- LOGIN
- MemberShip
- 2026-04-11 18:25:00
- Policy
- Data for reevaluation to be submitted from the 24th
- by Lee, Tak-Sun Oct 05, 2022 06:11am
- The data submission system for reevaluation of listed drugs that was set to be operated as of the 1st of this month will be operated from the 24th. The authorities plan to receive data submitted before then through the Health Insurance Review and Assessment Service’s e-mail. With the data submission system not being initiated in time, the industry has repeatedly been pointing to the administration's lack of preparation. Voices are continuing to rise in the industry to postpone the reevaluation of listed drugs in consideration of the circumstances, including the COVID-19 situation. According to the industry on the 3rd, HIRA has been notifying through associations that the data submission system for reevaluation of listed drugs that was set to be serviced from the 1st will be serviced from the 24th. Data submission is important to prove as the drugs subject to evaluations need to meet the reevaluation requirements or receive discounted ceiling prices depending on their degree of satisfaction. The health authorities have been requiring companies to submit data proving that the standard requirements were met to HIRA from the 1st of this month to February 28th next year. The standard requirements that need to be submitted are self-bioequivalence test data or evidence of clinical trial performance; and documents proving the use of APIs registered in the Drug Master File (DMF). If the subject drug satisfies both requirements, the ceiling price is maintained as is; however, if the drug satisfies only one of the two requirements, the price is reduced to 85%, and to 72.25% if both requirements are not met. As most listed drugs satisfy the DMF requirement, the self-bioequivalence test data will become the determining factor for the price discounts. The Ministry of Health and Welfare first applied the requirements to drugs that were newly listed from July 2020, and provide a grace period of 3 years for previously listed drugs. Therefore, the price adjustments for the listed drugs are planned on July 2023. To meet the self-bioequivalence test requirement, companies have switched their consigned products to in-house production and conducted self-bioequivalence tests. However, the COVID-19 outbreak in 2020 rendered the progress of the tests difficult, raising the suggestion that the entire revaluation schedule should be postponed. However, the MOHW decided to conduct the reevaluation of listed drugs as scheduled with some exceptions, with the goal of making price adjustments in July next year at the Health Insurance Policy Deliberative Committee meeting that was held on the 29th. However, the Ministry of Food and Drug Safety extended the data submission deadline for some oral preparations and sterile preparations among prescription drugs that were designated and subject to bioequivalence tests by 5 months, and the reports will be accepted if they are submitted by the end of May. Data on all other items will have to be submitted to HIRA by February 28th next year, as initially scheduled. Data submissions started on October 1st, but the authorities will have to wait another 20 days before the electronic window opens. Of course, the companies may submit their data via e-mail, but complaints about the delay in the industry are fierce as they are already pressed for schedule. An industry official said, “The government seems to not be ready to conduct the reviews that they have hurried the companies to prepare. With the 20-day delay in the data submission system, I wonder whether HIRA will be able to complete the review within the set period for the NHIS to complete pricing negotiations.
- Policy
- Pfizer Corona vaccine passed a verification advisory group
- by Lee, Hye-Kyung Oct 05, 2022 06:10am
- The Ministry of Food and Drug Safety (Director Oh Yoo-Kyung) announced on the 30th that Pfizer Pharmaceutical's COVID-19 vaccine "Comirnaty 2 0.1mg/mLP (Initial Virus of COVID-19, Omicron (BA.1)") passed the COVID-19 vaccine safety and effectiveness verification advisory group. The advisory group held a meeting on the 29th and proved its effectiveness in comparing the immune response of the neutralizing antibody with the existing vaccine after inoculating "Comirnaty 2 0.1 mg/mL", and judged safety to be similar to the existing vaccine. Seven people, including infectious medicine specialists and vaccine and pharmaceutical experts, attended the meeting of the verification advisory group. The Ministry of Food and Drug Safety will refer to the results of vaccine experts' consultation on the safety and effectiveness of the vaccine, including infectious medicine specialists, and quickly and closely review the submitted clinical, nonclinical, quality, and GMP data to decide whether to approve it. The Ministry of Food and Drug Safety said, "We will continue to do our best to supply safe and effective vaccines to our people."
- Policy
- Post-marketing surveillance of breast cancer drug Kadcyla
- by Lee, Hye-Kyung Oct 04, 2022 06:07am
- A total of 31 serious adverse reactions (ADRs) whose causal relationship cannot be ruled out had been reported as results of the 8-year post-marketing surveillance (PMS) on Roche Korea’s second-line breast cancer treatment ‘Kadcyla (trastuzumab emtansine).’ With 163 additional cases of unexpected ADRs whose causal relationship cannot be ruled out also being reported in the same period, Kadcyla’s label will be changed. The Ministry of Food and Drug Safety announced it will change the label for Kadcyla inj. 100mg and 160mg according to the reevaluation results as of December 28th. Kadcyla received domestic marketing authorization in January 2014 to treat patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who had previously received trastuzumab and a taxane (separately or in combination). The drug has been approved for reimbursement since August 2017 in Korea. Also, the drug was also additionally approved by the MFDS as an adjuvant monotherapy for patients with early HER2-positive breast cancer who had residual invasive disease after completing neoadjuvant therapy containing trastuzumab and taxane in August 2019 and was listed for reimbursement in July this year. At the time of the Health Insurance Review and Assessment Service’s reimbursement evaluations, the committee deemed Kadcyla’s pharmacoeconomic evaluation results to be at an acceptable level compared to its competitor Herceptin and acknowledged that the drug was listed in all A7 countries. Through drug pricing negotiations with the National Health Insurance Service this year, the company agreed with the authorities on adopting the utilization cap type of the Risk Sharing Agreement and set the price at KRW 1,956,328 per vial for the 10mg dose and at KRW 2,930,920 per vial for the 160mg dose. Results of the post-marketing surveillance that was conducted on 520 patients over the past 8 years showed that the incidence rate of adverse events were 74.63% (338/520 patients, 1590 cases) regardless of causal relationships. Serious adverse events were reported in 12.69% (66/520 patients, 90 cases) of the patients. As a result of the 6-year post-marketing surveillance conducted in 307 patients for the reevaluation, pleural effusion will be deleted and erythema and infection in the catheter area, bacterial arthritis, COVID-19, infectious spondylitis, and mastitis added as serious adverse events. Among these, 4.23% were serious adverse drug reactions (22/520 patients, 31 cases), based on which vomiting, shortness of breath, and pulmonary edema will be added to the label. The MFDS said, “We plan to change the label according to the Pharmaceutical Affairs Act and the Regulation on Safety of Drugs, etc. We ask hospitals, clinics, and pharmacies to ensure proper use of the drug.”
- Opinion
- [Reporter's view] Reimbursement of Zerbaxa
- by Eo, Yun-Ho Oct 04, 2022 06:07am
- Super antibiotic Zerbaxa will receive insurance benefits from this month. It is the first time in about five years that a domestic permit has been granted. The government's response to the application of the PE system to some of the national essential drugs, especially in the face of the seriousness of antibiotic resistance issues internationally, has made new antibiotic drugs. Even though it is not a "life-threatening disease," the need for important drugs has been recognized. Zerbaxa was approved in Korea in April 2017, but the prevailing view was that it was difficult to register under the system at the time. This is because new antibiotic drugs are not easy to prove cost-effectiveness compared to existing conventional drugs, and it is difficult to prove clinical superiority due to the nature of the drug. In fact, an application for Zerbaxa was submitted in the second half of 2018 and went through the procedure, but failed to pass the HIRA Drug Benefit Evaluation Committee in 2019. Since then, the government has implemented an improvement plan to include essential drugs such as antibiotics in PE targets as a way to expand coverage. The government designated antibiotics as PE targets, limiting the scope of antibiotics to antibacterial agents such as Zerbaxa. The medical concept of antibiotics refers to antimicrobial medics, which encompasses antimicrobial agents (treatment of bacterial infections), antimicrobial agents (treatment of fungal infections), and antiviral drugs (treatment of viral infections). This continuous increase in antimicrobial resistance is considered the most important public health agenda worldwide. The WHO defines the concept of AMR as 'a threat to the effective prevention and treatment of continuously increasing infections caused by bacteria, parasites, viruses and fungi'. AMR is not limited to the well-known superbacterial outbreak problem. Antibiotic resistance, also called Superbugs, refers to changes that occur when microorganisms (such as fungi, viruses, parasites, etc.) that cause infection, including bacteria, are exposed to antibiotics, antifungal drugs, and antibacterial drugs. In fact, the real liberation of antibiotics has not been achieved. As the benefits of step by step one goes a long way. Zerbaxa began, the medical environment in Korea has improved little by step. With a round of applause, it adds to the remaining concerns.
- Company
- Il-Yang “has not exaggerated COVID-19 trial results
- by Kim, Jin-Gu Oct 04, 2022 06:07am
- On the 29th, Il-Yang Pharmaceutical announced that it “has not exaggerated clinical trial results” regarding the ongoing police investigation on the company’s COVID-19 drug candidate ‘Supect.’ This announcement was made in response to one media report that Il-Yang Pharmaceutical is being investigated for exaggerating the clinical trial results for its COVID-19 drug to raise the stock price. According to the report, the police saw that the company had provided misleading information to investors, claiming that ‘Supect reduced COVID-19 infection by 70% within 48 hours of administration compared to the control group’ based on its non-clinical (in-vitro) trial results. With the news, the media added that Il-Yang Pharmaceutical’s stock price soared fivefold in four months, and the company's management sold a large number of company stocks in July 2020 at the peak price. During a phone interview with Daily Pharm, an official from Il-Yang Pharmaceuticals’ explained, “The investigation is currently complete, and the results are expected to come out soon. We have fully explained the company's position to the police." The official emphasized, “We have never exaggerated clinical data nor misled the public. Also, our management has never sold a large amount of stock.” “The manipulation of clinical data or sales of stock by management are all just accusations that were made unilaterally by some investors. The investigation was carried out because these investors repeatedly filed claims to the police.” “All clinical trials have the potential to fail. Failing a trial is not a crime. Also, we are not the only COVID-19 treatment developer that failed its clinical trial.” In March, in the early stages of the COVID-19 pandemic, Il-Yang Pharmaceutical announced in-vitro trial results that showed that the company’s leukemia treatment Supect reduced COVID-19 infection. Then, the company received approval to initiate a Phase III trial in Russia through the local pharmaceutical company, R-Pharm. In March of the following year, Il-Yang Pharmaceutical officially announced that it will abandon development as the company wasn’t able to demonstrate the drug’s efficacy in its Phase III trial in Russia.
- Company
- Pharmaceuticals trying to dominate Saxenda obesity market
- by Moon, sung-ho Oct 04, 2022 06:07am
- The pharmaceutical and bio industries' offensive toward the obesity treatment market is getting stronger day by day. It is making all-out efforts to judge obesity as a second "endocrine" market such as diabetes. Domestic pharmaceutical companies are also continuing to move beyond Saxenda and Qsymia, which are active in the domestic obesity treatment market. As it is related to other endocrine markets such as diabetes, pharmaceutical companies are more actively courting endocrine physicians who directly prescribe it, judging it as a market that can never be missed. According to IQVIA, a drug research institute on the 13th, Saxenda, and Qsymia are still active amid the growth of the obesity treatment market. The growth of Saxenda, which is at the forefront of sales, was remarkable. Sales of Saxenda in the first half of last year were 25.8 billion won, up 55% from the same period last year (16.7 billion won). If this continues until the second half of the year, it is worth expecting sales of more than 50 billion won as a single item. Qsymia, which used to threaten Saxenda, also recorded sales of nearly 14.2 billion won in the first half of this year, up 10% from 12.9 billion won a year earlier. However, the growth rate is relatively slow compared to Saxenda. Sales of the remaining obesity treatments such as Dietamin and Hutermine have rather slowed down. Focusing on the opening price, it was pointed out that the reason behind the surge in Saxenda sales was the influence of Corona and the cheaper price. Obesity treatment is a representative non-reimbursed market, and the average price of Saxenda has been up to 150,000 won, but recently, 70,000 to 80,000 won has been formed depending on the region, said the internal medicine director, who asked not to be identified. Hwang Hee-jin, a professor at the International St. Mary's Hospital (Family Medicine), an executive of the DAOR, said, "The Ministry of Food and Drug Safety has taken precautions against some doctors as it strengthened the management of psychotropic drugs," stressing, "It has no choice but to affect doctors' prescriptions." Amid the formation of obesity treatments centered on Saxenda and Qsymia, pharmaceutical companies are actively courting clinical field doctors to enter the market. As obesity is the cause of endocrine diseases such as diabetes, various measures are being devised to target endocrine doctors who are in charge of related treatment. # ICOMES 2022, which was recently held in a hybrid form, also revealed the will of pharmaceutical companies to the treatment market. Although most of the sessions were centered on online viewing, 37 domestic and foreign pharmaceutical companies, including Novonordisk Pharmaceutical and Chong Kun Dang, are actively setting up on-site booths and promoting the company's products. In addition to obesity treatments such as Saxenda, other diabetes treatments or treatment devices such as continuous blood glucose meters were set up to explain the product. In the case of booths by on-site pharmaceutical companies, the ratings were divided and arranged according to the level of sponsorship, according to pharmaceutical company officials who participated on the site. In other words, the higher the sponsorship rating, the better the location in the exhibition hall and the booth was installed. The pharmaceutical industry called the Obesity Society the "Second Endocrine Society" and evaluated it as a representative domestic society that has grown rapidly in a short period of time. At the same time, it is predicted that pharmaceutical companies' competition to sponsor academic organizations will intensify day by day due to the expansion of the obesity-related treatment market. Recently, it is specifying strategies for domestic companies to enter the market as well as Lilly's Tirzepatide, which is expected to be a new drug for diabetes and obesity centered on domestic academia. Starting with Hanmi Pharmaceutical's GLP-1 treatment Efpeglenatide, YH34160 of Yuhan Corporation GLP-1 series is also undergoing preclinical treatment. Kwangdong Pharmaceutical, which has Contrave, recently started joint development of an obesity treatment with QuadMedicine, a microneedle platform company. It is administered with a patch.
- Policy
- The price of Zerbaxa is listed at 60,098 won
- by Kim, Jung-Ju Oct 04, 2022 06:07am
- Zerbaxa, called the next-generation antibiotic for MSD Korea, will be listed at 60,098 won per vial as of the 1st of next month. Yuhan Corporation's allergic rhinitis treatment Ryaltris nasal spray 18ml is listed at 6,197 won and Ryaltris nasal spray 31ml is listed at12,396 won, respectively. The Ministry of Health and Welfare held a health insurance policy review committee today (29th) and announced that it was approved for the revision of the "drug benefit list and upper limit table" for a total of three new drugs. These drugs will be listed on the drug benefit list as of October 1 and sold at insurance prices. ◆Zerbaxa = This drug is an antibacterial agent used to treat complex intra-abdominal infections and complex urinary tract infections and was approved by the Ministry of Food and Drug Safety as of April 7, 2017. The company applied for insurance registration in early November last year and applied for insurance registration with the HIRA in November of the same year. The HIRA submitted it to the Drug Benefit Evaluation Committee in June this year for deliberation. At the time, the committee confirmed that clinical usefulness was inferior to that of the control group, and judged that the company's price was more cost-effective than the Japanese drug price, which is the lowest A7. Among the A7 countries, it was listed in the U.S., Japan, Italy, and the U.K., and the average adjustment price was 108,383 won per bottle. Since then, the Ministry of Health and Welfare has negotiated drug prices with the NHIS from June to August this year and decided on the expected amount of claims. The NHIS and the company signed an Expenditure cap RSA contract to refund the amount to the NHIS if it exceeds a certain amount (cap). The price was agreed to be 60,098 won per bottle, down 6.44% from the price passed by the evaluation committee, considering the number of patients who are eligible for more PE drugs such as anticancer drugs and rare disease treatments. ◆Ryaltris nasal spray = This drug, a treatment for seasonal allergic rhinitis, was approved by the Ministry of Food and Drug Safety as of June 22, 2020. The company applied for the HIRA insurance registration more than a year later on July 30, 2021. The HIRA introduced the drug and conducted deliberation on January 13 this year. At the time, the evaluation committee judged that it was more effective in relieving symptoms than a single drug in terms of clinical needs and that it was cost-effective as the company accepted less than 90% of the weighted average price of alternative drugs. It is listed in the UK and Italy among the A7 countries, and the adjusted average price is 16,308 won per 240 doses. In February, the company moved to the industrial complex to negotiate the expected amount of claims. Initially, the two sides conducted and completed negotiations for two months, but the application for registration was made after confirming the possibility of normal supply due to delayed imports due to COVID-19. It predicted that no additional finances would be required because alternative drugs such as Motesone plus Nasal Spray or Dylastine existed. The insurance price is 6,197 won for Ryaltris 18mL and 12,396 won for Ryaltris 31mL.
- Company
- Industry requests re-revision of the PE exemption standards
- by Eo, Yun-Ho Sep 30, 2022 05:54am
- The pharmaceutical industry raised opposition to the government’s proposed amendment to the insurance reimbursement system. According to industry sources, the Korea-Research Based Pharmaceutical Industry Association (KRPIA) submitted an opinion statement to the government regarding the pre-announced ‘Proposal for Partial Amendment to the Regulations on the Evaluation Standards and Procedures to Determine Eligibility for Reimbursement Benefits.’ In the statement, KRPIA requested revisions to the special exemption of pharmacoeconomic evaluations exemption system’s ▲‘few patient’ requirement ▲benefits for pediatric patients, etc. Korea Pharmaceutical and Bio-Pharma Manufacturers Association is also expected to submit a written opinion by the deadline, which is today (30th) to relay the same opinion as KRPIA. The two associations, which usually had different positions on government policies, seem to agree on this case. First, the KRPIA clearly expressed its opposition to the improvement plan that includes the "few subject patients" as a prerequisite. The improvement plan brought concern in the industry due to the fact that a major premise for the PE exemptions has also been changed. The condition had previously been an “OR” clause included in Article 2(c) of eligibility for PE exemption regulations, along with other clauses such as ‘if a single-arm study was conducted,’ etc. The association requested the government to maintain the regulation in its current state. KRPIA said, “Drugs that fall under Item 2(a) and 2(b) that have difficulty generating evidence were eligible for PE exemptions even if they were not used to treat ‘few’ patients. However, the revision mandates the ‘few’ condition to be met. This will only reduce the scope of eligible subjects.” The association also added that expanding the scope of PE exemption to pediatric patients, which the government had heralded as the purpose of the revision, also needs additional improvements. The government added a clause allowing PE exemption for ‘drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option; and demonstrates improvement in quality of life or is otherwise approved by the committee.’ In essence, the added clause excluded the “life-threatening disease” condition for PE exemptions just for pediatric patients. In other words, if drugs used for pediatric patients satisfy the remaining conditions, the PE exemption may be applied even if the condition is not life-threatening. However, the industry’s opinion is that the application of the standard should be extended. Through the written opinion, the KRPIA stated, “The government had first discussed expanding coverage to diseases that affect a small number of patients and bring a very poor quality of life even if they are not life-threatening in consideration of the characteristics of rare diseases. However, the benefit expansions made to pediatric patients or just main indications is limited and does not align with the government’s initial purpose.” To what extent the KRPIA and KPBMA’s opinions will be reflected remains to be seen. The Ministry of Health and Welfare and other subordinate institutions have been cautious about expanding the scope of the PE exemption system.
- Policy
- Strengthen the guarantee of 21 new drug by the third quarter
- by Kim, Jung-Ju Sep 30, 2022 05:53am
- From January to the third quarter of this year, a total of 21 new drugs were newly listed on the drug benefit list or improved access to use due to expanded insurance benefit standards. Among them, two new drugs were newly listed on the drug benefit list this month. The number of domestic patients estimated to benefit or suffer from the government's policy to strengthen the guarantee of new drugs this year is 1,323,065, and the cost of drugs is 451.75 billion won. In particular, with the emergence of ultra-high-priced drugs that focus on the minority, the government's drug guarantee and accessibility policy are becoming more flexible according to social trends and needs. A total of 21 drugs (based on the representative content) have been strengthened due to the expansion of standards among new drugs and registered drugs that succeeded in listing new drug pay lists from January to this month. On a monthly basis, Vyzulta and Skilarence were newly registered in February, and Besponsa's standards expanded, and the coverage began to be strengthened. In March, Xospata 40mg and five new osteoarthritis treatments, including Lutathera, Keytruda, Vitrakvi Rozlytrek, newly registered ultra-high-priced treatment kymriah in April, and Tecentriq in May. Looking at the recent drug coverage, the coverage of Kadcyla, a breast cancer treatment, expanded in the third quarter, starting with the new registration of Fexuclu, a treatment for erosive gastritis. In August, Zolgensma, a new drug for spinal muscular dystrophy, which was called an ultra-high-priced new drug and attracted social attention for a long time, was newly registered, widening the scope of drug coverage. Zolgensma's estimated number of patients in Korea is only seven but expected demand The cost of drugs reached 13.87 billion won, making it difficult to guarantee for a long time. Nevertheless, the fact that this drug was able to be paid can be said to be the result of our society's flexible expansion of coverage by recognizing the social importance, even if the number of patients is small. Subsequently, Sonazoid, radiation drugs for PET, Doppa check, Donerion and Dongesive, which are used for Alzheimer's-type dementia, were newly listed, and the standards for prostate cancer treatment Xtandi and urinary tract epithelial cancer treatment Keytruda, which had high patient needs, were expanded. This month, Pfizer Lorviqua and the chronic migraine drug Emgality succeeded in paying, allowing 350 and 2,344 patients, respectively, to receive benefits. The annual fiscal requirement estimated here is an absolute financial forecast. Among them, since RSA-applied drugs are calculated based on the indicated price, it is estimated that the actual amount required will be less than this considering the refund rate. In addition, the contents of the contract between the insurer and the company, such as the substitute drug and the sharing of required costs, were not reflected.
- Policy
- Reevaluation deadline for listed drugs extended 5 months...
- by Kim, Jung-Ju Sep 30, 2022 05:53am
- The government finalized its plan to extend the deadline for reimbursed price reevaluations of listed drugs that are subject to conduct bioequivalence tests and made a final report to the top legislative organization for the national health insurance. The finalized plan will extend the data submission period of listed drugs that are subject to reevaluations by 5 months, and companies that submit review results during the objection period for the Drug Reimbursement Evaluation Committee’s review after exceeding the submission deadline will also be accepted. The objection period on the Drug Reimbursement Evaluation Committee’s judgment will be around the end of May, and the final announcement period for the drug price cuts is scheduled for December next year. The Ministry of Health and Welfare held a Health Insurance Policy Deliberation Committee meeting on the 29th and reported the ‘Changes regarding the reevaluation of the upper limit (standards) set for pharmaceuticals.’ The reevaluation of listed drugs was made as a follow-up measure after the introduction of the stepped new drug pricing system that links approvals with drug price to ensure the quality of generic drugs and countermeasures against the flood of generics in the wake of the detection of impurities in valsartan-containing drugs in 2018. Since July 2020, all new generics introduced are applied a stepped pricing system under the new drug pricing system when determining its insurance price. The essence of the standard is to prove the results after conducting in-house bioequivalence tests. However, due to the spread of COVID-19, the bioequivalence tests that were to be conducted by the companies were not progressable due to difficulty recruiting subjects and the increase of confirmed COVID-19 cases among subjects which led to discontinuation or delays in trials and disrupted system implementation. Industry voices on the need for deadline extensions and deferred evaluations increased further due to the time taken in designating reference drugs necessary to demonstrate the bioequivalence of sterile drug products. Accordingly, the MOHW and the Ministry of Food and Drug Safety discussed flexibly adjusting the reevaluation procedure and schedule to facilitate smoother operations since May. In comprehensive consideration of the special circumstances that include preserving the consistency in insurance finances and the drug pricing system, equity with new products, and the prolonged COVID-19 outbreak, the MOHW decided to partially modify the data submission deadline and evaluation period, but with the goal of completing the schedule within 2023. According to the HIPDC report, the data submission deadline for existing items had been extended with a condition in consideration of the COVID-19 situation. The extension will be applied to 10,000 tablet preparations among oral prescription drugs and suppositories that are subject to bioequivalence tests. Among these drugs, if their bioequivalence tests have been delayed due to COVID-19, etc., the company may submit the test result report to the MFDS by February next year or submit the review results by end of May to HIRA within the planned objection period on HIRA’s Drug Reimbursement Evaluation Committee review, will be deemed to have met the final requirements. If the companies are unable to demonstrate bioequivalence within the set period, their drug’s price will be reduced as of July 1st next year. Authorities plan to identify progress made for bioequivalence tests by company and month within the second half of the year so that submission of bioequivalence test reports will not be concentrated in a specific period, and encourage prompt data submission to the MFDS upon completion. Adjustments to the reevaluation period will also follow. The government will also adjust HIRA's reevaluation period in consideration of the current designation status of reference drugs and MFDS's review schedule. The data submission deadline to HIRA is by July next year, and HIRA's evaluation period will be adjusted from July next year to November. With the changes, the drug price reduction announced for unproven products will be made around December next year. The MOHW will continue to monitor the progress of bioequivalence tests and the designation status of reference drugs and consult with MFDS and other related associations on issues to guide companies to disperse the submission of their reports.
