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- 2026-05-20 18:53:30
- Policy
- It is time to support quarantine with the 'COVID-19'
- by Lee, Jeong-Hwan Feb 14, 2020 06:35am
- The Democratic Party's COVID-19 Countermeasures Committee urged an agreement on the opposition party on the composition of parliament. With the intention that the national disaster should not be controversial due to naming conflicts such as Wuhan pneumonia, it is a suggestion that the government should support joint efforts on the prevention site by creating a joint special led by the Health and Welfare Committee by establishing a joint specialty centering on the new corona name 'COVID-19' finalized by the WHO. On the 12th, the Democratic Party's COVID-19 Countermeasures Committee (Chairman Sang-hee Kim) began hearing opinions on the site of defense at the Democratic Party's representative office in the National Assembly. On this day, Kyung Rim Shin, the chairman of the Korean nurses association, Senior Vice Chairman No-bong Park, the Korean health and Medical Workers’ Union, Senior Vice Chairman No-Bong Park of the National Health Care Industry, Senior Vice Chairman Mi-Kyung Kwon of the Federation of Korea Medical industry Trade Union(KMITU), Chairman Mok Huh, National public health center’s director council and Chairman Jung-Hyun Cho of the Korean Public Health Council. If the last meeting was to collect voices of macroscopic defense sites from the heads of doctors' associations and hospital associations, this time, The intention is to look into more detailed microprotective situations. Chairman Sang-hee Kim stressed the need for COVID-19 in the parliament. The WHO named the new corona official name as COVID-19 and the Ministry of Health and Welfare followed the domestic name as Corona-19, suggesting that the background for the rapid creation of undisputed privileges was provided. Chairman Kim said, "The WHO has set the official name of the new corona as COVID-19. So far, unnecessary controversy over the congressional narrative over the National Assembly Corona has been continued, this is deplorable. It would be reasonable to focus on welfare. The name is subsidiary and it is productive to support the defense by creating a parliamentary commission. It would be reasonable to focus on the welfare committee " Chairman Kim said, "The government is currently taking measures to deal with the serious stages of the prime minister. The patient is discharged, but there is no situation to be relieved yet, and we will try to provide enough budget to small businesses". Kyung Rim Shin, the chairman of the Korean nurses association asked the medical staff such as nurses who are involved in the quarantine service not to suffer social stigma. In particular, she mentioned the necessity of expanding nursing personnel in addition to disaster emergency. It is important to be prepared to avoid the hassle of increasing the number of nurses in a hurry due to Corona-19. Chairman Shin said, "It is very hard to work as a nurse once in a confirmed patient's quarantine. Two protective nurses have to go in every two hours, and the job itself is difficult and there is a fear that the nurse will spread the word to the family. A mother nurse is socially stigmatized and has trouble in her daily life". Chairman Shin said, “It is a big problem because they face and care for patients directly. Psychological treatment, physical support, and social follow-up measures are necessary, and it is also a way to have a regular nursing staff. It is difficult to recruit emergency personnel due to infectious diseases outbreak". Mok Hur, chairman of the National Health Center Directors' Council, said that even in the event of a national disaster, there is no support for public health centers, making night work a daily routine. Huh said, "There is no support for the public health centers for infectious diseases. We are actually fighting the situation with barehanded, and the reality is that even if we do not evade responsibility of the public health center in a national disaster. we have never left work since the last 20 days". "Health centers are directly affiliated with local governments and professional organizations, and people with a high level of administrative experience must be deployed, they move up like general auxiliary agencies, and they are upset, and we have asked the MOHW and the KCDC several times regarding the workforce but no change".
- Company
- Celebrex, resupplied as bottles of 100 capsules
- by Jung, Hye-Jin Feb 14, 2020 06:35am
- Cerebrex capsules, which are widely prescribed for rheumatoid and osteoarthritis pain medications, run out of stock. Pfizer Upjohn Korea recently announced that Celebrex 100mg 30 unit doses were sold out to distributors and medical institutions. Pfizer Korea explained that it will be resupplyed in early April and that Celebrex 100mg bottles of 100 capsules are normally supplied This is not the first time that Cerebrex is out of stock. Pfizer announced last June that Celebrex 100mg bottles of 100 capsules were out of stock. Out-of-stock period was for 6 months, and it has been resupply since early this year. However, as soon as Celebrex 100mg bottles of 100 capsules are resupplied, Celebrex 100mg cartons of 30 capsules are running at this time. Pfizer said the reason for the out of stock was a delay in production schedule.
- Policy
- “HIRA’s open ears and hearts for pharmaceutical industry"
- by Lee, Hye-Kyung Feb 14, 2020 06:35am
- "The Pharmaceutical Management Department had to move to Wonju, as the construction of second headquarter building of Health Insurance Review and Assessment Service has been completed. But its door is open. We plan to have our ears and hearts opened to the pharmaceutical industry." Kim Ae-ryun, appointed as a director of Pharmaceutical Management Department at Health Insurance Review and Assessment Service (HIRA), claimed 'integrity' as the top quality of a public Institute. But stated communication barrier should not be high. And she means HIRA is always ready to meet with pharmaceutical industry. First, the department had tried to manage the stakeholders visiting with an interview guideline. But now the department is gearing towards meeting everyone, and even with the director herself, if need be. Director Kim said, "The Pharmaceutical Management Department has opened a conference room for the visitor on the first floor of the first headquarter building. Pharmaceutical companies with questions can visit us without an issue. Transparency and integrity are the virtues a public institute should keep when working, but fundamentally the communication barrier should not hold them back." Previously a nurse, Director Kim started as reviewer at the DRG Department and served at Classification System Management Department. Later, she was in charge of healthcare reimbursement standard, fee-for-service management, new medical technology system operation and monitoring, and listing medical service at the Benefit Listing Department. With a lack of her experience in Pharmaceutical Management Department, pharmaceutical companies wondered of her personnel. The director explained, "Everyone knows that I do not have experience in Pharmaceutical Management Department. But I realized working here that my previous experience in reimbursement listing is similar to what I do now. I served as a director before and understood the common process. Now I see that the basic framework is similar and I plan to learn about the unique aspects of pharmaceutical listing as I go.” 40 days since her appointment as a director of Pharmaceutical Management Department, Director Kim has already had meetings with pharmaceutical industry organizations like Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA). When the Covid-19 outbreak subsides around March or April, the director plans to resume having quarterly conference with pharmaceutical industry. The whole office of Pharmaceutical Management Department has moved to Wonju last December. Regarding the issue of pharmacist officers leaving the office, Director Kim said, “One pharmacist resigned last December and another officer left this year. We’ve been here for two months and I think it’s a process. Korea spends about 25 percent of the total medical expense on pharmaceutical expense. And the Pharmaceutical Management Department takes care of most of drug items. Out of many other career choices a pharmacist can choose, a public office pharmacist is a great choice to feel worthwhile and find value in working.” “Aside from a type of occupation, we hope many of pharmacists can join us as they could be a huge help to the people’s health and patients. Government office pharmacist would be a great opportunity to help out with National Health Insurance finance management,” Director Kim added. The director did not comment much about the Drug Reimbursement Evaluation Committee selecting choline alfoscerate for the listed drug reevaluation pilot program. Director Kim assured, “I hope the reimbursed drug reevaluation system takes its root in Korea well as it takes a first step in Korea. This year’s goal for HIRA is to make a guideline to reasonably and transparently select subject drugs. The DREC’s decision has been made, but the department would listen to government and stakeholders’ voices along the way.”
- Policy
- Constipation drug Rucalo gets coverage but with condition
- by Lee, Hye-Kyung Feb 14, 2020 06:34am
- A new reimbursement standard has been added as Yooyoung Pharmaceutical’s chronic constipation treatment Rucalo tablet (prucalopride succinate) has been listed for reimbursement. Korea’s Ministry of Health and Welfare (MOHW) announced on Feb. 6 the authority has decided to grant reimbursement on Rucalo tablet by partially amending ‘Details of Pharmaceutical Reimbursement Standard and Method.’ The drug is currently indicated to treat patients with chronic constipation, who have failed to relieve symptoms regardless of administering two or more types of laxatives (form-bulking or osmotic laxatives and etc.) for over six months. According to the reimbursement standard, however, MOHW would renew reimbursement status after reviewing the patient’s state after four weeks of administration, and any other off-label use of the drug would be covered entirely by the patient. MOHW’s decision on the reimbursement was based on the drug’s indication, related academic society’s advice and external reference guideline. The drug is reimbursed in A7 countries like the U.K., Germany, Italy and Switzerland. So far, five Korean pharmaceutical companies have applied for reimbursement on chronic constipation treatment, including Yooyoung Pharmaceutical, Hana Pharm, Daewon Pharmaceutical, Ahn-gook Pharmaceutical and Huons. Result of DREC’s reimbursement feasibility review At the ninth Drug Reimbursement Evaluation Committee (DREC) meeting convened in last October, the committee had evaluated Rucalo, Prolo, Procal, Prucal, and Constipan demonstrated clinical efficacy, but they are expensive compared to other alternative options. The committee stated the reimbursement would be granted when the respective companies accept pricing under the evaluated price. Other than Yooyoung Pharmaceutical, another company has decided to accept the pricing lower than DREC’s evaluated price (weighted average of alternative options) and negotiated with National Health Insurance Service (NHIS) over pricing from last November. But only Yooyoung Pharmaceutical has reached an agreement and won the reimbursement. Rucalo is a selective serotonin (5-HT4) receptor agonist used to treat patients with chronic constipation, who does not respond to conventional laxatives.
- Company
- 4th IL inhibitor Skyrizi takes steps towards reimbursement
- by Eo, Yun-Ho Feb 13, 2020 06:29am
- The fourth interleukin medicine in Korean market, Skyrizi has started its reimbursement listing procedure. Pharmaceutical industry sources reported AbbVie Korea recently submitted an application for reimbursement on interleukin-23 (IL-23) inhibitor Skyrizi prefilled syringe (risankizumab). As a follow-on drug, the medication is predicted to accept the alternative drug weighted average price and promptly complete the listing process by the end of coming June. When the syringe receives reimbursement, the interleukin medicine market would be led by four competitors. Besides Skyrizi, Novartis’ IL-17A inhibitor Cosentyx (secukinumab), Lilly’s IL-17 inhibitor Taltz (ixekizumab), and Janssen’s IL-23 inhibitor Tremfya (guselkumab) are available in Korean market with reimbursement. All four medications are indicated for treating psoriasis and they are expanding indications on other autoimmune disease-treating fields. Professor Youn Sang Woong of Seoul National University Bungdang Hospital explained, “Severe psoriasis can seriously affect patient’s quality of life with physical, mental and social difficulties and pain. Each patient differs vastly in treatment response, and experiences various adverse reactions due to long-term treatment.” “During a Phase III trial, 90 percent of patient group administered with Skyrizi improved symptoms at over week 16, and 80 percent of them still maintained the improved state even after a year. The medication would be a new treatment option to improve symptoms of severe psoriasis and for maintenance therapy,” the professor added. In last December, MFDS indicated Skyrizi for treating adult patient, who needs phototherapy or systemic therapy (including biological therapy), with severe-level plaque psoriasis. Its indication was approved based on UltMMa-1 and UltMMa-2 trials, where patient group treated with Skyrizi showed high level of condition improvement at 16 weeks. 82 and 82 percent of the patients achieved Psoriasis Area and Severity Index (PASI) 90 at one year (52 weeks), and 56 and 60 percent of the patients achieved PASI 100, respectively. PASI 100 indicates the patient’s condition has achieved a complete resolution. Skyrizi administration starts with 150 mg initiation dose injected subcutaneously at week 0 and 4, followed by injection at every 12 weeks. Among the biologic IL-23 inhibitor class medicines approved in Korea, the treatment has the minimum administration frequency of four times a year, and it can be injected at a hospital or a patient can self-inject after training.
- Product
- Ebola drug Remdesivir is used to treat COVID-19
- by Lee, In-Bok Feb 13, 2020 06:28am
- Remdesivir by Gilead, which is being developed as an Ebola treatment, is expected to benefit significantly from the spread of COVID-19. The explosive demand for therapeutics around the world has led to unintended recruitment of clinical trials, which has resulted in significant time and cost savings. In some cases, the possibility of quick permits is also increasing. Clinical trials in the US, China, etc, Skip Prior Authorization The National Institute of Allergy and Infectious Diseases (NIAID) announced on the 12th that it will begin a clinical trial of Remdesivir with COVID-19. Remdesivir is a drug that Gilead Science is developing for the Ebola virus, and it is preparing for phase III full-scale after completing phase II clinical trials, However, the analysis predominates that the recruitment of the Ebola virus patient population will be limited and it will take some time due to the budget and time constraints for multinational clinical trials. It is a fact that some aspects of the permit has been placed in a somewhat opaque situation. However, with the rapid rise of Remdesivir in the treatment of new COVID-19, the demand has risen sharply and the environment is ready for immediate clinical trials without prior review and approval. This has been decisive in the case of the first COVID-19 patient from the United States. Indeed, researchers in the Centers for Disease Control and Prevention (CDC) have received a lot of attention from the New England Journal of Medicine (NEJM), with a case report describing the first patient prescribed Remdesivir. At the time, the patient was given other antiviral agents and antibiotics, but the symptoms got worse. Eventually, the administration of Remdesivir improved significantly. Since the Ebola virus is an RNA virus such as COVID-19, Remdesivir, which has a mechanism that prevents RNA replication, also inhibits COVID-19. NEJM Case Report Critical Leads to a quick permit As these effects become known, patients in China and Thailand are already taking Remdesivir in patients. The Chinese government has also urged Gilead to cooperate urgently and to expand the supply of Remdesivir. The same is true for large-scale clinical trials in China ahead of the United States. As soon as the potential for treatment was recognized, the Chinese health authorities immediately approved the medication in the form of clinical trials without prior review or approval. As a result, China has already entered into a controlled trial of 761 patients and is planning to proceed with the trial until April, and then review the rapid approval. This is not the only case in China. The U.S. Food and Drug Administration (FDA) and the CDC also mention rapid approval. Since the drug is already in the form of phase III clinical trials, it is in a position to grant a new drug based on this result. This fact has already been communicated to foreign countries through the New York Times and international press, and for this reason, China and Thailand are reportedly preparing for clinical trials and rapid approval. At the end of last year, the drug, which had even entered phase III clinical trials, was opaque, and in a few months, the phase III clinical trial could be approved for rapid approval. For Gilead, this is a great opportunity to save a great deal of time and budget in collecting patients, selecting institutions, and systematically analyzing them to prepare for permits. However, it is confirmed that clinical trials and rapid approvals are not being reviewed in Korea yet. As China's demand is so large that it attracts the world's quantity, it is not easy to consider prescription even in Korea. "Remdesivir is expected to be effective, but it is not easy to even prescribe it due to the lack of stock in our country, and for this reason, the policy recommendation was to exclude from primary treatment", said Jihwan Bang, the team leader of the central clinical task force (TF). An official from the Ministry of Food and Drug Safety said, "No immediate approval has been reviewed regarding COVID-19 treatment".
- Company
- Who will distribute Lamisil?
- by Jung, Hye-Jin Feb 13, 2020 06:28am
- GlaxoSmithKline Consumer Health's 'Lamisil' distribution network is distant. All rights reserved by Dong-wha have been transferred to Ildong. Only Lamisil has been missing and haven't found a supplier for over a month. Wholesalers and medical institutions are holding back their existing inventory and are very nervous about their short expiration dates. Lamisil has not been available since January, according to retailers and pharmacies. GSK products supplied by Dong-wha until last year are 10 items including Lamisil, Otrivin, Voltaren, Nicotinell, Theraflu, Sensodyne, Brethe Right, Zantac, Polident, and Diclor. Ildong signed a co-promotion agreement on only nine items except Lamisil. As the rights were transferred from Dong-wha to Ildong, only Lamisil has been lost. The distribution industry believes that Ildong Pharm has already given up the products because of its similar efficacy. Ildong signed a co-promotion agreement with Bayer in 2013 to supply Canesten creams, vaginal tablets and powders. Canesten cream is an antifungal agent for infectious diseases, and is widely prescribed for vaginitis and athlete's foot. The two products have different ingredients, but they are both cream-type athlete's foot treatments and both are classified as 'parasitic skin disease agents'. From the standpoint of Ildong, it is likely that a pharmaceutical company would be difficult to sell two similar items, and the decision could be a violation of the contract for two companies that signed a co-promotion agreement. The problem is that the company that distributes Lamisil has not been confirmed until mid-February. Wholesaler Zuellig Pharma Korea has been negotiating with GSK since last year for a sales contract, but it is reported that it has not reached an agreement on margin. wholesalers and pharmacies suffer from Lamisil’s short stocks. Most wholesalers and pharmacies have stocks of Dong-wha, but they are in danger because they have short expiration dates. An pharmacy official said, "Because imported goods take 5~6 months from customs clearance, even if they are produced at the same time, the expiration date is 6 months shorter than domestic products and there aren't a lot of Lamisil stocks available for sale". In response, GSK explained that Lamisil will soon be resupply. GSK officials said, "The internal process related to the contract is in progress, and it is possible to resume supply as soon as the related contract is concluded. We are making every effort to minimize the impact on the market demand".
- Policy
- COVID-19 primary antivirals Kaletra·Chloroquine recommended
- by Lee, Jeong-Hwan Feb 13, 2020 06:28am
- The central clinical TF will recommend antiretroviral agents Kaletra, antimalarial agents Chloroquine, and Hydroxychloroquine as the primary antiviral drugs for COVID-19. Ribavirin and Interferon, which are mentioned as COVID-19 drugs, have relatively high side effects and are not recommended as primary antiviral drugs. In particular, some patients confirmed that they could be cured by autoimmunity without antiviral medications. The old and severe patients were advised to consider antiviral medications. On the 11th, the Central Clinical TF held its fifth videoconference and said, "COVID-19 antiviral treatment agreement is being drafted and a TF agreement will be reached within a few days". The central clinical TF consists of medical staff and specialists from the national COVID-19 confirmed patient care hospital, centered on the National Medical Center. A total of 10 medical institutions and 20 experts participated in the 5th meeting to find out the diagnosis of patients in each institution, review discharge criteria, antiviral use criteria, systematic collection and research cooperation of clinical information, prevent unnecessary social confusion, and topics include formal briefing regularization issues to provide prompt and accurate information. A prominent part is the recommendation for antiviral administration. The central clinical TF is in consensus on COVID-19 antiviral treatment. Drugs to be considered for primary administration include AIDS treatment Kaletra and malaria treatment Chloroquine and Hydroxychloroquine. Ribavirin and Interferon are also mentioned as treatments, but the side effects are relatively high and TF is not recommended as primary drugs. Regarding the discharge criteria associated with the fourth discharge patient (No. 11), the TF said that the standards for release of quarantine were applied in MERS. If the viral gene is not detected twice in a row after 48 hours after clinical improvement of symptoms, it can be released. In fact, 11th confirmed patient who was discharged for the fourth time on the 10th was diagnosed with symptoms of the 6th patient's family. The symptoms improved from the 3rd and discharged after being negatively assessed by viral genetic tests on the 5th and the 7th. The TF said that it will enable the first-time clinicians to treat infectious diseases abroad for the future operation to quickly identify the characteristics of the disease and to create the basis for treating and responding to infectious diseases. Since the 3rd, they have been sharing and discussing patients' treatment experiences through three video conferences every Monday, Wednesday and Friday. It was diagnosed that COVID-19 air transmission could not be determined about the number of patients and the possibility of air infection on the Japanese cruise ship, which is a national concern. Air propagation (droplet infection) is rare, because the density of pathogens is so important that the disease cannot be transmitted to distant people. The emergence of a large number of patients from Japanese cruise ships is a situation where many people are crowded in a confined space, where direct and indirect contact and splash propagation can occur frequently. TF said that there are four infectious diseases that have been clearly identified as airborne, including measles, tuberculosis, smallpox, and chickenpox. "We are working with the KCDC and the MOHW on a variety of topics, including clarifying the role and status of the TF as soon as possible, evaluating patients for possible discharge, developing clinical guidelines, cooperating with the WHO, and making efficient use of medical resources, and in order to accumulate the ability to cope with emerging infectious diseases, and a permanent committee needs to be operated in a developmental form".
- Policy
- Antidepressant Pristiq’s first generic seeks approval
- by Lee, Tak-Sun Feb 13, 2020 06:27am
- Pfizer Apparently, generic makers are knocking on the door of depression medication Pristiq ER tablet. This is the first time the original’s saline base-modified drug is applying for an approval. On Feb. 10, Korea’s Ministry of Food and Drug Safety (MFDS) notified the Pristriq’s patent holder Pfizer that a drug with desvenlafaxine, the original’s active pharmaceutical ingredient (API), on modified saline base has applied for clearance on Feb. 6. The original Pristiq ER tablet used succinate as a base, but the investigational drug has based the API on benzoic acid. The generic’s approval application has been predicted long before, as Pristiq’s post-marketing surveillance (PMS) period of six years has expired on Feb. 5. Although a company launching a new drug in Korea is imposed with a duty to conduct PMS for a set period of time, the original is protected from generic makers with the same API applying for approval during the period. As a result, generic makers have waited for the original’s PMS period to expire on Feb. 5 and applied for approval straight away. However, the antidepressant generics are unable to launch immediately despite MFDS’ green light, as the original has patented the saline base, expected to expire on Oct. 7, 2022. For immediate release, the generic makers would have to challenge the patent, and the approval processing should undergo under the premise of launching the product regardless of the patent. The conditions are stipulated by the Drug Approval-Patent Linkage System. However, the group of applicants seeking for clearance on their generics seems likely to release the product right away. In last July, five companies have requested for negative confirmation of patent scope and successfully evaded patent infringement. Whan In Pharm, Myung In Pharm, Hanlim Pharm, Nexpharm Korea, and Samjin Pharm are the companies. As Pfizer is not filing an appeal against the case, their patent infringement is close to a done deal. If all the five companies have applied for desvenlafaxine generics on Feb. 6, they could win preferential sales rights on those items, because they have fulfilled three conditions—first to request trial, successfully challenged patent, and first to apply for approval. Pfizer’s Pristiq ER tablet has been evaluated as a next generation depression medication as it has lower risk of drug interaction and less frequent adverse reaction reported like body weight change or sexual dysfunction. According to UBIST last year, the original drug has generated 3.1 billion won from outpatient prescription. Although the drug has sold lesser than other 10-billion-won-club Lundbeck’s Lexapro and Lilly’s Cymbalta, the drug has promising prospective as the antidepressant market in Korea has skyrocketed recently and surpassed 150 billion won. Assessing the changes in the market, central nervous system (CNS) drug-specializing pharmaceutical companies have been eyeing on Pristiq’s follow-on drugs. Pristiq ER tablet is administered once-daily to adult with depression. The generics with modified saline base have applied for indication with same effect and administration method.
- Opinion
- [FOUCS] Fundamental issues with listed drug reevaluation
- by Kim, Jung-Ju Feb 13, 2020 06:27am
- The government is currently fine-tuning the detailed draft of Pharmaceutical Reevaluation Standard and Method. Although the initial drafting schedule disclosed at last year’s meeting with pharmaceutical industry and public hearing has been delayed, the government’s commitment on the task is still strong regardless of the urgent issues like the infectious disease outbreak. Ministry of Health and Welfare (MOHW) and Health Insurance Review and Assessment Service (HIRA) have briefed the draft of reevaluation guideline at the Drug Reimbursement Evacuation Committee’s (DREC) February meeting and mentioned of some changes and selecting subjects for pilot program. Apparently, the previous framework of already-listed drug reevaluation would be applied and the initially planned foundation would be kept, but JADAD scoring and other issue the pharmaceutical industry has strongly opposed would be dealt more flexibly. The pilot program would highly likely to begin with choline alfoscerate, as expected. The pharmaceutical companies have been skeptical of the pharmaceutical reevaluation system. They claim the current post-reimbursement management systems like price-volume agreement system and preliminary drug price reduction system would inevitably overlap with the reevaluation. And also they argue the government would face difficulties in surveying actual transaction price when referencing external drug pricing. Also there are polarizing views on gap between definition of Ministry of Food and Drug Safety’s (MFDS) ‘efficacy’ and MOHW’s ‘effect’ in the evaluation. For drugs like rare disease treatment with difficulties in conducting randomized clinical trial (RCT), the companies question if the regulators would be able to properly evaluate the drugs with universal validity and predictability. The industry is already concerned of reevaluating the drugs again with government-confirmed clinical efficacy and cost-effectiveness under unified standards. Expecting there is an ultimate goal of pricing reduction, the industry views the government would take different forms of reevaluation depending on various situation fitting to their goal. Choline alfoscerate, the government has set its mind on for the pilot program, is a good example. Because of its unique quality, it is difficult to conduct a RCT so applying unified standard has its limits. What it comes down to is which methodology the regulators would take. Regardless of MFDS maintaining the approval, adjusted reimbursement standard could restrict reimbursement on certain indications, and in worst case scenario the drug could be removed from the listing. Such nature of the drug well-illustrates how complicated the issue is. The industry claims it is an over-regulation that choline alfoscerate, five years since its release, now has to prove ‘effectiveness’ to MOHW and HIRA, even after it has recently revalidated its efficacy due to license renewal regulated by MFDS. For the authority it may seem like one whole regulation, the evaluated subject feels the burden of undergoing evaluation by each ministry. With the access to drug fast improving, the global trend of health regulators leaning heavily on post-management is clearly unavoidable. However, the authority should not neglect the concerns raised by the pharmaceutical industry, in other words the evaluated subjects. Like any other regulation, meticulously perfect regulation is extremely hard to come by to begin with. But a regulation with such significant influence on the survival of business and industry’s ecosystem should construct principles fastidious but lenient enough to tolerate exception. This would be the reason why the industry is paying close attention on the regulation still in development.
