• Korean Journal of Clinical Pharmacy
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• v.23 no.2
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• pp.106-113
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• 2013

Background: For Korean pharmaceutical industry to continue to grow, it is requisite to enter the global markets of developed countries. However, the export volume has fallen short of 10% of the gross sales and the industry has only recently warming up to prepare the globalization along with suchlike the Columbus Project. Purpose: This research was conducted to identify the difficulties Korean pharmaceutical companies perceived and to discover the gap in the needs for the government aid the companies have been seeking in the purpose of entering the developed pharmaceutical markets. Method: A survey method was used for this research. Six experts were surveyed and provided comments for the pre-questionnaire. Then, a final questionnaire was developed consisting of 10 items on regulatory-related and another 10 items on non-regulatory-related factors in drug exportation using the Likert scale (1 to 5). The survey sample was 30 Korean companies which have participated in the Columbus Project since 2010. Results: Nineteen (63%) companies responded to the survey. Most companies perceived difficulty (mean = 4.19) over the entire pathway of the regulatory process of global markets. Clinical trials and post-marketing surveillance were remarked as the most difficult barrier to follow the regulatory globalization. Among non-regulatory related factors, marketing, arranging a distribution network, obtaining experts, and projecting a timeline in exportation were brought up as the most difficulty. Conclusion: Especially, cost and language barrier were considered as the main cause producing these difficulties across regulatory and non-regulatory processes and accordingly, securing both long term budget and experts at governmental level was suggested by the domestic pharmaceutical companies.

• Tuberculosis and Respiratory Diseases
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• v.80 no.1
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• pp.52-59
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• 2017

Background: Inhaled indacaterol (Onbrez Breezhaler), a long-acting ${\beta}_2$-agonist, is approved in over 100 countries, including South Korea, as a once-daily bronchodilator for maintenance and treatment of chronic obstructive pulmonary disease (COPD). Here, we present an interim analysis of a post-marketing surveillance study conducted to evaluate the real-world safety and effectiveness of indacaterol in the Korean population. Methods: This was an open-label, observational, prospective study in which COPD patients, who were newly prescribed with indacaterol (150 or $300{\mu}g$), were evaluated for 12 or 24 weeks. Safety was assessed based on the incidence rates of adverse events (AEs) and serious adverse events (SAEs). Effectiveness was evaluated based on physician's assessment by considering changes in symptoms and lung function, if the values of forced expiratory volume in 1 second were available. Results: Safety data were analyzed in 1,016 patients of the 1,043 enrolled COPD patients receiving indacaterol, and 784 patients were included for the effectiveness analysis. AEs were reported in 228 (22.44%) patients, while 98 (9.65%) patients reported SAEs. The COPD condition improved in 348 patients (44.4%), while the condition was maintained in 396 patients (50.5%), and only 40 patients (5.1%) exhibited worsening of ailment as compared with baseline. During the treatment period, 90 patients were hospitalized while nine patients died. All deaths were assessed to be not related to the study drug by the investigator. Conclusion: In real-life clinical practice in South Korea, indacaterol was well tolerated in COPD patients, and can be regarded as an effective option for their maintenance treatment.

• Pediatric Infection and Vaccine
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• v.15 no.1
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• pp.5-11
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• 2008

Primary rotavirus gastroenteritis infection usually occurs in infants under 2 years of age worldwide regardless of level of hygiene, quality of water, food or sanitation or type of behavior. In Korea, the disease mostly occurred in infants under 2 year old, and usually in late fall to early winter with the highest incidence shown in November until early 1990s. However, since then, relatively the age incidence of this infection has increased in children over 2 years old, and it has mainly occurred in late winter to early spring with the highest incidence shown between February and March. And rotavirus gastroenteritis serotypes varied year to year as well as varied by year within the same region in our country. The comparison of severity scores between age groups in Korea showed that severity score was lowest in infants less than 3 months and highest in infants more than 6 months and less than 12 months, and hospitalization period between age groups was longest in infants older than 3 months and less than 3 months and highest in infants more than 6 months and less than 12 months and less than 6 months. In this aspect, rotavirus vaccines should be given to infants less than 2 years of age in whom the incidence of rotavirus gastroenteritis is the highest, and vaccination should be ideally started before 3 months considering hospitalization period and severity of rotavirus gastroenteritis. However, It should be careful for the introduction of new rotavirus vaccine, and the effectiveness of rotavirus vaccines should be assessed by long-term post marketing surveillance. And we guess an multivalent vaccine may be an ideal rotavirus vaccine to prevent primary infection caused by variable rotavirus strains in Korea. In addition, clinical epidemiology studies on rotavirus gastroenteritis which evaluate the age and serotypes related severity should be continuously conducted in various regions.

• Korean Journal of Clinical Pharmacy
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• v.29 no.2
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• pp.71-78
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• 2019

Objective: This study aimed to provide efficacy and safety information on the use of erenumab for prevention of episodic and chronic migraines. Methods: The keywords "Erenumab and migraine" were used to search the PubMed database to then compile efficacy and safety data for erenumab. Data from relevant Phase 2 and Phase 3 clinical trials were analyzed, using RevMan for statistical analysis. Results: Three clinical trials (one Phase 2 and two Phase 3 studies) were retrieved. All three trials used the same primary endpoint (change from baseline in monthly migraine days (CBMD)) to evaluate efficacy and safety of erenumab use for prevention of episodic and chronic migraines. Subcutaneous doses of erenumab (70 or 140 mg) were administered monthly in each trial, for 3 months (Studies 2, and 3) or 6 months (Study 1). The mean differences in CBMD in the 70 mg and 140 mg erenumab arms were -1.36 and -1.98, respectively, compared to that in the placebo arm. Some adverse events, such as nasopharyngitis and upper respiratory tract infection, were reported, but no differences in safety between erenumab and placebo were found to be significant. Conclusions: Erenumab showed superior efficacy in prevention of migraines compared to placebo. However, additional information regarding the long-term safety of erenumab should be collected. Therefore, post-marketing surveillance for adverse events is needed.

• The Journal of the Convergence on Culture Technology
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• v.8 no.5
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• pp.29-37
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• 2022

MDR, a new European medical device regulation newly enacted in 2017, requires that medical device products that have received CE conformity certification through MDD be re-certified by May 2024 in line with the new CE MDR regulation. The new MDR requires more stringent medical device clinical evaluation and clinical investigation than the previous MDD required, and also require the submission of documented post-marketing surveillance data. Korean medical device makers also need to meet the new MDR requirements and obtain conformity certification, but the industry is still confused because they do not understand the new regulations thoroughly. In this study, medical device regulations in Korea, the United States, and Europe are compared, and the European MDR is further compared with the previous European Medical Device Directive MDD to help understand the requirements of the new European Medical Device Act.

• Pediatric Infection and Vaccine
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• v.20 no.3
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• pp.139-146
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• 2013

Objective: As per the requirement of Korean Food and Drug Administration, this post-marketing surveillance was conducted in Korea to evaluate the safety and reactogenicity of Poliorix$^{TM}$ following its introduction in 2006. Methods: In this open, multicenter study, the vaccine was administered as per the current practice of Korean doctors and in reference to the guidebook by the Korean Pediatric Society and as indicated in the Korean label which was as follows - for primary vaccination three doses were given to infants at ages 2, 4 and 6 months whereas, for the booster dose a single dose was given to children aged 4-6 years. Safety data during this six year surveillance was collected using diary cards which were distributed to the parents to record adverse events. Results: A total of 639 subjects were enrolled into the study. Of these, 617 subjects and 22 subjects received the vaccine as a primary and booster dose, respectively. At least one unsolicited symptom was reported in 11.4% (73/639) of the subjects during the 7-day follow-up period; upper respiratory tract infection (2.5%;16/639) was the most frequently reported unsolicited symptom. One subject reported at least one unsolicited symptom (gastroenteritis) of grade 3 intensity within the 31-day post-vaccination period. Approximately 1.7% (11/639) of subjects reported 13 serious adverse events (SAEs). All SAEs were resolved by the end of the study. Conclusion: In Korea, primary and booster vaccination with Poliorix$^{TM}$ was well-tolerated in healthy subjects when administered according to the prescribing information as part of routine clinical practice.

• The Korean Society of Law and Medicine
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• v.21 no.3
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• pp.77-116
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• 2020

The use of drugs that reflect the experiences and achievements of modern science has given human being the benefits of treating diseases and improving health conditions. However, in addition to the benefits of those, medicines have inherently inevitable adverse reactions. Many countries are taking measures such as market entry regulations or post-marketing surveillance to minimize damage caused by drug side effects, but the occurrence of side effects cannot be eliminated. Although the damage is force majeure, in some cases, the doctor who prescribed the drug or the pharmacist who administered the drug may have to compensate for the damage. The liability depends on whether the side effects were known in advance, the type of medicine, etc. On the other hand, in some cases, drug manufacturer may have to take liability for the side effect itself. As it is not easy for victims to be compensated for damages in those cases, many countries, including Korea, are setting to protect victims through the Product Liability Act. Drugs are also one of the product, so liability set by the Product Liability Act may apply. Even before the enactment and enforcement of the Product Liability Act, damage caused by drug has occurred. To resolve them, precedents have developed case law, which have many similarities with the Product Liability Act, but also have differences. Damage caused by drug manufactured prior to the enforcement of the Product Liability Act may occur in the future. In this context, the legal principles of the case laws will remain valid and be applied. This is an important reason to review the case law of precedents.