Senior Director Namgoong has served as a Sales Director and a Marketing Executive for the Asian market at AstraZeneca. GC Pharma newly opened Marketing Department in January, 2018, and recruited her. If the stockholders grant her the position, she would be the first CEO since 1998, when GC Pharma first started filing business reports. Executive VP Pak Sang-jin at Samsung Bioepis Seven years since the establishment, Samsung Bioepis is adopting dual-vice-president system. With the latest personnel changes, head of Commercial Division Pak Sang-jin (50) was promoted as an executive vice-president (VP). Executive VP Pak has also worked at AstraZeneca. Started as a physician, he served as a general manager at GSK Germany and a president at AstraZeneca Korea, before joining Samsung Bioepis in July, 2018. Before Executive VP Pak Sang-jin was appointed, Executive VP Choi Chang Hoon (60, Head of Business Development Division) was the only Executive VP. Daewon Pharmaceutical has also recently recruited Lee Sora, another former AstraZeneca employee, as an executive director of Clinical R&D Division at its Seoul Research Center. Starting her career as a physician, Executive Director Lee Sora used to work at Hanwha Chemical, AbbVie Korea, and AstraZeneca Korea, after serving at MSD Korea, Korean office and Denmark Headquarters of Novo Nordisk. VP Son Ji-woong at LG Chem A couple of former AstraZeneca employees have taken the top commanding position at LG Chem Bioscience Division and Dongwha Pharm. In February 2017, LG Chem appointed VP Son Ji-woong (56) as a head of Bioscience Division. VP Son graduated from Seoul National University College of Medicine, and worked as an internal medicine specialist doctor at Seoul National University Hospital and as a professor at Clinical Immunology Department of Hallym University College of Medicine. His career continued as an Executive VP for Oncology Business Unit in Asia-Pacific Region at AstraZeneca, and a VP and CMO at Hanmi Pharmaceutical. President & CEO Park Kihwan at Dongwha Pharm President and CEO of Dongwha Pharm, Park Kihwan (57), joined the Korean company in last March after working at AstraZeneca. From 2003, Park was appointed as Business Unit Director at AstraZeneca Korea. Park was also appointed as General Manager of Boehringer Ingelheim Korea, Managing Director of China and South East Asia and Managing Director of Korean Office at UCB.
- Policy
- MFDS reveals detailed clinical trial inspection plan
- by Lee, Tak-Sun Feb 20, 2020 06:35am
- Korea’s Ministry of Food and Drug Safety (MFDS) plans to conduct extensive inspection on clinical trial regarding pharmaceutical approval. The subjects are new drugs and drugs required to submit evidential data. Accordingly, pharmaceutical companies, CRO, and healthcare institutes would be investigated by Clinical Trial Management Division of MFDS. But, bioequivalence test covered under Good Clinical Practice (GCP) would be investigated by Pharmaceutical Equivalence Division and MFDS Regional Office as usual. As of Feb. 11, MFDS disclosed ‘Master Plan 2020 for Pharmaceutical Clinical Trial Audit and Inspection’ on its website. The plan specified ‘the authority would inspect clinical trial institute and sponsor (or CRO) to confirm their credibility of clinical trial and its outcome report.’ The plan stated, a sponsor or CRO who have been inspected in last two years would be exempted. And a clinical research institute would be exempted as well, if it has been inspected during a regular audit, or has been inspected more than three times in past one year. The research institute (principal investigator) would be inspected on followings; general details on clinical trial protocol approval and related contract; adequacy of clinical trial documented by principal investigator or research institute; adequacy of information exchange between principal investigator and institutional Review Board (IRB); adequacy of qualification and training of clinical trial related human resources; adequacy of principal investigator leading clinical trial; adequacy of consent by investigated subject; adequacy of recording and reporting data related to efficacy and safety evaluation; adequacy of managing pharmaceuticals used for clinical trial; and adequacy of laboratory information and human sample management. Sponsors (or CRO) would be inspected on followings; general details of clinical trial (schedule by each phase); adequacy of sponsor’s clinical trial document, standard operating procedure (SOP) system, documentation and management; adequacy of sponsor organization and human resources; adequacy of clinical trial development, protocol, and preparation stages; adequacy of sponsor conducting and managing clinical trial (CRO designation and supervising); adequacy of pharmaceutical quality control for clinical trial-use; adequacy of laboratory information and human body sample management (if applicable); adequacy of monitoring work; adequacy of data management; adequacy of analyzing statistics; adequacy of quality control system and audit task; adequacy of adverse reaction assessment system; and adequacy of protocol, final report and other medical writing. Some had expected that the extensive inspection would target all types of clinical trials executed for pharmaceutical approval, including bioequivalence test. But the Clinical Trial Management Division at MFDS confirmed it would only target new drugs and items required to submit documents. Bioequivalence test would not be a part of Clinical Trial Management Division’s inspection. Instead, MFDS Pharmaceutical Equivalence Division and Regional Offices would be in charge of post-management. Bioequivalence test has never been a part of clinical trial inspection. MFDS official explained, “Regular inspection on bioequivalence test has been discontinued, but it is conducted when needed. Healthcare institute, analytic institute and manufacturing company are all applicable for the inspection.” The industry, however, advises pharmaceutical companies, CRO and healthcare institutes running bioequivalence test should prepare for MFDS’ inspection, as it has been managed under Korea Good Clinical Practice (KGCP) from 2017, and the Bioequivalence Test Management Standard has been abolished from last October. An industry insider explained, “For previous bioequivalence test inspection, only the institute analyzing human body sample used be the subject. But as MFDS is tightening the regulation based on KGCP, pharmaceutical companies, CRO, and healthcare institute should also reinforce self-inspection capacity to generally improve clinical trial quality than only focusing on analysis.” The insider specifically suggested, “Small and medium pharmaceutical companies lacking inspection staff should also enhance audit capacity. Entrusting the inspection work to CRO could be a solution.”
- Opinion
- [FOCUS] Distrust caused by pharmaceutical and bio companies
- by Chon, Seung-Hyun Feb 20, 2020 06:34am
- Financial authorities again cut the disclosure of pharmaceutical and bio companies. The Korea Exchange prepared the 'Inclusive Disclosure Guidelines for Pharmaceuticals and Bio-Industry' and recommended that specific disclosure cases be followed and followed in accordance with industry characteristics. The intention is to encourage investors to provide detailed information on important management matters in order to make reasonable investment decisions. In detail, listed companies should disclose the facts and results of their application for a clinical trial plan. Even if a previously approved clinical trial plan has changed, it needs to be disclosed. Even when the trial is suspended or terminated, companies should be informed in detail. The facts and results of companies applying for an authorization for a new drug under development are also included in the important information. The release of a drug with a certain sales volume is also subject to disclosure. This is not the first time financial authorities have proposed disclosure standards for pharmaceutical and bio companies. In 2018, the Financial Supervisory Service inspected the business reports of pharmaceutical and bio companies, and as a result, the disclosure of important information and risks was insufficient. At the time, the Financial Supervisory Service recommended the detailed disclosure of major management contracts and R&D activities. Since then, pharmaceutical and bio companies have begun to disclose the progress of technology transfer projects, R&D personnel, and government subsidies in a unified form. The reason why financial authorities continue to question the disclosure of pharmaceutical and bio companies is investor protection. The company's activities are not being delivered to investors. In fact, suspicions have long been raised that pharmaceutical and bio companies only provide limited information on stock prices. Hundreds of clinical trials are initiated each year with the approval of the Food and Drug Administration. It was hard to find cases of voluntary disclosure of clinical trial discontinuation or failure. Considering the fact that the success rate of new drug development is less than 10%, doubts were raised that pharmaceutical companies conceal unfavorable information on stock prices. Although overseas, many pharmaceutical and bio companies preemptively disclosed unfavorable cases such as clinical discontinuance or abandonment of license application, the atmosphere was quite different in Korea. There was a lot of talk about the issue of ambiguous clinical trial results on bio companies. In many cases, they reported failures in key clinical trials, and then added conditions to confuse investors in a 'virtual success' manner. In introducing the results of clinical trials, there were many cases where unfamiliar words such as 'usefulness' and 'uselessness' were disclosed. The ambiguity was repeated, "The first goal failed, but the second goal was achieved". The article about a meeting with a regulatory officer who is not involved in the success of the trial or marketing authorization can be mistaken as if it were a great success. Even with the results of the same clinical trial, the stocks were fluctuating as the interpretations were mixed. After recording the lower limit, a few days later, it went back to the upper limit, and the jagged steps continued. At this point, I would like to ask what are the goals of drug development. It is the ultimate goal of new drug development to develop and supply innovative medicines to patients. Even with the approval of foreign regulators, we cannot guarantee how much sales will actually occur. Even if they haven't entered the license application step, it's hard to argue success with just one or two indicators. The financial authorities are also introducing the disclosure standard, the success of new drug development is determined by the regulatory agency's marketing authorization based on the results of clinical trials. Financial authorities pointed out that it is not advisable to announce the results of an intermediate trial as a clinical trial success. Unfortunately, Korea has never produced a success story on the global stage yet. In the future, it is likely that there will be more failure cases than probability. Indeed, the fact that financial authorities are providing pharmaceutical and bio companies with detailed disclosure standards and best practices for new drug development is a sign of great distrust. Some companies may complain that the government is trying to intervene in too little detail. However, the distrust of domestic pharmaceutical and bio companies has caused themselves. Developing new drugs with funds from investors is a duty to provide investors with clear information. If it was intended to mislead investors, it should not have been invested in the first place.
