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- 2025-12-26 09:24:31
- Policy
- Only 6% of domestic medical staff received the vaccines
- by Lee, In-Bok Feb 25, 2020 06:12am
- A large number of university hospital staff in Korea are treating patients without even receiving a preventive vaccine recommended for medical workers. Even 93.5% of administrators for Hospital Infection did not have all the recommended vaccines. As most of the reasons for the difficulty in vaccinating are the cost burden, the government needs financial support. #The Korean Society Healthcare-associated Infection Control & Prevention (KOSHIC) conducted a large-scale national investigation of vaccinations among infection managers and healthcare personnel at member hospitals and published the results in the Journal of korean medical science on the 24th (doi.org/10.3346). /jkms.2020.35.e76). Since May 2018, researchers have surveyed vaccination status in a self-administered questionnaire in 652 member hospitals, of which 200 responded to specific surveys. The questionnaire includes the designation of an administrators for Hospital Infection, a hospital-level immunization policy, and the recommended immunization. The recommended vaccinations included influenza, MMR (measles, mumps, and rubela), TDAP (tetanus, diphtheria, pertussis mixed vaccines), and hepatitis vaccines, jointly recommended by the KCDC and the KSID. As a result, 172 hospitals (86%) have a vaccination policy, and there is an infection control room and medical staff to plan this. Of the 200 hospitals, 151 (75.5%) said they had a screening program for at least one antibody before recruitment. The most common screening program was hepatitis B, which was conducted at 74 % of hospitals before recruitment, with rubella (19%), measles (18%) and mumps (17%). However, less than 6% of the hepatitis A infections were tested beforehand. #196 (98%) hospitals were given vaccination against at least one vaccine related to the recommended vaccination. The most common is influenza vaccine, with 97.5% being inoculated, followed by hepatitis B vaccine with 69%. However, only 24.5% of MMR vaccines were vaccinated, 18.5% had chickenpox, and 11% had TDAP. Only 6.5% of hospitals included all five vaccines recommended by the KCDC and the KSID. 93.5% of hospitals have only one or two vaccines. As a result, as of 2017, 43 cases of medical staff were exposed to infectious diseases. Chicken pox was the most common (15 cases) and hepatitis B (11 cases). As such, each hospital was passive in vaccination because of the cost. When asked what was the biggest obstacle to implementing the recommended vaccination policy, 77% said it was due to financial burden. In addition, 21% of the respondents said that the awareness of vaccination was less than expected, and 21% of hospitals said they were due to the absence of vaccination campaigns. #In fact, the influenza vaccine, for example, the more the number of beds tended to increase the inoculation rate. As for the percentage of free vaccination projects, more than 700 beds recorded 100%, but 500 ~ 699 beds were 81.3%, 200 ~ 499 beds were 77%, and less than 200 beds were 72.1%. Sung-ran Kim, a professor of infectious medicine at Kyunghee University Hospital, who conducted the study, said, “The exposure to infectious diseases in hospitals is a serious problem that can lead to paralysis of hospital function. It is a big threat to the situation". Professor Kim said, “The biggest obstacle to the recommended immunization policy was the hospital's financial burden,and this means there is a limit to lowering these barriers without financial support from the government".
- Policy
- Nocdurna SL benefits are newly established
- by Kim, Jung-Ju Feb 25, 2020 06:09am
- Nocdurna SL tab’s identification picture (Source: the KPIC)The new benefit standard for the pituitary hormone, Nocdurna Sublingual tab (Desmopressin acetate), which is used for the treatment of nocturnal urine, will be applied from next month. However, because The drug’s benefit would be limited to only for idiopathic nocturnal polyuria, and it is not eligible for primary urination and nocturnal polyuria. The MOHW issued an administrative notice on amending ‘Pharmaceutical Reimbursement Listing Standard and Method’ on Feb 20 and released pharmaceutical standard. Ferring's Nocdurna SL is approved for the treatment of nocturia due to idiopathic nocturnal urination in adults. 50μg for males and 25μg for females are administered sublingually without water 1 hour before bedtime. Increasing dosed of desmopressin is not recommended in older patients 65 years or older, The drug has been included in the Desmopressin acetate formulation benefit standard, while receiving benefits from the Ministry of Health. However, it would be limited to idiopathic symptoms, and is not allowed to receive benefits for primary nocturnal enuresis 5 years and older. In addition, the treatment of nocturia symptoms associated with adult nocturnal urination is limited to use because it is applied only for idiopathic salary. The start date will be on March 1st. Desmopressin acetate preparations include Minirin by Korea Ferring, Demoresin Powder by Hanmi, Newlitan by Nexpharm Korea, Denerin fine granule by Pharmbio, and Demorin Fine Granule by Doonkoo.
- Policy
- The ruling & opposition parties agreed to COVID-19 committee
- by Lee, Jeong-Hwan Feb 24, 2020 06:27am
- The parliament barely agreed to form a special committee for the COVID-19. It will be officially launched when it is processed at the plenary session on the 24th. The official name was the National Assembly COVID-19 special committee, and the chairman was appointed by the Democratic Party. On the 20th, a member of the Democratic Party, Huduk Yoon, a member of United Future Party, Han Pyo Kim, and Jung-sook Chang, the head of the parliamentary negotiating group's three-party leader, made an emergency meeting at the National Assembly headquarters. COVID-19 chairman is chaired by the Democratic Party, the most seated. The proportion of members is nine Democrats, eight United Future Party, and one Democratic Unity Assembly. In addition, the ruling and opposition parties decided to act as the head of the National Assembly's intelligence chairman in the Democratic Party and the chairman of the education council in the United Future Party. The ruling and opposition parties will deal with the constitution of COVID-19 special committee, the selection of the chairman of the standing committee, and the agreement to appoint a justice of the Supreme Court,Tae-ak Noh.
- Policy
- Welfare committee passed a set of three bills about COVID-19
- by Lee, Jeong-Hwan Feb 24, 2020 06:25am
- The parliamentary welfare committee approved the three measures about COVID-19 at the plenary session on the 20th morning Three bills about COVID-19 were thus reviewed by the Legislation-Judiciary Committee. After passing through the judiciary committee, the final plenary session must be resolved before the final promulgation can be made. A revision to the infectious disease act calls for permitting the government to provide face masks for free to people who are vulnerable to infections when the country's contagious disease alert level is raised to the level above "caution", the measure also calls for doctors and pharmacists to check patients' records of foreign travel via a shared information program when they prescribe medication, for the establishment and monitoring of medical-related infections, and the increase in the number of epidemiological investigators. On the 20th, the Committee decided on 13 amendments in the Infectious Disease Prevention and Management Act, Medical Law and Quarantine Act. ◆Amendment to the Prevention and Control of Infectious Diseases Act=When a warning of abnormality was issued under the Basic Act on Disaster and Safety Management due to the spread of infectious diseases, a bill was issued to provide free masks to the vulnerable people such as children and the elderly who use social welfare facilities. In order to prevent recurrence of problems such as mask purchase disturbances, a bill that prohibits the export or export of goods such as masks and antiseptics during the period announced by the Minister of Health and Welfare if a sudden rise in prices or supply shortages such as medicines occurs due to the first-class infectious disease epidemic passed by the Welfare Committee The number of quarantine officials at the health ministry would rise to more than 100 from the current 30. In some cities, counties, and districts, there is a legal basis for mandatory epidemiological investigators. The bill also stipulates that health professionals, who are directly involved in patient care, prescription, and medication, such as medical workers, pharmacists, and heads of health care institutions, can check the patient's overseas travel information system at all times. However, the bill will not be punished even though it is not followed because the penalty clause has been deleted. ◆Amendment to the Medical Law=A bill was proposed to change the name of hospital infections to medical-related infections and legislation was passed to establish and embody justice. Evidence for compliance with medical institutions for the prevention of medical infections is also established. The medical system infection monitoring system was strengthened, and legal basis for self-reporting of infection control of medical institutions was also established. The extension of the designation and mandate of infection control personnel to all medical institutions, including local clinics, was removed from the subcommittee. ◆Amendment to the Quarantine Act=The point of Quarantine Act is that allows the Minister of Health and Welfare to ask the Minister of Justice to ban or suspend the entry into or through a country where a person is confirmed. The government has secured a legal basis for prohibiting the entry and entry of confirmed or suspected suspects in case of new infectious diseases such as COVID-19. The Minister of Welfare, Neunghoo Park, expressed his appreciation for the resolution of a set of three bills about COVID-19 by th Welfare committee. In particular, The Minister, Park requested adjustment only for the timing of the implementation of some provisions, and the Commission decided to accept the final decision. The Minister, Park said, "Some of the bills have been in force for six months after the promulgation. In consideration of the urgency and importance (of COVID-19), some provisions should be adjusted immediately and the penalty clause should be adjusted to one month of promulgation, and the provisions that define the definition of suspects, the self-containment facilities for suspected infectious diseases, and the provision of overseas travel history information provisions should be promptly promulgated, and the relevant penalties need to be adjusted one month after the promulgation".
- Policy
- Full inspection on BTX manufacturers and vaccine distributor
- by Lee, Tak-Sun Feb 24, 2020 06:23am
- Korea's Ministry of Food and Drug Safety (MDFS) plans to pin-point inspect 'botulinum toxin manufacturer' and 'chicken pox vaccine cold chain.' The focused inspection on biopharmaceutical would be completed by the first quarter. MFDS posted the 'Biopharmaceutical Manufacturer and Distributor Management Master Plan 2020 (biopharmaceutical, Korean medicine (herbal medicine), cosmetics, quasi-drug, and human tissue) on its website on Feb. 18. ◆ Special inspection on botulinum toxin and chicken pox vaccine cold chain: For the subjects of the focused inspection, MFDS headquarter and regional offices would audit botulinum toxin product manufacturer for their manufacturing and quality control in the first quarter. Currently, Medytox, Daewoong Pharmaceutical, Hugel, Huons, Pharma Research Bio, and BMI Korea are the six licensed botulinum toxin manufacturers in Korea. And the ministry plans to inspect all of them. Based on the report by a whistle-blower, the health regulators inspected the manufacturing facilities of Medytox and found quality control issue, which the company had to recall the products for. The ministry decided to further inspect every botulinum toxin manufacturers and aims to improve the credibility of the biopharmaceuticals. Previously, the regulator used to focus the chicken pox vaccine cold chain inspection on distributor, but the regulator would, for this year, inspect all process of cold chain from distributor to healthcare institute to confirm quality maintenance system and to seek improvement measures. Within the first quarter, the ministry headquarters, regional office and local government offices would cooperate to monitor the cold chain management of chicken pox vaccine. ◆ Regular inspection on seven biopharmaceutical GMPs: The three-year regular on-site inspection for the biopharmaceutical GMPs would be conducted as well. The subjects for this year’s regular inspection are Medipost (finished pharmaceutical product (FPP)), S. Biomedics (FPP), Eubiologics (FPP), CJ Healthcare (finished pharmaceutical ingredient), Corestem (FPP), Daewoong Pharmaceutical second plant (finished pharmaceutical ingredient) and TKM (FPP). ◆ Monitoring illegal advertisement of Saxenda-like self-injections: Charged for exaggerated advertisement in last year, appetite suppressant Saxenda injection and other prescribed self-injection’s mass media advertisement and illegal distribution would be monitored all year round. The mass media advertisement on poster, billboard, leaflet and online pop-up and banner ads on hospital, clinic and pharmacy website are subjects for monitoring. Also online advertisement, influencer advertisement and illegal online distribution through new media like social media channel, Youtube and Afreeca TV, are also subjects for the monitoring. ◆ Special inspection and quality test on respirator: Respirator, struggling to meet surged demand due to COVID-19, would be inspected thoroughly as well. Especially the manufacturers neglected from last year’s inspection for being temporary or permanent closed are included for this year’s inspection. The ministry would also monitor any toxic substance found in distributed respirator, and 90 cases of quality test conducted last year would be increased to 200 cases. The ministry and local government offices would cooperate and each test quality on 100 items all year. Online and offline retail stores would be monitored all the time as well.
- 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 .
- 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".
- 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.”
