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- 2025-12-20 21:52:06
- Policy
- NHIS expands info disclosure about drug pricing negotiations
- by Lee, Tak-Sun Mar 29, 2024 05:53am
- The National Health Insurance Service (NHIS) has decided to expand the scope of information disclosure on its website. Starting in April, the public will have expanded access to information regarding drug pricing negotiations. Information on the types of negotiations of drugs under review and the outcomes of agreements will be made open to the public. According to industry sources on the 28th, the National Health Insurance Service (NHIS), in agreement with the pharmaceutical industry, is expected to expand the disclosure of information related to drug pricing negotiations. Starting from May 2019, people will be able to access information related to drug pricing negotiations by going to ‘NHIS Website-Pre-release Information-Laws/Business Standards-Standards for long-term care reimbursement-Drug pricing negotiations menu.’ The website provides information related to product and pharmaceutical company names of new drugs under drug pricing negotiations, the date of registration, and a list of medicines that concluded drug pricing negotiations. Previously, the NHIS disclosed the information on the website after notifying the pharmaceutical company and following the legal process. Negotiation details and submission documents related to the pharmaceutical company's trade secrets were excluded. However, many have pointed out that such information alone is insufficient to fulfill the rights of citizens and patients to access information. For example, the website currently discloses information on ‘new drugs’ among medicines under drug pricing negotiations. Moreover, the outcomes of the concluded negotiations are not available. Considering the criticism, the NHIS has decided to expand the scope of information disclosure. Starting in April, new drugs, 'medicines exempt from price negotiations,' and 'medicines with expanded indications' that are under negotiation will be disclosed. Additionally, after April, the scope of disclosure will be extended to include medicines subject to negotiation orders from the Ministry of Health and Welfare (MOHW). Furthermore, the NHIS plans to post the agreement outcomes of the drugs that concluded negotiations. Currently, the NHIS does not disclose information on agreement details and only posts medicines that concluded negotiations. There were instances where drugs renewing risk-sharing agreements (RSA) made it onto the list despite failed renegotiations, as initial negotiations were completed. It is anticipated that people can easily find accurate information on medicines under negotiation and agreements reached. “During the meeting, we have notified pharmaceutical companies about the measures to expand information,” an official of the NHIS said. “If pharmaceutical companies with drugs subject to negotiation orders do not raise objections upon receiving notification of disclosure, their details will be posted on the website.”
- Policy
- JW Pharmaceutical agrees on RSA renewal terms for Hemlibra
- by Lee, Tak-Sun Mar 29, 2024 05:53am
- JW Pharmaceutical has reportedly agreed to renew its risk-sharing agreement (RSA) for its hemophilia treatment ‘Hemlibra SC injection’ with the National Health Insurance Service. The company for the leukemia drug ‘Venclexta Tab,’ which was also in the process of negotiating the terms of RSA renewal, is expected to push for a temporary extension of the contract as it failed to reach an agreement by the RSA negotiation deadline. JW Pharmaceutical signed an RSA contract for Hemlibra from May 1, 2020, to April 30 this year. The expenditure cap type of RSA was applied. Hemlibra was unable to reach an agreement in the first round of renewal negotiations but succeeded in reaching an agreement in subsequent negotiations. In May 2020, Hemlibra was first reimbursed for severe hemophilia A antibody patients, and the coverage was extended to patients without antibodies last year. As there are more patients without antibodies than those with antibodies among the 1,700 hemophilia A patients in Korea, the number of insurance claims is expected to increase. Last year, the company's annual sales exceeded KRW 10 billion. With the successful renewal, the RSA contract will continue to be applied for 5 years from May 1 this year to April 30, 2029. On the other hand, discussions on the leukemia drug Venclexta (AbbVie, venetoclax) are having difficulty reaching an agreement within the RSA contract deadline. Venclexta is currently reimbursed as a third-line or greater monotherapy in patients with chronic lymphocytic leukemia (CLL) who have relapsed or are refractory to chemotherapy and B-cell receptor inhibitors, or as a combination therapy in the second-line in patients with chronic lymphocytic leukemia (CLL) who have received at least one prior chemotherapy. The drug’s RSA contract term is from April 1, 2020, through March 31 this year, and was applied the expenditure cap type RSA. In February last year, the drug’s insurance ceiling price was reduced by 12.2% due to the expanded scope of its use. The NHIS and its pharmaceutical company are expected to push for a temporary RSA extension as it would be difficult for the parties to reach an agreement by the end of the RSA term. Sanofi had also signed a temporary term extension agreement for its Dupixent after its contract expired in December last year, and the company successfully renewed its RSA last month.
- Policy
- LG Chem expands its Zemimet SR Tab lineup
- by Lee, Tak-Sun Mar 28, 2024 05:52am
- A new dosage form of LG Chem's diabetes combination drug ‘Zemimet SR Tab (gemigliptin /metformin) will be added to the reimbursement list next month. This is expected to increase prescription options in the field and allow fully personalized prescriptions for the patients. According to industry sources on the 27th, Zemimet SR Tab 25/750 mg will be added to the reimbursement list from April 1. Zemimet SR Tab 25/750 mg is a combination of 25 mg of gemigliptin and 750 mg of metformin. The addition of the 25/750mg dose will bring the total lineup of Zemimet SR Tab to five. This is the most diverse array of options provided among all DPP-4 inhibitor class products. Currently, Zemimet SR 25/500mg, 50/1000mg, 50/500mg, and 25/1000mg are listed in Korea’s reimbursement list. Zemimet SR Tab 25/750 mg will be the first option that provides 750 mg of sustained-release metformin among the combinations. The new product will allow patients to be prescribed various combinations of metformin in different doses depending on their symptoms. For example, patients will be able to receive fully personalized prescriptions that contain low to high-dose metformin- 500, 1000, 1250, 1500, 1750, and 2000 mg – suited to each patient’s specific condition. The product has been designated as an incrementally modified drug combination by the Ministry of Food and Drug Safety in recognition of its improved efficacy and utility. As a result, its drug price has also been incentivized. Since it is an incrementally modified drug combination and LG Chem is an innovative pharmaceutical company, a 68% pricing premium is added to the amount calculated using a set standard (calculating the upper limit of each single drug (or combination drug) by applying a content formula and then summing them). Accordingly, the company received a ceiling price of KRW 428. Last year, LG Chem’s Zemimet SR Tab lineup generated KRW 100.3 billion in outpatient prescriptions (UBIST), surpassing the KRW 100 billion mark for 2 consecutive years. LG Chem and Daewoong Pharmaceutical's joint sales of the drug are analyzed to be creating synergistic effects. LG Chem said, "The new dosage form has significance in that it provides a more targeted, step-by-step drug escalation option for diabetes patients. We will continue to make R&D investments in our Zemiglo product lineup to provide effective diabetes treatment options."
- Policy
- Ruling party will focus on fostering Korea's pharma industry
- by Lee, Jeong-Hwan Mar 27, 2024 06:04am
- The ruling party has adopted a number of policies proposed by domestic pharmaceutical companies and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association as pledges for the 22nd general election, foretelling its plan to concentrate on fostering the domestic pharmaceutical industry. The ruling party's main pledge, which is to create an environment for Korea to make the leap and become a central player in the global pharmaceutical market by expanding government investment in pharmaceutical and bio R&D, supporting the development of blockbuster new drugs, expanding pharmaceutical exports, and expanding incentives for finished pharmaceuticals that use domestic ingredients, largely coincides with the policy proposals that were made by KPBMA. The ruling party’s pledge also met the needs of the pharma-bio sector by adding a policy that strengthens incentives such as expedited review and drug price premiums for developing or manufacturing essential drugs for children or the elderly while establishing a supply management committee to respond to drug supply and demand instability, expanding the items and quantity of drugs in the national stockpile, and supporting manufacturing facilities for essential medicines. This observation was made while comparing between the People Power Party’s 22nd general election policy pledges and the KRPBMA’s policy proposals on the 25th. Specifically, the association requested the government to strengthen the R&D environment to become a global center, expand government R&D investment, support blockbuster drug development, and continue to expand the megafund for blockbuster drugs, and the ruling party responded to the request with such pledges. The plan also included creating a pharma-bio digital innovation ecosystem that incorporates advanced technologies such as AI and big data, expanding drug exports and supporting the development of global big pharmaceutical companies, improving the stability of essential drug supply, and establishing nation-wide measures to realize self-sufficiency of drug substances. The People Power Party will continue to promote and expand a Korean ARPA-H to create blockbuster new drugs and expand tax credits for investments in biotech companies by pharma and bio companies. Also, to improve the success rate of new drug development and commercialization, the government will strengthen support for late phase II-III trials and global expansion and improve the drug price compensation system for domestically developed new drugs. To expand drug exports and support the development of global big pharmaceutical companies, the ruling party also pledged to provide clinical and licensing consulting, distribution network construction and marketing, expand the pool of overseas pharmaceutical experts, and support the establishment of customized export strategies, and establishment of a global medical supply base (contract manufacturing organizations). To stabilize the supply of essential medicines, the government has announced amendments to the Pharmaceutical Affairs Act, including establishing a system to detect drug supply instability and establishing a supply management committee to respond to drug supply instabilities. In addition, the party decided to expand the items and quantity of drugs in the national stockpile, secure adequate inventory for pharmaceutical companies, realize services for the automation of essential drug production and manufacturing facilities, and expand government stockpiles. The drug shortage prevention system and the national essential medicine system will also be linked to support cost preservation. In particular, incentives for the development and manufacturing of essential drugs, especially for pediatric and elderly patients, will be strengthened. Development of essential medicines for pediatric and elderly patients will receive expedited review and separate drug pricing premiums. The government will also support the companies’ development of self-sufficient technologies for essential vaccine ingredients and drugs. Furthermore, a compensation system to reward the innovative value of new drugs will be established. The government will establish an incentive system for the development of new drugs for domestic and foreign pharmaceutical companies, and fully reflect the value of domestic and foreign innovative new drugs in their drug prices. The ruling party's pharma and biotech policy pledges will be implemented in the legislation and government administration depending on the outcome of the 22nd general election.
- Policy
- 'Trajenta-duo' generics as SR tablets…55 approved items
- by Lee, Hye-Kyung Mar 27, 2024 06:04am
- As the patent expiration of 'Trajenta-duo (linagliptin and metformin),' a DPP-4 inhibitor combination therapy for the treatment of diabetes, approaches, approvals of sustained-release formulations are increasing. According to the Ministry of Food and Drug Safety (MFDS), as of March 26th, 55 tablets containing the active ingredients linagliptin and metformin from 27 companies received approvals last year, starting with Daewon Pharmaceutical’s 'Tralitincombi Tab' Out of 55 items approved, 53 items received approvals this year, including 43 items approved in March. Trajenta-duo’s subsequent entry drugs in sustained-release formulation that received approvals in March. Boehringer Ingelheim Korea’s Trajenta-duo, the original drug, received approval on November 15, 2012. Trajenta-duo holds a patent for ‘xanthine and its manufacturing method’ until June 2024. As the patent expiration approaches, domestic pharmaceutical companies have received approvals for generics starting in 2018. The first Trajenta-duo generic was Hanmi Pharm’s 'Linaglo Duo Tab,' a film-coated tablet for rapid action, which is similar to the original. Domestic pharmaceutical companies have received approvals for film-coated tablets of Trajenta-duo after Hanmi Pharm. Until Daewon Pharmaceutical released a sustained-release tablet, 138 products received generic approvals in the form of film-coated tablets. After 'Tralitincombi Tab,' a sustained-release formulation, received approval on October 13, 2023, domestic pharmaceutical companies are releasing Trajenta-duo subsequent entry drugs as sustained-release formulation. Sustained-release tablets regulate the release or discharge mechanism of drugs, allowing them to be released into the body for an extended period after ingestion. This enables the drug to be slowly absorbed in the body for extended efficacy. Therefore, subsequent entry drugs of Trajenta-duo as sustained-release formulations have the advantage of once-daily evening dosing. Boehringer Ingelheim Korea is expanding its product line-up with combination therapies, such as Trajenta-duo and 'Esgliteo (Empagliflozin·linagliptin),' after Trajenta-duo. According to the pharmaceutical market research agency UBIST, Trajenta's outpatient prescription sales amounted to KRW 64.2 billion, and Trajenta-duo's amounted to KRW 68.3 billion, for a total of KRW 130 billion.
- Policy
- MFDS reviews enacting a separate and special law for drugs
- by Lee, Hye-Kyung Mar 26, 2024 06:30am
- The Ministry of Food and Drug Safety (MFDS) is considering enacting a 'special law' to separately manage drug safety management. For this, the MFDS recently launched a call for researchers for the ‘Study for the Analysis of the Legal System of the Pharmaceutical Affairs Act and Review of the Special Act on Drug Safety Management'. The research will be conducted for 7 months from the date the research service is outsourced, and a budget of KRW 50 million will be invested to review reorganizing the legal structure of the ‘Pharmaceutical Affairs Act' in line with the newly changing regulatory environment and to lay the foundation for the enactment of a special law. The 'Pharmaceutical Affairs Act' was enacted in 1953, and has evolved with the development of the pharmaceutical industry, covering a wide range of pharmacist functions and drug licensing, management, and use. The MFDS raised the need for a comprehensive review of the law, explaining, "The law has been partially revised 48 times over the years, limited to only those necessary to introduce new systems and improve operational problems." Therefore, the study will review the legal system and consistency of the law through analysis of the history of the enactment and amendment of the Pharmaceutical Affairs Act, and identify revisions needed under the jurisdiction of MFDS, based on the results. The special law on drug safety management will analyze the domestic pharmaceutical environment and administrative conditions for drug safety management, and conduct demand surveys through industry-wide surveys, etc. The MFDS will conduct a demand survey on major issues and stakeholders' positions on areas that need to be managed by a separate law, the Special Act. In terms of areas requiring drug safety management, the research team will review clinical and licensing, manufacturing and quality control, licensing patent linkage system and data protection system, post-marketing safety management, and the supply system in place for drugs such as essential medicines. The MFDS explained, "Through the study, we will classify, organize, and systematically review the provisions in the Pharmaceutical Affairs Act regarding the areas where special laws need to be enacted. We will also investigate the statutes of special laws enacted in major countries such as the United States and Europe by field with regards to the areas where special laws need to be enacted." In addition, the study will include research on the effective regulatory operation plans for new drugs that cannot be managed by existing laws, such as converged medical products and new drugs utilizing AI. Meanwhile, the MFDS has been enacting and implementing the 'Special Act on Imported Food Safety Management' since February 4, 2016. The Special Act on Imported Food Safety Management aims to improve the consistency and efficiency of the administrative measures posed by unifying the provisions on imported food safety management that were dispersed into the Food Sanitation Act, the Livestock Hygiene Management Act, the Health Functional Food Act, and the Livestock Epidemic Prevention Act. After discussions, the MFDS decided to improve and complement systems already in place in the Food Sanitation Act while maintaining the current status quo, and the scope of regulation was expanded and strengthened by introducing a new registration system for overseas manufacturing companies and establishing new business types such as imported food declaration agencies and internet purchase agencies.
- Policy
- Daewoong joins in competition in the Forxiga generic market
- by Lee, Tak-Sun Mar 26, 2024 06:30am
- Daewoong Pharmaceutical, which had been in charge of the domestic sales and marketing of the original SGLT-2 diabetes drug ‘Forxiga (propanediol hydrate),’ is belatedly entering the generic market through a transfer and acquisition deal. Daewoong had sold Forxiga until January this year. It is analyzed that Daewoong also entered the generic market after AstraZeneca announced its plan to withdraw the drug from the Korean market in the second half of this year. According to the industry on the 5th, Daewoong Pharmaceutical will be listing its Forxiga generic ‘Forxilo Tablet 5mg' at a ceiling price of KRW 262 from April through a transfer and acquisition. Daewoong reportedly acquired Zalozin Tab 5mg from NBK Pharm. The drug is produced by Dongkoo Bio&Pharma upon consignment. Daewoong also acquired the license for Forxilo 10mg in January through an assignment and transfer deal Daewoong did not enter the generic market when Forxiga’s patent expired in April last year because it was selling the original Forxiga Tab at the time. Daewoong has been in charge of domestic sales and marketing of AstraZeneca's Forxiga since March 2018. The company continued to sell Forxiga even after launching its SGLT-2 class drug Envlo (enavogliflozin) in May last year. However, its ties with AstraZeneca ended at the end of the past year with AstraZeneca’s announcement that it will discontinue sales of Forxiga in Korea. In January, Daewoong stopped the distribution and sales of Forxiga, and HK Inno.N took over. Daewoong's entry into the generic market is expected to change the competitive landscape of the market. In particular, generic companies are expected to compete fiercely for the remaining pie once the original withdraws from the domestic market in the second half of the year. Although Daewoong is focusing on promoting its own new drug Envlo, the pharmaceutical industry believes that the power and experience the company had accumulated selling the original Forxiga for 6 years is a force to be reckoned with. Another factor that will affect the market structure is that from April 8, the generic pricing premium applied to innovative Forxiga generic drugs will end. This is because the reduced drug price is likely to reduce promotion costs. However, the pricing premium will be maintained on April 8, 2026, for salt-modified drugs produced by three or fewer generic companies.
- Policy
- Pfizer tops global mkt…Samsung Biologics tops Korean mkt
- by Lee, Hye-Kyung Mar 26, 2024 06:30am
- In 2022, global pharmaceutical giant Pfizer and Korean pharmaceutical giant Samsung Biologics took the top spots in terms of sales, earning KRW 91 billion and KRW 2.437 trillion, respectively. in 2022, according to a new report released by the Korea Health Industry Development Institute, According to the '2023 Health Industry Statistics' recently published by the Korea Health Industry Promotion Institue, sales in the domestic pharmaceutical industry totaled at KRW 37.69 trillion in 2022, up 12.8% year-on-year from KRW 33.42 trillion in the previous year. On the other hand, R&D expenditures the companies invested company granted for each employee totaled at KRW 314.9 billion in the same year, up a mere 6.4% year-on-year. When looking at the sales of the 'Big 5' companies, Pfizer brought in over KRW 91 billion in global pharmaceutical sales and ranked first, followed by AbbVie's KRW 56 billion, then Johnson & Jones, Novartis, and Merck's earnings of KRW 50 billion each. Domestic pharmaceutical companies surpassed the 'KRW 1 trillion club' threshold, with Samsung Biologics posting sales of KRW 2.437 trillion, Celltrion Pharm KRW 1.937 trillion, Yuhan Corp KRW 1.7264 trillion, Chong Kun Dang KRW 1.4723 trillion, and GC Biopharma KRW 1.2449 trillion. In terms of the overall domestic pharmaceutical industry market size, in 2022, the global pharmaceutical industry was valued at USD 1.357 trillion and the domestic pharmaceutical industry was valued at USD 22 billion (KRW 28.905 trillion), showing a -7% difference compared to 2021. The slowdown in growth is expected to continue until 2023. According to the statistics compiled by KHIDI, the global pharmaceutical industry, which has been showing -3% growth ($139.2 billion in the global market and KRW 21 billion in the Korean market) by 2023, will recover its sales from this year and increase market size by 8.3% to reach USD 1.478 trillion and KRW 26 billion, respectively. The top 10 countries in the global pharmaceutical industry in 2022 were the United States with 30.7% (KRW 416 billion), China with 14.4% (USD 196 billion), and Japan with 6.9% ($93 billion), and KHIDI recorded 1.6% ($22 billion), ranking 12th in the world. In 2022, Korea exported $8.083 billion worth of drugs and imported $8.795 billion, with exports going to the U.S. grossing USD 986 million, Japan at USD 772 million, and Germany at USD 773.6 million. In terms of domestic imports, Germany accounted for the most at $1.578 billion, followed by the United States’ USD 1.154 billion and China’s KRW 957 million. Meanwhile, in 2022, a total of 619 domestic drug manufacturers produced a total of 28.953 trillion won (KRW 25.572 trillion from finished drugs and KRW 3.379 trillion in raw materials.) In the domestic pharmaceutical industry, 788.85 people, with 61.4% of them working at workplaces with 300 or more employees.
- Policy
- Sotyktu, Livtencity to be reimb from April
- by Lee, Jeong-Hwan Mar 25, 2024 05:59am
- Sotyktu for plaque psoriasis and Livtencity 200 mg for cytomegalovirus (CMV) infection will be newly listed for reimbursement from the 1st of next month. GLP-1 receptor agonists (GLP-1 RAs, single-agent therapy, and combination therapy) will be reimbursed for use in combination with basal insulin therapy when a patient’s HbA1c level is 7% or higher, even with the use of metformin combination therapy. Reimbursement for the macular degeneration drug Beovu will be extended to cover diabetic macular edema, Rinvoq to moderate-to-severe active ulcerative colitis in adults, Cellcept to connective tissue disease-associated interstitial lung disease, and Soliris to optic neuromyelitis optica spectral disorder (NMOSD). The Ministry of Health and Welfare (MOHW) announced a notice on the partial amendment to the details of the criteria and methods for the application of reimbursement benefits (pharmaceuticals) that contained the changes above on the 22nd. A new reimbursement standard will be set for BMS’s psoriasis drug Sotyktu. Patients with chronic severe plaque psoriasis are eligible. Takeda Pharmaceutical’s Livtencity will be reimbursed for the treatment of cytomegalovirus (CMV) infection and disease following solid organ transplantation or hematopoietic stem cell transplantation. GLP-1 receptor agonists (GLP-1 RAs, single-agent therapy, and combination therapy) will be reimbursed for use in combination with basal insulin therapy when a patient’s HbA1c level is 7% or higher, even with the use of metformin combination therapy. Macular degeneration treatment Beovu will be reimbursed based on the same standards set for anti-VEGF agents in diabetic macular edema (up to 14 total doses per patient, including ranibizumab, faricimab, and aflibercept). Rinvoq’s reimbursement will be extended to cover treatment for adults with moderate-to-severe active ulcerative colitis. For the use of interleukin inhibitors and TNF-α inhibitors criteria set for its use in plaque psoriasis, the previous treatment criteria for the use of MTX or cyclosporine has been expanded to include "DMF administered in patients who were expected to have adverse reactions to MTX or cyclosporine or who are unable to continue treatment due to adverse reactions. Cellcept will be reimbursed for connective tissue disease-related interstitial lung disease, in addition to systemic neuropathy. The serum level criteria that had been applied to fertility medications such as Pergoveris and Luveris will be removed.
- Policy
- Expanded ‘pre-notification for change approval’
- by Lee, Hye-Kyung Mar 25, 2024 05:59am
- The pilot system for ‘pre-notification for pharmaceutical change approval,’ which allows companies to predict the schedule of post-approval changes, will now applied to pharmaceuticals required for reporting production, imports, and supply disruptions. Since December 18th of last year, the Ministry of Food and Drug Safety (MFDS) has been implementing a pilot system for pre-notifying processing post-approval changes. The system was designed to consider the product’s manufacturing and import schedule and process the application within the due date specified by the applying company. Previously, post-approval changes were processed without notification once the MFDS completed the review according to the approval and review procedure. This made it difficult for applying companies to predict the date of change approval. The system has been updated to make the drug approval system flexible and reasonable. Starting this year, the MFDS pilot system for ‘pre-notification for pharmaceutical change approval’ will be expanded to drugs requiring reports of production, imports, and supply disruptions. The pre-notification system for post-approval changes, piloted until December 31st, includes the processing of change approvals for new drugs, orphan drugs, and cutting-edge biomedicines past the legal processing due date. Starting this year, the system will be expanded to include pharmaceuticals requiring reports of production, import, and supply disruptions, in order to ensure a stable domestic supply of pharmaceuticals. The list of pharmaceuticals subject to reporting production, import, and supply disruptions, posted annually by the Health Insurance Review and Assessment Service (HIRA), includes about 2,805 items (excluding duplicates) as of 2023, including anticancer drugs with 1-2 suppliers. Companies that wish to be pre-notified for pharmaceutical change approval can select ‘yes’ to the ‘modification of change date’ when filing an application to the MFDS. When adjustment dates were not specified at the time of application, companies can apply for the system via official letter until seven days before the processing deadline. If a company wishes to request a modification to the post-approval change date, it must specify the date after the legal processing date. For example, if the application's total processing period is 50 days, the company can specify the date within 50 working days of the processing deadline. However, companies cannot shorten the processing duration through this system because it was designed not to affect the existing approval review process. The pre-notification system only applies to cases where the application processing has to be delayed (extended) beyond the original processing deadline due to the drug's manufacturing or import schedule. Modifications to change approval date (extension) can generally be applied to products, except when they fall under one of the following criteria: ▲restrictions to efficacy, method-of-use, and dose that relate to the safety of the product ▲a change in warning labels ▲or when requiring importance and urgency. The MFDS will pilot the system until the end of December this year and decide on formal operation after an evaluation and review of the results. “For pharmaceutical, we receive many requests for simple changes or extension of the deadline for drugs with confirmed approval,” an official from the MFDS stated. “The pre-notification system is an additional administrative procedure designed to aid the industry. So we encourage companies to apply for the system when they need it.”
