Medical Devices In Japan Research Articles

PHP107 - Economic Evaluation Guideline for Pharmaceuticals and Medical Devices in Japan

PHP107 - Economic Evaluation Guideline for Pharmaceuticals and Medical Devices in Japan

Development of an Official Guideline for the Economic Evaluation of Drugs/Medical Devices in Japan.

In Japan, cost-effectiveness evaluation was implemented on a trial basis from fiscal year 2016. The results will be applied to the future repricing of drugs and medical devices. On the basis of a request from the Central Social Insurance Medical Council (Chuikyo), our research team drafted the official methodological guideline for trial implementation. Here, we report the process of developing and the contents of the official guideline for cost-effectiveness evaluation. The guideline reflects discussions at the Chuikyo subcommittee (e.g., the role of quality-adjusted life-year) and incorporates our academic perspective. Team members generated research questions for each section of the guideline and discussions on these questions were carried out. A draft guideline was prepared and submitted to the Ministry of Health, Labour and Welfare (MHLW), and then to the subcommittee. The draft guideline was revised on the basis of the discussions at the subcommitte, if appropriate. Although the "public health care payer's perspective" is standard in this guideline, other perspectives can be applied as necessary depending on the objective of analysis. On the basis of the discussions at the subcommittee, quality-adjusted life-year will be used as the basic outcome. A discount rate of 2% per annum for costs and outcomes is recommended. The final guideline was officially approved by the Chuikyo general assembly in February 2016. This is the first officially approved guideline for the economic evaluation of drugs and medical devices in Japan. The guideline is expected to improve the quality and comparability of submitted cost-effectiveness data for decision making.

Nationwide Registries Associated with Cardiovascular Medical Devices in Japan

Background: Nationwide medical device registries have the potential to provide real world data for regulatory purposes. The objective of this article is to assess how to develop and manage Nationwide Registries Associated with Cardiovascular Medical Devices (NRACMD). Methods: A questionnaire comprising of 43 items was designed to clarify the quality, characteristics, utility and sustainability of existing NRACMD in Japan. It was then sent to various organizing bodies. Findings: Eight organizations responded to the questionnaire. Three NRACMD were device-specific registries in which the patient was registered when a device was used. The others were procedure-specific registries. Six registries covered more than 95% of target population and two covered 80-95%. Five registries were associated with specialty board certification systems or with physician qualification for using priority devices. No NRACMD was linked to medical re-imbursement. All NRACMD were used for academic purposes related to scientific papers. Two registries were currently in use for all case surveillance under the provision of the Japanese PMD-ACT. One registry provided a historical control group for a device in clinical trial for pre-market application. The analytical output was provided to participating institutions in all registries and to manufacturers in five registries. In terms of registry management sustainability, different funding sources including public funding, funding from institutions or from physicians and manufacturers were used for NRACMD. Accuracy of registered data was verified by institutional site visit and collation of extracted sample data. Interpretation: Japan currently has eight NRACMD are in operation. Although mainly used for academic purposes, there are several examples where data have been used for regulatory purposes and shared with the manufacturers. Cooperation between the academic sector, industry and regulatory bodies is essential for efficient use of NRACMD data.

PHP9 - Medical Devices In Japan – A Market Access Labyrinth?

PHP9 - Medical Devices In Japan – A Market Access Labyrinth?

Patient access to medical devices—what about Japan, the second largest medical device market?

Patients' access to innovative medical devices in Japan still shows the gap between the other countries. The cause of this device gap is researched from the prior published data. We searched the review time of new innovative devices by the Pharmaceuticals and Medical Devices Agency (PMDA) and the submission time lag compared with the US and EU from the prior published data. The average review time was 9.5months and the total time from PMDA to introduction of the device to patients in Japan is almost similar to the US and the four European countries. However, the time lag of the file submission between Japan and the US was 2.42years, on average, between 2001 and 2009. The review time for new innovative medical devices by the PMDA has been improving year after year. On the contrary, the pre-submission delay still exists in Japan.

Analysis of safety reporting requirements during medical device clinical trials in Japan

Regulatory convergence in safety reporting requirements for medical device clinical trials has not yet been achieved. The Global Harmonization Task Force (GHTF) issued new guidance, GHTF/SG5/N5, on this topic in August 2012. First, we compared current reporting requirements for drug and medical devices in Japan with the international guidelines International Conference on Harmonization (ICH)-E2A/E2F and GHTF/SG5/N5. As a result, we confirmed that Japan's expedited reporting requirements are nearly the same for drugs and medical devices and that these requirements are similar to those described in ICH-E2A. We also found that GHTF/SG5/N5 differs from the ICH-E2A in several ways. We sorted these differences into three categories: reportable events, reporting time frame, and definitions of terms. Although there are several equivalent terms between the ICH and GHTF guidelines, the terms Serious Health Threat and Device Deficiency are only defined in GHTF/SG5/N5. The reporting time frame for a Serious Adverse Event is either 10 or 30days for medical devices; expedited reporting is not required according to ICH-E2A, but it is covered in the annual Development Safety Update Report in ICH-E2F. GHTF/SG5/N5 recommends substantially stricter requirements than the current requirements in Japan. Therefore, the Ministry of Health, Labour and Welfare (MHLW) seemed to have prioritized the introduction of consistent definitions of terms while maintaining the current reporting time frame, rather than introducing GHTF guidance as it is. This policy is in accordance with the draft proposal on the revision of safety reporting requirements issued by MHLW in October 2012.

On the 20th Anniversary of Promotion for the Development of Orphan Drugs and Orphan Medical Devices in Japan : Results of the Last 10 Years and Future Challenges

On the 20th Anniversary of Promotion for the Development of Orphan Drugs and Orphan Medical Devices in Japan : Results of the Last 10 Years and Future Challenges

Cytotoxicity of Various Calcium Phosphate Ceramics

The cytotoxicity of five calcium phosphate ceramics, hydroxyapatite (HAp), flouroapatite (FAp), α-tricalcium phosphate (α-TCP), β-tricalcium phosphate (β-TCP) and tetracalcium phosphate (TTCP), was investigated. Based on the guidelines of biological test for medical devices in Japan, a cytotoxicity test of these calcium phosphates was carried out using Chinese hamster V79 lung fibroblasts. The cytotoxic study revealed that FAp and α-TCP showed high cytotoxicities. From various analyses, it was considered that the cytotoxicity of the FAp was due to fluorine ions extracted in a culture medium and the cytotoxicity of α-TCP resulted from a decrease in pH of the medium by the phosphoric acid, which produced by hydrolysis of( the α-TCP.

Price Disparity of Medical Devices in Japan and Overseas

Price Disparity of Medical Devices in Japan and Overseas