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- 2026-05-15 22:34:46
- InterView
- “Roche reborn through customer-centric reorganization”
- by Eo, Yun-Ho Jun 21, 2022 05:54am
- Nic Horridge, General Manager of Roche Korea Multinational pharmaceutical companies are known to endlessly pursue change. In addition to active acquisitions, mergers, and spin-offs, the companies boldly reduce and expand their many originations in line with the new drug development trend, and show no hesitation in consolidating or reorganizing departments. Their endless evolution for efficiency and survival continues on even now. The same goes for Roche. Roche, which used to hold a strong image as a company specializing in anticancer drugs, have continued to maintain its strength in that area while expanding its interest to other diseases. The company released ‘Xofluza,’ a follow-up of its antiviral ‘Tamiflu,’ and is also spurring up the development of its new Alzheimer's treatment in CNS. The company had also undergone great change in the organization as well. The company had promoted ‘"agile transformation" at the global level to improve flexibility and responsibility as an organization. Unlike conventional organizations where employees are assigned specific products, at Roche, employees are assigned to each disease-specific indication. Roche Korea also joined in this transformative journey in 2018. In the process, quite a few issues in personnel adjustments and departures arose. General Manager Nic Horridge, who has been running Roche Korea for 4 years since being appointed GM in October 2018, has led this transformation in Roche Korea. Dailypharm met with Nic Horridge to hear about the transformations made and those to come for Roche Korea in the future. -Two years have passed since the company decided to undergo an agile transformation. What are the advantages of agile transformation? Agile transformation is an innovation that is being pursued at the global level to transform our organizational culture. In line with the rapidly changing healthcare technology, medical environment, and the exponential increase in information, Roche’s portfolio has continuously evolved and entered new treatment areas. The company had determined it would be difficult for Roche to achieve its goal of bringing the best results faster to our patients with the existing ways of business and operation model and decided to pursue agile transformation. We now have teams organized according to the treatment area or patient group to identify the practical needs necessary for each patient’s treatment journey and make optimal decisions. In the past, we had unmet needs in rapidly identifying how diagnoses and treatments were being made in areas unfamiliar to Roche, such as Alzheimer’s and Ophthalmology, but this organizational evolution now allows each team to rapidly identify, understand and strategize what’s needed. -The transformation process would not have been easy. How did the employees and executives at Roche Korea receive the change? We have now passed the adaptation period, and our efforts are now coming to fruition. The autonomous decision-making system was one thing that many employees and executives had first found difficult, as each employee, as his/her own leader, was required to contemplate and find an answer on 'what role he/she should play to bring value to the domestic medical ecosystem?’ Some employees have decided to part ways with the company in the process. I consider this positive as these former Roche employees continue to contribute to the development of the healthcare industry in their respective positions. At the time, we had candid discussions with the employees who believed the new business model was not right for them, and some had decided to seek new opportunities. In the process, younger employees were given the opportunity to take on a leadership role in the company, and this gave rise to fresh and new perspectives that could help achieve Roche's vision. The ideas were successfully incorporated into the organization. --Roche is developing ‘gantenerumab’ as a treatment for Alzheimer’s disease. Many other companies that have jumped into the scene are struggling, such as in the case of Aduhelm. What is your opinion on this? Roche’s gantenerumab is an anti-amyloid-beta monoclonal antibody that reduces brain amyloid plaques, which are known to induce brain cell death, to improve symptoms of Alzheimer’s disease. Its Phase III trial results are expected to come up in the second half of the year, and we are confident that we would be able to see good results. Also, in treating Alzheimer’s, Roche believes early detection of the disease is as important as new drug development. If a patient is prescribed treatment after his or her symptoms have progressed to a certain extent, the brain damage that has already occurred will most likely not be regenerated. Assuming that gantenerumab's clinical findings are successful, we believe that Roche’s approach of early detection and treatment will provide patients with an invaluable solution. -You served 4 years as the head of Roche Korea. What is your impression of the Korean healthcare ecosystem? I am pleased to have been awarded this opportunity to promote various changes in Roche Korea for the past 4 years. Due to the unprecedented crisis brought on by the pandemic, we have undergone many changes in our daily life and work, but I believe the Korean government showed excellent leadership in the containing COVID-19, and that Korea has received less damage than neighboring countries. This was very impressive. Statistics show that Korea’s accessibility to new drugs is 35%, which is significantly lower than other countries such as the US (87%), the UK (59%), and Japan (51%). Also, it takes an average of 601 days to reimburse listing, and new drugs account for only around 20% of the pharmaceutical expenditures spent in NHI finances. This is far below average in other OECD countries. I believe there would be a way to increase access to innovative drugs without significantly increasing the overall drug expenditure without affecting national finances. Roche will do its best to support the government in fulfilling its pledge on relevant tasks.
- Company
- Takeda Korea appoints Sun Jin Lee as head of Oncology BU
- by Jun 21, 2022 05:54am
- Sun Jin (Justine) Lee, New Head of Oncology BU, Takeda Pharmaceuticals Korea Takeda Pharmaceuticals Korea (General Manager HeeSeok Moon) announced on the 20th that it had promoted and appointed Manager Sun Jin (Justine) Lee as the Head of its Oncology BU. The new head, Lee, who joined Takeda Pharmaceuticals Korea as a marketing manager of the Hemophilia BU, developed creative marketing strategies and drew participation from internal and external stakeholders for its implementation. Lee played a pivotal role in improving the access and awareness of Takeda Korea's hemophilia business and demonstrated her leadership capabilities. In recognition of her leadership, Lee had led the product launch in the market as a Launch & Digital Excellence Lead in the Asia Pacific (APAC) region, and also successfully carried out projects such as presenting the vision and direction for the digital transformation of Takeda in the APAC region. it was recognized for its leadership capabilities, such as playing a pivotal role in improving the access and awareness of Takeda Korea's hemophilia business. Since then, he has led the product launch in the market as a Launch & Digital Excellence Lead in the Asia Pacific (APAC), and at the same time ha Junghun Kim, the former head of the Oncology BU, has been appointed Country Manager of Malaysia & Singapore in May through the 'FLP(Future Leaders Program)' that provides global networking opportunities for employees within Takeda Pharmaceutical. Kim joined Takeda Pharmaceuticals Korea as a marketing manager in 2015 and established the Inflammatory bowel disease and blood cancer BU. After being appointed head of the Oncology BU in 2019, Lee launched various innovative oncology products in Korea and exceeded the target for three consecutive years, and has been leading the company’s digital transformation in Korea. Under the value ‘Exceptional People Experience,’ Takeda Pharmaceuticals is committed to providing various experiences and opportunities for its employees to develop their capabilities. It also offers special programs for select key talents. The ‘FLP (Future Leaders Program)’, which provides global networking opportunities in Takeda, is one such program, and the recent personnel appointments were also made through the FLP. HeeSeok Moon, General Manager of Takeda Pharmaceuticals Korea, said, “The promotion has more meaning as it was achieved by Takeda’s professional development program. Takeda Pharmaceuticals Korea will continue its best efforts to support various programs for our executives and employees to develop their careers so that each and every employee may realize his or her full potential.”
- Company
- KIMS has signed a license agreement for Lipothasone
- by Nho, Byung Chul Jun 21, 2022 05:54am
- KIMS Pharmaceutical announced on the 20th that it has signed a contract with Japanese pharmaceutical company Mitsubishi Tanabe Pharma on the 17th to license Lipothasone. Through this contract, KIMS Pharmaceutical will officially release the product in August. According to KIMS Pharmaceutical, Lipothasone is the only Dexamethasone in Korea that uses Mitsubishi Tanabe Pharma's Lipid Nano Particle (LNP) technology. Steroids are excellent enough to be called panacea, but it is a drug that is reluctant to be prescribed due to serious side effects. Lipothasone is known to be a strong and safe anti-inflammatory treatment as well as targeted treatment of inflammatory areas by reducing the side effects of existing steroid injections, allowing IV, Epidural, and Intrathecal. In addition, this product is a drug carrier liposome (liposomalization) using DDS (Drug Delivery System) technology, and is considered to be a product that minimizes drug effect loss and minimizes side effects by selectively expressing effects on target lesions. Kim Seung-hyun, CEO of KIMS Pharmaceutical, said, "We are happy to have LNPS drugs through this contract." "We will continue to strengthen cooperation with Mitsubishi Tanabe Pharma Korea to promote mutual development and do our best to secure patients' access to new drugs," he said. KIMS Pharmaceutical is a company recognized for INNOBIZ, COVA, MAINBIZ, and HBA, and has a corporate research institute and a GMP plant in Osong, Chungcheongbuk-do.
- Policy
- The HIRA launched a benefit review for Tabrecta
- by Lee, Tak-Sun Jun 21, 2022 05:54am
- There are not many patients with MET mutation, but the prognosis is bad, so a treatment is urgently needed. It was found that the HIRA began a benefit review for targeted treatments for MET mutants, which appear in 3-4% of all non-small cell lung cancer patients. The MET mutation target anticancer drug landed in Korea in November last year with the approval of Novartis' Tabrecta and Merck's Tepmeko. Currently, it can be used as a non-reimbursement. According to the industry on the 17th, the HIRA has begun a process to determine the appropriateness of Tabrecta's benefit. Tabrecta was granted domestic permission on November 23 last year. It is the first drug used in patients with local progressive or metastatic non-small cell lung cancer where MET Exxon 14 deficiency was confirmed, and it was the first time that MET mutated targeted anticancer drugs were approved in Korea. MET mutations appear only in about 3-4% of all metastatic non-small cell lung cancer patients, but the prognosis is poor, so related targeted treatments are in urgent need. Tabrecta is known to block MET phosphorylation by binding to the phosphorylase region of receptors in cells. In the GEOMETRY mono-1 trial of 97 MET mutant patients, Tabrecta showed an overall response rate of 68% in patients who had never been treated and 41% in patients who had previously been treated. Tabrecta can be prescribed in major hospitals since early this year. However, since the benefit registration process is not completed, the patient must bear the price of about 10 million won. For this reason, the medical field is demanding rapid payment procedures. In the case of anticancer drugs, the HIRA's Cancer Disease Review Committee establishes standards, and then the Drug Reimbursment Evaluation Committee examines the appropriateness of benefits. It will be negotiated with the NHIS about the price and be placed on the final step through deliberation by the Health Insurance Policy Committee of the MOHW. Even if it goes fast, it takes about six months to get reimbursed.
- Policy
- Drug price cut refund bill’s fate depends on LJC Chair
- by Lee, Jeong-Hwan Jun 20, 2022 06:04am
- Industry expectations are rising on the prospect that the constitution of the NA leadership in the second half of the year will directly affect the fate of the Bill to recover and retrieve drug price cuts. If the People Power Party, which had been criticizing the inadequacy of the bill, takes Chair of the Legislation and Judiciary committee, it may significantly increase the possibility that the bill’s non-passage. On the 19th, the pharma-bio industry and the legal community are paying close attention to the progress made between the ruling and opposition parties’ negotiations regarding the composition of the NA leadership in the second half of the year. The National Assembly’s second half of this year’s term had started in June, but with the ruling and opposition party having difficulty agreeing on the composition of the NA leadership, the position of the Legislation and Judiciary Committee Chair has remained vacant for 3 weeks now. The determination of both the ruling and opposition parties to take the position has prolonged the confrontation even despite under-the-table negotiations. If the ruling party, the People Power Party assumes the Chair of the Legislation and Judiciary committee, this is expected to increase the possibility of the bill’s non-passage at the committee level. Therefore, on which party will assume Chair of the Legislation and Judiciary committee is expected to affect the bill for the recovery and retrieval of drug price cuts that can significantly impact sales and marketing in the pharmaceutical industry. The bill, which contains the measure for the government and pharmaceutical company to retreive or recovers the pharmaceutical benefits (reimbursement) amount that had not been settled during the drug price cut disposition suspension period, is currently pending in the 2nd subcommittee of NA’s Legislation and Judiciary Committee. The bill was proposed by members Woni Kim and Insoon Nam of the Democratic Party of Korea as representatives and passed NA’s Health and Welfare Committee with consensus between the opposition and ruling parties. However, the agenda was then put on hold by members of the People Power Party during review in the Legislation and Judiciary Committee’s plenary session. At the time, People Power Party member Joo-Hyae Jeon had criticized the bill for being unconstitutional. Jeon pointed out that the bill excessively restricts the pharmaceutical companies' right to file lawsuits to prevent them from applying for an injunction to suspend the execution of the drug price cut itself. Jeon added, “I want to express my deepest regrets on the fact that a bill that completely undermines the administrative litigation system has been put up for deliberation for the Legislation and Judiciary Committee. The bill requires the company to refund the whole amount of the drug price cut disposition that was not made during the execution suspension period, but this penalizes compulsory executions and neutralizes the suspension itself. The bill was unable to pass the plenary session then and was set to remain pending in the 2nd subcommittee of NA’s Legislation and Judiciary Committee for further review. The NA’s Health and Welfare Committee which believes in the need for the bill has set out to persuade the members of NA’s Legislation and Judiciary Committee, focusing on the PPP members that have opposed the bill, but to no avail. This is why there are prospects that the bill will not pass NA or be enacted if the PPP takes over the Chair position of the Legislation and Judiciary Committee in the second half of the year. With no decisive change or event arising for the PPP to change their mind on the bill, if the ruling party takes over the Chair position that can make or break the enactment of bills, experts believe that the possibility of the bill not being deliberated or being voted down may rise significantly. Also, the legal community and the pharmaceutical industry’s rising voices on the unjustness of the bill and strong opposition are also expected to hinder the passage of the bill. Therefore, on which party, the ruling or opposition party, takes over the Chair position of the Legislation and Judiciary Committee is likely to make or break the bill. An official from the pharmaceutical industry said, “Many domestic and multinational pharmaceutical companies have been strongly appealing and opposing to the unfairness and fatality of the refund and redemption bill, he said. "The reality is the appointment of the chairman of the Legislation and Judiciary Committee will inevitably affect the introduction, deliberation, and passage of the bill. This is why we are keenly following discussions on the composition of the NA leadership.” A lawyer from a Korean law firm who requested to remain anonymous, said, “From the legal community’s point of view, the bill nullifies the execution suspension system and overthrows the judicial system. From the pharmaceutical company’s point of view, they may not file a suit to cancel the drug price cut disposition or give up making appeals due to fear of the government's retrieval and collection of the drug price cut disposition amount after the trial. This by itself is an infringement of the right of access to courts and is against the constitution.”
- Company
- 11 of the national essential drugs are non reimbursed
- by Eo, Yun-Ho Jun 20, 2022 06:04am
- It was found that 11 of the drugs designated by The National Essential Medicine, excluding vaccines, are still non-reimbursed. As of December 31, 2021, 511 species have been designated as the National Essential Medicine, and 158 types of infectious disease-related drugs excluding vaccines. Of these, 11 drugs were not on the insurance benefit list. However, Remdesivir, a treatment for COVID-19, is not reimbursed, but the government pays the full cost of the drug. The national essential medicine refers to medicines that must be prepared in the country for national health, and was first discussed and introduced by the World Health Organization. Through the pandemic of infectious diseases such as MERS and COVID-19, securing stable national essential drugs such as vaccines and treatments for preventing infectious diseases is recognized as the core of national security and national competitiveness. However, it is pointed out that the problem of accessibility of the National Essential Medicine is still a blind spot. In fact, the National Health and Welfare Committee's parliamentary audit last year raised questions about the suspension of the supply of The National Essential Medicine and the low health insurance benefit registration rate. Non-payment drugs include Ceftolozane/Tazobactam injections (Zerbaxa), Isabuconazonium sulfate (Cresemba), Baloxavir (Xofluza), which had many clinical demands. Zerbaxa is an antimicrobial drug that was expected to be introduced in Korea as a new treatment alternative to Carbapenem, which was approved in Korea in April 2017 as an indication of complex urinary tract infection and complex intraperitoneal infection by effective strains in adult patients. Carbapenem-resistant-P. aeruginosa is one of the top-priority pathogens that require research and development of new antibiotics. Although Zerbaxa is an effective treatment for resistant bacteria that is not effective for Meropenem, it has been restricted from using Meropenem as an alternative and failed the benefit list despite high demand, but its appropriateness was recognized at the 6th Pharmaceutical Benefit Evaluation Committee held on the 2nd. Cresemba is an antifungal drug that was licensed and non-reimbursed in Korea in January 2020 for invasive aspergillosis and mucormycosis. Like Zerbaxa, it is blocked by PE, which has to prove cost-effectiveness by comparing old drugs with alternatives, and despite the occurrence of COVID-19-related inert aspergillosis in Korea, it is currently non-reimbursed. Invasive aspergillosis is one of the three major invasive fungi threatening humans, which occur in patients with reduced immunity, and is one of the causes of death in immunodeficiency patients due to the recent increase in chemotherapy or AIDS patients in Korea. The flu treatment Xofluza was a new drug that was expected to replace Tamiflu and was approved in Korea in November 2019, just before the COVID-19 pandemic. Since receiving conditional non-reimbursement from the Drug Benefit Evaluation Committee in October 2020, there has been no update yet. The experience of the COVID-19 pandemic has raised awareness of the rapid response of infectious diseases and the importance of drugs in policy and society, while access to infectious diseases, especially new drugs, remains before the pandemic. Since drugs related to severe infectious diseases such as multidrug-resistant infections and invasive fungal infections are used in emergency situations, it is essential to secure various types of drugs so that they can be used immediately if necessary. Choo Eun-joo, director of KSID's Insurance dept. (Professor of Infectious Medicine at Bucheon Hospital at Sooncheonhyang University), said, "There are no antibacterial and antifungal drugs that have been reimbursed for the past five to seven years. As drugs necessary for the treatment of fatal infectious diseases play a key role not only in the survival of individual patients but also in preventing the spread of infectious diseases, they should not be evaluated only from an economic perspective, she said.
- Company
- TNBC will be added to Keytruda's indications
- by Eo, Yun-Ho Jun 20, 2022 06:04am
- TNBC indications of the immuno-cancer drug Keytruda are expected to be added. According to related industries, the MFDS is currently conducting a last-minute review for further approval of the combination of chemotherapy in the first round of Triple-Negative Breast Cancer (TNBC) by PD-1 inhibitor Keytruda. Permission is expected within the third quarter. Since the approval of the U.S. FDA last year, MSD has been rapidly proceeding with the approval process. Keytruda's effectiveness in TNBC has been demonstrated through KEYNOTE-355 studies. In this study, Keytruda recorded 53% ORR (CR 17%, PR 36%) with PFS improvement in the entire patient population with a rapid recurrence of more than 6 months, suggesting the possibility of complete recovery in metastatic triple-negative breast cancer with high complete remission rates. On top of that, Keytruda recently proved its effectiveness in adjuvant therapy before and after surgery. As a result of exploratory analysis of the KEYNOTE-522 study published at the American Society of Clinical Oncology (ASCO) annual conference, both the keytruda administration group and the control group tended to increase the incidence of events rapidly as the size of residual tumors increased. In addition, with the exception of RCB-3, which has the largest size of gin tumors, the risk of occurrence of events in the Keytruda group was all lower than that of the control group. Among breast cancer, TNBC, which has negative reactions to all receptors (Estrogen, Progesterone, and HER2), has long been an unsolved challenge. TNBC's treatment options have long been all about chemotherapy and Roche's targeted anti-cancer drug, Avastin (Bevacizumab) acquired the first indication in Korea, but it is still nonreimbursed. Since then, a poly ADP ribose polymerase (PARP) inhibitor Lynparza has been added as a target anticancer option, and Roche's PD-L1 inhibitor Tecentriq has entered as the first immuno-cancer drug.
- Policy
- Hanmi obtains generic exclusivity for Dapalon Duo
- by Lee, Hye-Kyung Jun 20, 2022 06:03am
- Hanmi Pharmaceutical obtained generic exclusivity rights for its SGLT-2 antidiabetic combination drug ‘Dapalon Duo SR Tab (Dapagliflozin Bis L-proline/ Metformin Hydrochloride),’ a generic version of ‘Xiguo XR Tab (Dapagliflozin Propanediol Hydrate/ Metformin Hydrochloride). The Ministry of Food and Safety recently granted marketing authorizations for the four strengths of Dapalon Duo - Dapalon Duo 5/500mg, 10/500mg, 5/1000mg, and 10/1000mg. Its original drug is AstraZeneca’s Xiguo XR Tab, and Hanmi is the second company to receive first generic exclusivity for its four strengths after Chong Kun Dang. The generic exclusivity will be in effect from April 8th, 2023 to January 7th, 2024. Hanmi Pharmaceutical’s Dapalon Duo is a combination of dapagliflozin bis L-proline and metformin hydrochloride that uses a different solvate from the original Xigduo XR Tab on its active ingredient, dapagliflozin. Meanwhile, 53 Xigduo generic items from 24 companies have received marketing authorization, among these, 12 items from Chong Kin Dang, KyungDong Pharm, Ildong Pharmaceutical, Boryung Pharmaceutical, and Jeil Pharmaceutical have been granted generic exclusivity. The solvent patent for the original drug was set to expire on June 21st, 2027, but the invalidation claim filed by the latecomers in Korea has been accepted and has left the patent invalid. As the companies of latecomers have won the first and second trials to invalidate Xigduo’s the second substance patent which is set to expire on January 8th, 2024, the companies will be able to sell the latecomer items upon the expiry of the first substance patent that expires on April 7th, 2021. Xigduo’s outpatient prescriptions (UBIST) amounted to 36.9 billion last year.
- Company
- Hee-Mok Won to “strengthen ties with Korean talents in US"
- by Kim, Jin-Gu Jun 20, 2022 06:03am
- The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) announced on the 16th that it will establish a communication and cooperation network with Korean talents that serve key roles in regulatory agencies, pharmaceutical companies, and venture capital (VCs) in the US to support the domestic companies’ entrance into the US market. Hee-Mok Won, Chairman of KPBMA has recently visited the US to attend the 2022 BIO International Convention (2022 BIO USA) and the opening ceremony of the Korea Bio-Innovation Center in Boston. During his visit, Won had also participated in the “Seminar & Dinner Symposium for the Korean Pharma-Bio’s entry into the US market (Korea Night 2022).” The event was organized by the Ministry of Health and Welfare, the Ministry of Trade, Industry and Energy, and the US Embassy, and was jointly hosted by the KPBMA, Korea Health Industry Development Institute, KOTRA, and KoreaBIO. At the event, Won said, “Let us bring a successful era of K-Pharm together by creating a diversified, in-depth network that connects Korean talents that work in various fields related to the Pharma-Bio industry in the US.” Won added, “KPBMA has actively been supporting our member companies’ entrance to Boston, the world's largest bio cluster since 2019. We will also actively support cooperation between companies in bio clusters in Maryland, Silicon Valley, and San Diego bio clusters in the future." Before attending the event, Won had met with Korean experts that are serving key roles such as IND, NDA, and BLA reviews at the FDA and NIH in Washington DC on the 10th. Over 250 known Korean experts and 1,000 Korean experts are known to be working in the FDA and NIH.. On the same day, Won had also met with Korean-American Professional Association in Life Sciences (KAPAL) executives including its President Byung Ha Lee to discuss ways to support the Korean companies’ entry into the US. The two associations agreed to discuss specific measures for cooperation in the second half of the year. On the 13th, Won met with executives of Korean American Society in Biotech and Pharmaceuticals (KASBP) in San Diego to discuss measures for cooperation in the Life Sciences. As such, the chairman had met with Korean-Americans that are playing key roles in sectors related to the US pharmaceutical and bio-industry during his visit to the US. He also met with Perry L. Fri, Executive Vice President of the US Healthcare Distribution Alliance (HDA), to work for KPBMA to join the HDA. HDA represents US drug distributors and has 35 distributors and 125 manufacturers as corporate members. KPBMA’s membership in HDA is expected to allow domestic companies to participate in education and training programs in the US distribution market. Won said, “In order for the Korean biopharmaceutical industry to go beyond the domestic market and confidently compete on its own in the global market, it must first actively interact with key US pharmaceutical bio clusters, including those in Boston and San Diego."
- Policy
- BA-linked listed drugs are about to be re-evaluated
- by Lee, Tak-Sun Jun 20, 2022 06:03am
- Aseptic formulations will be included in the re-evaluation of the registered drug for BA test from October With the re-evaluation of listed drugs subject to the BA test scheduled to begin in October, attention is being reimbursed to whether some procedural problems will be resolved in advance. The MOHW announced that it would directly conduct BA tests and re-evaluate the price of listed drugs in July 2023 after a three-year grace period. Accordingly, the HIRA will receive data from pharmaceutical companies to prove whether they meet the standard requirements from October to February next year. The question is whether the item will be able to submit related data by the deadline as it has expanded to the aseptic formulation for BA test since October this year. The HIRA plans to consult with the MFDS on necessary measures such as the selection of control drugs for data submission. According to the industry on the 16th, the HIRA will hold a briefing session from 1:30 p.m. on the 22nd at the White Veil located in Seocho-gu, Seoul. It is expected that the number of pharmaceutical companies related to the re-evaluation of the listed drug, which is a face-to-face explanation circuit that takes place for the first time in a long time, will exceed the capacity of the place. The HIRA plans to re-evaluate listed drugs with the aim of applying them in July 2023 as scheduled. Accordingly, pharmaceutical companies are requesting to submit data to prove whether they meet the standard requirements from October to February next year. The core of the data is whether to prove equivalence through BA and others. Most of the requirements for using registered raw materials drugs are expected to be met. To this end, pharmaceutical companies have conducted BA tests by converting consigned manufactured items that have not undergone BA tests into their own production items. The problem is that the drugs will also be subject to the BA test from October, when the data is submitted. The health authorities say these aseptic drugs are subject to re-evaluation of drug prices. After October, the equivalence must be demonstrated through the BA test for aseptic drugs such as injections or the chemical equivalence test that replaces them. The problem is that comparators for tests will not be announced until after October. The pharmaceutical industry believes that it may be difficult to submit data by February next year if the process of selecting a contrast agent is delayed. An official from a pharmaceutical company pointed out, "It is unlikely that companies with many items will be able to manage their schedules," adding, "Aseptic drugs subject to BA tests in October need to extend the deadline for submitting data or hurry to announce control drugs." The MFDS is aware of this. Accordingly, the government plans to apply for and announce the control group drug from time to time, and improve the recognition process. At a meeting with the Korea Special Press Association on the 14th, Kim Ae-ryeon, head of the HIRA drug management office, said, "There is a need for consultation with the MFDS regarding the designation of contrast agents." In March, the HIRA unveiled 3,372 product groups of control drugs and first-time registered products that are excluded from revaluation among 33,618 listed items. As a result, it is expected that items subject to re-evaluation, including aseptic drugs, will be clearly disclosed at the briefing session on the 22nd.
