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- 2025-12-26 13:07:29
- Policy
- Only one case of non-tumor initial human administration test
- by Lee, Tak-Sun Dec 20, 2019 06:35am
- Among the clinical trials conducted by multinational pharmaceutical companies in Korea, the first human-administered trial was found to be very rare. According to the Korea Clinical Trial White Paper No. 2 published by the Korea National Enterprise for Clinical Trials (CEO Dong-Hyun Ji, KoNECT) on the 18th, there was only one initial human dosing study in non-tumor fields conducted by multinational pharmaceutical companies from 2016 to 2018. The initial human administration study mainly examines the pharmacological effects and side effects of the human body in healthy adults and determines the tolerated dose. It will also identify pharmacokinetic properties. Proceeding with the patient will explore the potential for effectiveness. Clinical progress and analysis is known to be difficult because it determines the direction of successful commercialization of the drug. Activation of Phase I clinical trials by multinational pharmaceuticals, such as the first human administration trial, is essential for raising the domestic clinical level. In addition, it means that commercialization of new drug development will be carried out from the beginning, which is related to the activation of new drug development in Korea. In the case of new drugs developed in Korea, Phase I clinical trials are often conducted overseas. Table 63. Characteristics of Phase 1 Clinical Trials in Non-tumor Fields (206-2018) In the first phase clinical trials of the tumor field, the first human trial of multinational pharmaceutical companies was rare. The white paper explained that at least six were approved. During the same period, Korean pharmaceutical companies undertook 28 trials of the first human trial in the non-tumoral field. This is only 7.9% of all phase I nonclinical trials. Even if it was not the first human trial, multinational pharmaceutical companies (including multinational CROs) accounted for only 4.5% of the phase I clinical trials. Tumor field was 23.3%. However, the share of multinational pharmaceutical companies increase as they move to Phase II clinical trials. In Phase II, multinational drug makers accounted for 32.3% of non-tumors and 33.6% of tumors.
- Policy
- Parliament pushes for drug revocation bill w/o sales record
- by Lee, Jeong-Hwan Dec 20, 2019 06:35am
- A bill was proposed by the National Assembly to prohibit the renewal of drug items without sales records. The legislative goal is to minimize damage to Valsartan-Ranitidine impurities (NDMA) by eliminating drugs that some pharmaceutical companies produce only the minimum quantity and do not sell in order to update the product, which is a prerequisite for permit maintenance. On the 18th, Sang-hee Kim, a memeber of the National Assembly's Health and Welfare Commission announced that she proposed a partial amendment to the pharmaceutical affairs law. Current legislation requires the renewal of a drug license and declaration in order to sell the drug after the expiration of the drug product approval and the validity date. Drugs that are not manufactured or imported during the expiration date cannot be renewed Recently, NDMA has been detected in drugs such as high blood pressure treatment, Valsartan and antacid drugs, Ranitidine. It was pointed out that a drug that manufactured and imported only a minimum quantity for the item update and was not actually sold or distributed. Representative Sang-hee Kim pointed out the problem that the drug can be renewed without submitting the data. When renewing a drug product, it is necessary to submit data such as side effects collected during the expiration date, quality control and improvement measures to confirm safety and effectiveness. Drugs that are not actually sold can be renewed without submitting data. In order to protect the public health, it is necessary to check the status of safety and quality control of all medicines when updating drug products. Representative Kim said, “It is the core of the bill to restrict the renewal of product licenses and notifications for drugs that are not manufactured or sold within the validity period, I will build a foundation to provide safe and effective medicines”.
- Policy
- Swiss companies to benefit from mutual recognition of GMP
- by Lee, Tak-Sun Dec 19, 2019 11:20pm
- A mutual recognition agreement of Good Manufacturing Practice (GMP) with Swiss pharmaceutical regulator Swissmedic would not only invigorate pharmaceutical trade between two countries, but also it is expected to be a meaningful step towards Korea earning recognition of international level of regulation. The mutual GMP recognition agreement would bring significant influence on Korea, as Switzerland is one of A7 countries, which the Korean regulators refer to when deciding new drug pricing, and is also a pharmaceutical powerhouse with headquarters of Novartis, Roche and other major global companies. Korea’s Ministry of Food and Drug Safety (MFDS) announced on Dec. 18, it would be officially signing a Mutual Recognition Agreement (MRA) of GMP with Swissmedic. When the agreement comes in effect, GMP evaluation when applying for new drug approval in either country would be exempted. GMP certificate from either country would be validated in the other country. As a result, local due diligence, written review and other review procedures would be eliminated and ultimately accelerate the drug approval process. Korean pharmaceutical and bio companies would be able to reduce commercialization preparation period in Switzerland with the mutually recognized GMP certificate. The same goes for Swiss pharmaceutical and bio companies. Their new drug would be exempted from MFDS’ GMP evaluation. Actually, Korea has more drugs importing from Switzerland than exporting to them. Pharmaceutical powerhouse Switzerland houses major global pharmaceutical companies like Novartis and Roche. To this date, MFDS reviewers paid a visit to the local manufacturing plant and conducted GMP due diligence when reviewing Swiss pharmaceutical products. The MRA would drop GMP due diligence and other written review, which would reduce Swiss drug’s approval period in Korea by three to four months. It would be remarkable benefit for Novartis, Roche and other Swiss pharmaceutical companies. Targeting the Korean market, the Swiss companies now have the upper hand against other U.S. or European pharmaceutical companies. Although Korea exports less volume of pharmaceutical products to Switzerland, the intangible value generated from the MRA would shine through for the Korean industry later in the future. Signing of the MRA could mean that such a major pharmaceutical powerhouse recognizes Korea’s regulatory capability. The GMP recognition agreement MFDS signed with Ecuador in 2014 only applies to Korean drugs applying for approval in Ecuador, and it does not apply on Ecuadorian drug in Korea. MRA can only be signed by two countries when their regulatory standards are mutually recognized as equivalent level. Accordingly the signing of the MRA proves Switzerland also thinks highly of Korean regulatory standards. This could be favorable for Korea when negotiating with other countries. MFDS is currently seeking for opportunities to negotiate MRA on GMP with countries that have joined Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (PIC/s). Increasing number of countries with high faith in Korean regulatory system would simplify local new drug approval process for Korean-made drugs and also positively influence the industry’s business. MFDS official explained, “As Switzerland is not part of EU, it had an independent regulation apart from EMA and Korean companies had to go through another set of review process. The country is a home of global companies like Roche and Novartis, and CMO companies like Lonza. Korea has been recognizing Switzerland as one of A7 external reference pricing countries with their outstanding review capability that other advanced countries also approve of”. “MRA with Switzerland on GMP would be an opportunity for Korea to raise awareness of Korea’s trustworthy regulatory capability to other countries”, the official added.
- Policy
- Mandatory evaluation of MFDS when using all off label drugs
- by Lee, Jeong-Hwan Dec 19, 2019 06:35am
- A bill is piloted to require government assessments when using 'off-labeled drugs' in patients that go beyond the indications that have been proven in clinical trials, which are phases of drug marketing. Representative Sang-hee Kim of the National Assembly on Health and Welfare on the 18th proposed the partial revision of the Pharmaceutical laws and regulations. Off-labeled use of current drugs differs from individual use procedures, such as those subject to reimbursed benefits and non-reimbursed, over-the-counter and anticancer drugs. Representative Sang-hee Kim said that the pharmaceutical industry is passive in research and development of medicines that meet the medical needs such as rare and severe diseases, children, and pregnant women, and encourages the use of off-label. It is pointed out that the use of off-labeled drugs with different efficacy, effect, indications, and dosage is not frequently recognized by the Ministry of Food and Drug Safety, which is a drug approval authority. Representative Kim criticized that MFDS conducts off-label use evaluation only for non-reimbursed generic drugs according to the Ministry of Health and Welfare, so systematic safety management of over-licensed drugs is not possible. Representative Kim said, “To prevent this, we need to establish a legal basis for the safety and effectiveness evaluation of MFDS for all use of off-label drugs, we will promote public safety by establishing a systematic evaluation environment for non-permission use”.
- Policy
- First Samsca generic submits approval application
- by Lee, Tak-Sun Dec 19, 2019 06:34am
- 오츠카 The first generic to follow Korea Otsuka Pharmaceutical’s Samsca (tolvaptan), indicated for treating euvolemic hyponatremia, has submitted an approval application to Korean Ministry of Food and Drug Safety (MFDS). The industry believes Myung In Pharma would be the one to grab the approval as it has been challenging the patent and developing the follow-on drug. According to MFDS on Dec. 17, a tolvaptan-containing drug submitted an application for approval. The drug in 15 mg dose is administered once-daily to treat patients with hyponatremia. As stated by the Drug Approval-Patent Linkage system, MFDS notified Otsuka, the patentee, about the submitted application. Otsuka’s Samsca is protected by a patent on solid preparation and its manufacturing method of the medicine including bezoazepine, which is to be expired on June 20, 2028. In last May, Myung In Pharma evaded infringement of Samsca’s drug patent with Intellectual Property Trial and Appeal Board’s ruling. The company filed a defensive confirmation trial for the scope of a right, which then was affirmed. And in the same month, the company’s bioequivalence test protocol was cleared. Based on the clues, the industry is convinced Myung In Pharma has probably applied for the approval. The original Samsca is the first-and-only hyponatremia treatment approved by MFDS in September 2011. Hyponatremia is an electrolyte-associated adverse event commonly found in hospitalized patient, which can cause serious neurologic complications. Before Samsca was available, intravenous fluid with high concentration of sodium was given to the patients, but it did not treat the cause. Recently, Samsca was granted with reimbursement approval on indication for treating patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). If Myung In Pharma snatches the first generic title in the market, it is expected to earn a significant commercial success with minimum competitors.
- Policy
- The MFDS plans to collect & test Metformin
- by Lee, Tak-Sun Dec 18, 2019 06:24am
- The Ministry of Food and Drug Safety (the Minister, Eui-Kyung Lee) has decided to collect and inspect commercial distribution items to investigate impurities on Metformin. As a result, the MFDS is preparing a test method with a goal within the year and is conducting a raw material system investigation for the preliminary safety management. The MFDS said it is conducting an impurity investigation on Metformin on the 16th. Prior to this, the Singapore Health Sciences Agency (HSA) announced that it detected and recovered trace amounts of 'N-nitrosodimethylamine (NDMA)' in three out of 46 Metformin-containing products. NDMA is a Group 2A human carcinogen suspected by the World Health Organization (WHO) International Cancer Institute (IARC). The MFDS confirmed that the same products as those recovered in Singapore were not imported in Korea. However, raw materials from the same manufactory used in the medicine are said to have come from Korea. However, even if the raw material of the same manufactory lot may be different because there is not necessarily the risk of problems. First, the MFDS is conducting a systematic investigation of the source (import source) of the use of Metformin-containing medicines in advance of safety management. It also plans to establish a test method for NDMA in metformin within the year. After the test method is established, Metformin raw materials and drug products will be collected and tested as soon as possible. An official from the MFDS said, "We will start collecting products this month and carry out inspections from January next year". Investigations are expected to be conducted first with products that are the same manufacturer as the raw material for products recovered in Singapore. It will be considered whether to expand the survey. This is because the test subjects are so large that Metformin is allowed in 640 items in Korea. An official from the MFDS said, “We will carry out test tests promptly, and we are working closely with regulatory agencies such as the European EMA, the US FDA, and the Japanese PMDA to exchange related information such as the cause of occurrence”. In addition, the MFDS and the Korean Diabetes Association, Metformin is a diabetic drug, and continuous medication is very important for the treatment of diseases. Patients taking Metformin-containing medicines were advised not to stop taking it without consulting their doctor or pharmacist. In the future, if there is a test result exceeding the acceptance criteria, it will immediately notify the health professionals and the public, including medical and pharmacists.
- Policy
- Why did MFDS release its Metformin self-investigation plan?
- by Lee, Tak-Sun Dec 17, 2019 07:20am
- The Ministry of Food and Drug Safety said on the 16th that it is directly investigating the drug 'Metformin', a drug that has been recovered and detected by carcinogen NDMA (N-nitrosodimethylamine) in Singapore. It was the first time that the MFDS announced its own investigation since the Singapore Health and Science Agency announced the recovery of three Metformin items. The MFDS has said through media coverage that it is investigating the domestic inflow of raw materials used in Singapore's products in question, but the MFDS kept silent about collection and inspection plans for domestic distribution items. Let’s learn about the background of MFDS' silence and the release of Metformin's own investigation through a press release. Public opinion has changed, ordered from the Diabetes Association The MFDS released a press release on the 16th, is currently preparing a test method for Metformin formulations, and is conducting a systematic survey on domestic distribution items to identify the source of raw materials. In addition, as soon as the test method was prepared, the MFDS added that they plans to collect and inspect domestic distribution items. In fact, the MFDS has not said that they will not directly conduct an investigation into Metformin's impurities. Nor did they instruct the vendor to do the test autonomously. However, as part of the follow-up measures of Ranitidine and Nizatidine, the press release and public hearings revealed that companies should directly investigate raw materials and finished products that are likely to cause impurities. Some companies have conducted their own tests. Some expressed suspicion that the MFDS was not actively involved in collection and inspection, as opposed to when NDMA problems were raised in Valsartan or Ranitidine. Indeed, the Korean Diabetes Association, which consists of domestic diabetic doctors on the 13th, said, "There is no official announcement whether the raw materials of the company in question were imported to Korea". The Society stressed that the MFDS should address the public's concerns through direct investigations. The Diabetes Society's point was enough to raise suspicion that the MFDS remained a mere spectator. An official from the industry said, “If the MFDS conducted a survey of domestic distribution items based on Singapore collection only when the impurity risks of Metformin preparations were not verified, it would have increased public anxiety, however, on the contrary, it seems to have disclosed its own research plan immediately after pointing out that it should actively take the measures to resolve the public unrest”. Raw material check… increased need for recovery investigation Although it did not appear in the press release distributed on the 16th, it is confirmed that the drug substance imported from Singapore is met with the same drug substance as the Metformin preparation recovered in Singapore. Earlier, the MFDS said that there was no inflow of finished products in Korea, and that it was checking whether the drug substance was imported. The fact that the MFDS conducted a systematic investigation to identify drug substance manufacturers for Metformin ingredients and finished drugs in Korea was influenced by the inflow of ingredients from the same factories as those of Singapore. Therefore, the necessity of checking the raw materials through the systematic investigation, collecting them directly, and increasing the need for self-investigation was increased. However, an official of the MFDS said, “Even if the raw materials are the same, there is no risk because the production lot (process) may be different”. also added “there is no intention to select the raw materials in question because the systematic survey is to investigate the source of all distribution items”. However, it is highly likely that the target of the first collection, inspection planned by MFDS will be the same raw material manufacturer as the recalled product in Singapore. If the risk is identified, the collection and inspection can be extended, otherwise the case can be closed. The MFDS also recognizes the limitation of recovery and investigation of all items. Metformin is a multi-frequency prescription drug that is used as the first-line drug for type 2 diabetes treatment, and this is because 640 domestic licensed items are available. The MFDS expects to investigate domestic distribution items as early as January next year. As such, collection of some distribution items is highly likely to begin this month. The MFDS' full-fledged investigation does not increase the risk of Metformin. The MFDS said in a press release on the 16th. that, among other things, patients taking Metformin-containing medicines should not stop taking it without consulting their MDs or pharmacists.
- Policy
- Exclusivity for Galvus’ generics applied Aug 2021
- by Lee, Tak-Sun Dec 13, 2019 11:00pm
- Galvus by NovartisAs expected, Ahn-Gook Pharmaceutical obtained the approval for exclusivity for generic product as Galvus (Vildagliptin), a diabetes treatment of DPP-4. The MFDS designated the priority sale items for Ahn-Gook Vildagliptin Tablet 50mg of Ahn-Gook Pharmaceutical and Ahn-Gook Newpharrm Vilagliptin Tablet 50mg of its subsidiary Ahn-Gook Newpharm. As a result, it is not possible to sell any of the late-release drugs, except for Ahn-gook Pharm., From August 30 2021 to May 29 2022. Ahn-Gook Pharmaceuticals first filed a trial for extended period of invalidity on Galvus' patent for the first time as a domestic company on July 14 2017. This succeeded in invalidating the extended duration 187 of the material patent. The company received the affirmed decision. It is the first generic item to submit a permit application in last March. The company obtained a product license last month. Three conditions required for the right of exclusivity for generic product : the first patent challenge, the successful patent challenge, and the first application for permission and The company achieved all 3 conditions perfectly. The ban on late drug sales from August 30 2021. This is because Ahn-Gook advanced 187 during Galvus' patent expiration date, which is expected to expire on March 4, 2022 On the other hand, late-runners outside of Ahn-Gook are trying to circumvent the sale ban by Ahn-Gook’s right of exclusivity for generic product. Hanmi pharmaceticals has a strong chance of obtaining a separate right to sell salt-modified drugs and is currently applying for a permit. Korea United Pharm Inc , Kolmar Korea, and Alvogen Korea have also begun developing late-on drugs.
- Policy
- Galvus SR developed by Alvogen, 100mg once daily
- by Lee, Tak-Sun Dec 13, 2019 06:34am
- Galvus by NovartisAlvogen Korea is trying to differentiate itself from domestic competitors by developing Galvus SR tablets. The drug Alvogen develops is a sustained-release multi-layered tablet containing Vilagliptin, which is known to be taken once a day, unlike the original. The MFDS approved Alvogen Vildagliptin SR tablet’s clinical protocols on the 27th of last month. It proceeds to compare the pharmacokinetics and safety of the original drug, Galvus and to evaluate the pharmacokinetics after food intake. According to the latest detailed plan, clinical trials will be conducted from January to February next year for a total of 42 healthy adults. The control group is taking 50 mg of Galvus tablet twice a day, and the test group is taking 100 mg of Vildagliptin sustained-release tablet once a day. In the second test group, after taking a high-fat meal, take 100 mg of Vildagliptin sustained-release tablet and compare and analyze the pharmacokinetic characteristics. The original Galvus is 50mg. Alvogen Korea is trying to differentiate itself from domestic competitors by developing Galvus sustained-release tablets. The drug Alvogen develops is a sustained-release multi-layered tablet containing Vilagliptin, which is known to be taken once a day, unlike the original. The original Galvus is 50mg twice daily if needed. On the other hand, Alvogen's product is taken once a day, which seems to improve convenience. Vildaliptin is currently approved by Original Novartis and Generics Ahn-Gook Pharmaceutical. If Alvogen succeeds in commercializing Vildagliptin sustained-release tablets, it will be able to enter the market regardless of Ahn-Gook's right to exclusivity for generic product. This is because the main ingredient is the same, but This is not the case with exclusivity for generic product. However, as Galvus' material patents last until March 4, 2022, they will not be able to enter the market early unless they are neutralized. It is noteworthy which strategy Alvogen will enter the market.
- Policy
- 'WHO PQ' for 3 domestic vaccines, including Skycellflu
- by Lee, Jeong-Hwan Dec 12, 2019 10:52pm
- Three domestic vaccines have secured international procurement bidding rights, obtaining WHO Prequalification (PQ). SK Bioscience's Sky Cellflu Multi inj, Sky Cellflu inj, and Sky Varicella inj are the main characters. On the 11th, the Ministry of Food and Drug Safety (The Minister, Eui-Kyung Lee) said, "The domestic vaccines passed the WHO PQ, allowing participation in international procurement bidding". WHO PQ is a system for evaluating safety and efficacy for the supply of medicines, including vaccines, to developing countries through international procurement. MFDS has systematically supported WHO certification of domestic vaccines and biosimilar products by establishing a cooperative system with WHO as well as customized consultation services from companies and public-private experts. Specifically, ▲technical consultation on 1: 1 expert consultation team, ▲on-site technical advisory on certificated companies, ▲WHO PQ information sharing seminar, and ▲WHO PQ information book publication. Since 1996, 'Euvax B inj.' is a domestic product that has received WHO Prequalification. There are a total of 16 products by this year. The MFDS said, “We will actively support the activities of companies to enhance the export competitiveness of domestic biopharmaceuticals such as WHO Prequalification, in addition to running customized counseling services, we will continue to publish on-site technical consultations for WHO PQ survey experts and WHO PQ question and answer collections next year”.
