Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects

Kuribayashi, Ryosuke; Matsuhama, Maki; Mikami, Katsuhiro

doi:10.1208/s12248-015-9777-x

Cited by 27 publications

(24 citation statements)

References 2 publications

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“…The 20 % trimmed mean, which was defined as the mean after discarding samples at the high and low end, was used to evaluate the difference between L-BPA and [ 19 F]-L-FBPA in order to improve non-normality and skew in population distribution in this study. Time courses of the boron compounds in blood and tissues were defined as bioequivalent if the 90 % confidence intervals for the ratios of the average values of parameters fall within the acceptance limits of 0.80–1.25 for the maximum concentration and areas under the blood boron concentration curve (AUC) [18]. …”

Section: Methodsmentioning

confidence: 99%

Comparison of the pharmacokinetics between L-BPA and L-FBPA using the same administration dose and protocol: a validation study for the theranostic approach using [18F]-L-FBPA positron emission tomography in boron neutron capture therapy

et al. 2016

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BackgroundBoron neutron capture therapy (BNCT) is a cellular-level particle radiation therapy that combines the selective delivery of boron compounds to tumour tissue with neutron irradiation. L-p-Boronophenylalanine (L-BPA) is a boron compound now widely used in clinical situations. Determination of the boron distribution is required for successful BNCT prior to neutron irradiation. Thus, positron emission tomography with [18F]-L-FBPA, an 18F-labelled radiopharmaceutical analogue of L-BPA, was developed. However, several differences between L-BPA and [18F]-L-FBPA have been highlighted, including the different injection doses and administration protocols. The purpose of this study was to clarify the equivalence between L-BPA and [19F]-L-FBPA as alternatives to [18F]-L-FBPA.MethodsSCC-VII was subcutaneously inoculated into the legs of C3H/He mice. The same dose of L-BPA or [19F]-L-FBPA was subcutaneously injected. The time courses of the boron concentrations in blood, tumour tissue, and normal tissue were compared between the groups. Next, we administered the therapeutic dose of L-BPA or the same dose of [19F]-L-FBPA by continuous infusion and compared the effects of the administration protocol on boron accumulation in tissues.ResultsThere were no differences between L-BPA and [19F]-L-FBPA in the transition of boron concentrations in blood, tumour tissue, and normal tissue using the same administration protocol. However, the normal tissue to blood ratio of the boron concentrations in the continuous-infusion group was lower than that in the subcutaneous injection group.ConclusionsNo difference was noted in the time course of the boron concentrations in tumour tissue and normal tissues between L-BPA and [19F]-L-FBPA. However, the administration protocol had effects on the normal tissue to blood ratio of the boron concentration. In estimating the BNCT dose in normal tissue by positron emission tomography (PET), we should consider the possible overestimation of the normal tissue to blood ratio of the boron concentrations derived from the values measured by PET on dose calculation.Electronic supplementary materialThe online version of this article (doi:10.1186/s12885-016-2913-x) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

Comparison of the pharmacokinetics between L-BPA and L-FBPA using the same administration dose and protocol: a validation study for the theranostic approach using [18F]-L-FBPA positron emission tomography in boron neutron capture therapy

et al. 2016

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“…The Pharmaceuticals and Medical Devices Agency (PMDA) reviews the equivalence between generic and originator products from the perspective of quality, efficacy, and safety based on documents submitted by the applicants (Kuribayashi et al 2015). The application for new generic drugs includes manufacturing methods, specifications and test methods, stability test data performed in accelerated conditions, as well as BE tests.…”

Section: Review and Approval Of Generic Drugs In Japanmentioning

confidence: 99%

Scientific and regulatory approaches to confirm quality and improve patient perceptions of generic drug products in Japan

et al. 2016

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The rapidly growing medical expense going with aging population in Japan requires the use of generic products derived from off-patent active pharmaceutical ingredients (APIs) formulations to reduce the financial burden for the national health insurance system, while at the same time avoiding undermining the quality of medical care. This article provides an overview of the regulatory approaches available to confirm the quality of generic products and gain their greater acceptance by patients. Among several approaches taken by the Ministry of Health, Labor, and Welfare (MHLW), designing systems to supply higher quality products, and providing scientific information to patients and healthcare professionals are key elements to promote the voluntary choice of the generic product. The revision of bioequivalence guidelines and the enhancement of good manufacturing practice (GMP) requirements facilitate the rational development and manufacturing control of generic formulations. A program termed Quality Reevaluation of Ethical Drugs was carried out from 1997 to 2012 using dissolution tests to avoid any significant bioINequivalence between originators and generic oral formulations. The evaluation of product quality and the assessment of the literature information by the Expert Committee on Quality of Generic Drug Products have provided a unique science-based and patient-focused approach for the distribution of reliable generic products. Some current and future issues regarding complex generic drugs are also discussed.

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“…The target cited in this roadmap was to “increase the market share of generic drugs by 60% or more by March 2018” . In Japan, stakeholders in the medical system are instituting measures and reforms to increase the national and local use of generic drugs . In addition, medical institutions are implementing various programs to achieve this goal…”

Section: Introductionmentioning

confidence: 99%

“…3 In Japan, stakeholders in the medical system are instituting measures and reforms to increase the national and local use of generic drugs. 4 In addition, medical institutions are implementing various programs to achieve this goal. 5 The Japanese medical system is characterized by an excellent public health insurance system, in which out-ofpocket medical fees paid by patients at medical institutions such as hospitals, clinics, and pharmacies only reach 30% of the total medical cost.…”

Section: Introductionmentioning

confidence: 99%

Medical and economic factors influencing generic drug use in the Japanese public health system: Influencing factors in different populations

Tachi

Saito

Esaki

et al. 2018

Health Planning & Management

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Factors influencing generic drug use must be considered when new drug policies are established and initiatives are implemented to promote generic drug use. This study was conducted to elucidate medical and economic factors that influence generic drug use in the Japanese public health system by evaluating the degree of generic drug use via a multivariate analysis. We conducted a retrospective study of medications administered to inpatients at Gifu Municipal Hospital (Japan) from November 1 to 14, 2014. Details of inpatients (age, sex, and type of medical insurance) and the drugs administered (prescribing institution, dispensing pharmacy, price, and class) were assessed. A total of 1409 drugs (original, 639; generic, 770) were analyzed. Multivariate analysis showed significant differences in out-of-pocket medical fees [odds ratio (OR), 0.595], drugs prescribed at Gifu Municipal Hospital (OR, 1.811), drugs prepared at a health insurance pharmacy (OR, 1.541), drugs containing the same active substances as in the generic drugs used at Gifu Municipal Hospital (OR, 3.712), and drugs costing ≥30 yen and containing the same active substance/having the same specifications (OR, 0.516). Drugs prescribed at a large key hospital in the community with high adoption rates of generic drugs, drugs containing the same active substances as the generic drugs adopted by the hospital, and drugs prepared at health insurance pharmacies contributed to a more frequent use of generic drugs. By contrast, out-of-pocket medical fees and being prescribed expensive drugs contributed to the less frequent use of generic drugs.

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Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects

Cited by 27 publications

References 2 publications

Comparison of the pharmacokinetics between L-BPA and L-FBPA using the same administration dose and protocol: a validation study for the theranostic approach using [18F]-L-FBPA positron emission tomography in boron neutron capture therapy

Comparison of the pharmacokinetics between L-BPA and L-FBPA using the same administration dose and protocol: a validation study for the theranostic approach using [18F]-L-FBPA positron emission tomography in boron neutron capture therapy

Scientific and regulatory approaches to confirm quality and improve patient perceptions of generic drug products in Japan

Medical and economic factors influencing generic drug use in the Japanese public health system: Influencing factors in different populations

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