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Quickly access the latest reviews to compare actual user opinions and ratings. SoundCloud is a music and podcast streaming platform that lets you listen to millions of songs from around the world, or upload your own. Designed to replace clunky, old scheduling spreadsheets, Resource Guru helps managers get organized fast. Some examples of foreign regulatory actions for which the MAH is required to notify to Health Canada, include:. Information subject to the reporting requirements be reported to the Minster through an online Health Canada form within 72 hrs after becoming aware of the foreign regulatory action.

For more information on notifying Health Canada of foreign regulatory actions and for examples of the foreign regulatory actions to be reported, please see the Health Canada guidance document cited in the reference section below. Health Canada recently informed stakeholders, in particular manufacturers and importers of medical devices, of its intent to propose regulatory changes to strengthen post-market surveillance and risk management of medical devices in Canada.

The proposed regulatory reforms will involve amendments to the Medical Devices Regulations. The goal of this initiative is to improve the availability, access, and quality of information available on medical devices in Canada. The GMDN is a system of internationally agreed descriptors used to identify medical devices. The purpose of the nomenclature is to facilitate the exchange of medical device information in support of patient safety. Specifically, the nomenclature is used for data exchange between manufacturers, regulators and health authorities; exchange of post-market vigilance information; supporting inventory controls in hospitals; and purchasing and supply chain management.

The GMDN database is a constantly evolving database that currently consists of 23, active terms covering all major technologies and intended uses. By adopting the GMDN, Health Canada has taken another step toward fulfilling its mission to help Canadians maintain and improve their health by ensuring better quality information is available to health authorities, healthcare providers, manufacturers and Canadians. This initiative will also lead to improved communication within the health sector, better understanding and monitoring of medical device safety and timely provision of accurate information in response to requests for information from internal and external stakeholders.

Beginning May , Health Canada began to provide manufacturers with a list of their medical devices associated with active medical device licenses. Manufacturers will be invited to determine the GMDN code for each device. In addition, Health Canada will be updating device application and amendment forms. When the forms are updated, device applicants will be asked to provide GMDN data as part of new applications and amendment applications.

Codes received from manufacturers will be reviewed prior to being added to the internal database. Health Canada may contact the manufacturer for clarification if the codes are incorrect; however, this will not delay processing of applications nor will a screening deficiency be issued. However, the agency is aware of the cost for manufacturers to gain membership and therefore will provide assistance in identifying GMDN codes for those unable to.

Antimicrobial resistance is currently recognized as a worldwide public health concern due to difficulty in treatment. In response, Health Canada is preparing to establish new regulatory tools and policies to help expedite the review process of therapeutic products indicated to target such pathogens and better address public health concerns. The Proposed List includes pathogens such as Acinetobacter baumanii, Enterobacteriaceae spp. It is expected that Health Canada will periodically revise the Proposed List to reflect current advances in research and innovation efforts.

In an effort to better meet public health needs, Health Canada will establish regulatory tools to accelerate the review process of therapeutic products that treat conditions caused by the pathogens included in the Proposed List. These therapeutic products drugs or medical devices may be novel products in development, or products that are already marketed outside of Canada. Sponsors can utilize the upcoming regulatory tools to submit market authorization applications with shorter review periods for therapeutic products targeting such pathogens.

However, Health Canada currently advises sponsors to consider implementing various existing regulatory pathways when submitting such therapeutic products as they can also shorten the review period of the submission. Such regulatory pathways include:. When filing a submission for a pathogen intended to address antimicrobial resistance, Health Canada suggests that the sponsor request a meeting to discuss the submission, and this meeting will also be prioritized.

For more information on the Pathogens of Interest List, please see the Health Canada Notice in the reference section below. The main objective of the Guidance is to provide harmonized principles of genomic sampling and management of genomic data in clinical studies. The Guidance facilitates the implementation of genomic studies by enabling a common understanding of critical parameters for the unbiased collection, storage, and optimal use of genomic samples and data. The Guidance is intended to foster interactions amongst stakeholders, including drug developers, investigators and regulators, and to encourage genomic research within clinical studies.

From September 28th to October 28th , the Therapeutic Products Directorate TPD of Health Canada held an online consultation on five proposed initiatives to promote in the approval process for prescription pharmaceuticals. Although majority of responses were from the drug and medical device industry 37 out of 52 responses , the consultation also received responses from health professionals and patient groups 15 out of 52 responses. The following article summarizes the responses to the consultation on the proposals for drug product transparency.

Majority of respondents agreed that a summary decision for second person submissions should be available. Industry respondents believed that this information would further their business interests by increasing their understanding of the relevant regulatory requirements. Non-industry respondents also deemed such information to be useful as it would better inform and educate the public on generic drug products.

Nearly all respondents indicated that a list of generic product submissions would be useful as it would help the industry plan for drug shortages and provide competitive intelligence. Non-industry respondents said that this may better inform patients and physicians about potential treatment options.

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However, majority of industry respondents also agreed that disclosure of the submission of a generic drug product just before market authorization would not provide the sponsor with enough time to adjust forecasts. A few respondents also said that such transparency would disclose the competitive landscape. Many of the industry respondents and non-industry respondents did not align in their opinion of this proposal. Nearly half of industry respondents did not find this proposal to be useful as such product information would already be disclosed in the Product Monograph whereas some industry respondents also said that such information about competitors would help plan business decisions.

Majority of industry respondents agreed that adding the sponsor name to the list would assist regulatory intelligence however a few respondents also noted that this may serve as a disadvantage to their own strategic marketing position as it may disclose pipeline information. However, majority of non-industry respondents agreed that this proposal would be useful and would help them directly contact sponsors for product availability information.

Both the majority of the industry and non-industry respondents agreed that this would be an useful initiative as it would provide the industry with regulatory intelligence information. However, many industry respondents mentioned that disclosure of the submission class would not serve any benefit for the public. On the other hand, non-industry respondents said that this information could provide knowledge of additional treatment options and could lead to better patient care.

It should also be noted that many industry respondents suggested that such transparency initiatives should apply to both generic and innovator drug products. For more information on the responses to the consultation on the proposals for Prescription Drug Transparency, please see the Health Canada report cited in the Reference section below. Effective immediately, no new dental plaque-disclosing product will be allowed in the marketplace without a DIN or an NPN.

Controlling plaque involves the prevention of its accumulation and its removal from the teeth and adjacent gingival tissues. Unless completely removed, plaque accumulates, mineralizes, and becomes tartar which cannot be removed by brushing or flossing and requires the intervention of a dental professional with specialized instruments.

Depending on its ingredients, a dental plaque-disclosing product can be regulated as a drug under the Act either as a pharmaceutical drug subject to the Food and Drug Regulations and requires a Drug Identification Number DIN , or as a natural health product subject to the Natural Health Products Regulations and requires a Natural Product Number NPN. Sponsors currently marketing dental plaque-disclosing products without a DIN or an NPN are granted a six-month period to submit the necessary information to Health Canada's Therapeutic Products Directorate or to the Natural and Non-Prescription Health Products Directorate in order to obtain market authorization for their products.

Non-compliant plaque-disclosing products found in the marketplace will be subject to appropriate compliance and enforcement action by Health Canada. The Australia Canada Singapore Switzerland ACSS Consortium was established to foster collaboration and synergy between regulatory authorities to address common scientific and regulatory challenges. The consortium consists of several working groups with various projects that aim to address current regulatory issues such as timely access to safe therapeutic products within a limited resource capacity. The New Chemical Entities NCE Working Group was formed by ACSS as part of an effort to develop regulatory programs through a greater alignment of regulatory approaches and technical requirements, more efficient use of resources, and the establishment of an effective network among liked-minded regulators.

The joint assessment will focus on the evaluation phase only. However, the joint assessment is not intended to replace the independent decision-making of each regulatory authority. The results of the initial trial provide the knowledge and experience that will strengthen understanding of regulatory procedures of each jurisdiction to enhance future collaborations. Among the potential benefits from this initiative is a decreased regulatory burden. Health Canada and TGA are inviting applicants interested in this work-sharing trial to contact their domestic regulatory authority.

If you are an industry member interested in participating in the work-sharing trial, please contact the regional contact for Canada at: HC. SC canada. Once the sample is approved and the pre-technical meeting has been completed, the sponsor must then request a Dossier Identifier via email to hc. The email is to be accompanied with a completed application form. Additional subsequent transactions and information following the filing of a Master File is also to be submitted in eCTD format.

Health Canada is soliciting feedback on these requirements as part of the 90 day consultation period commencing May 7, The purpose of the consultation is to receive feedback from the stakeholders on the proposed mandatory date of January 1, Interested parties are to submit their input via email to hc. Health Canada is continuing to work towards the target date of January 1, to transition to MDSAP Quality Management System certificates being accepted for medical device licence applications. Based on the comments received from industry, Health Canada has continued to work in collaboration with the MDSAP Consortium to identify additional opportunities for audit duration reductions.

As a result, manufacturers could benefit from additional reductions in audit duration if they meet the following criteria. In implementing the Guidance, Health Canada endorses the principles and practices described in the addendum. In response to the regulatory and scientific advances since the original guideline was published in , ICH developed the addendum to provide clarification and current regulatory perspectives on topics in pediatric drug development.

The following sections have been added to supplement the original guideline:. One approach is to use existing knowledge in pediatric drug development through data analytics, including extrapolation, modelling, and simulation. Practicalities in the design and execution of pediatric clinical trials. Digital health technologies are a rapidly growing area in the area of healthcare. These technologies encompass a wide range of products, from single software applications to wearables, and to hardware systems that can been connected to smartphones and computers. There technologies present the significant potential to improve access to healthcare for patients including those in rural or remote locations and to assist with timely diagnosis and treatments of many conditions.

With the widespread use of internet and mobile devices, this is also a sector of the industry that is expected to rapidly progress in upcoming years. So how does the federal regulator perceive and prepare for this change? Health Canada is showing its support for digital health technologies by establishing a new division in the Medical Device Bureau of the Therapeutic Products Directorate. As announced in the Regulatory Review of Drugs and Devices , the new Digital Health Review Division will enable a targeted pre-market review of proposed digital health technologies in order to rapidly adapt to emerging therapeutic products in digital health and allow the innovative devices to enter the market and assist healthcare.

In addition, Health Canada will also be establishing a Scientific Advisory Committee for Digital Health Technology to increase its expert review capacity of such proposed medical device technologies and arrive at decisions regarding market approval.

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Current key technological areas of focus for Health Canada include:. Establishing this new regulatory division will tend towards the development of a targeted review process for such innovative devices and better align with the regulatory review processes of other regulatory agencies and Health Technology Assessment organizations.

This will allow Health Canada to quickly adapt to fast paced innovations and continue to maintain and enforce its standards for medical device safety and effectiveness. The purpose of the Guidance is to harmonize definitions used to describe medical devices intended for a particular individual. The adoption of consistent, harmonized definitions for such medical devices could underpin a harmonized regulatory approach for controls on these devices and offer significant benefits to the manufacturer, user, patient, and to regulatory authorities.

Eliminating differences between jurisdictions supports global convergence and decreases the cost of gaining regulatory compliance. The potential reduction in regulatory red tape will also allow patients to gain earlier access to new technologies and treatments. This consultation will close on Thursday, May 24, The comment template can be find here. In response to the concern that some manufacturers will face audit scheduling challenges in and may not be issued MDSAP certificates by the deadline, Health Canada has made the following adjustment for manufacturers transitioning to the MDSAP though the surveillance audit process if they meet the following criteria:.

This adjustment allows manufacturers to maintain their existing certification cycles. Although manufacturers who transition during the surveillance audit will not receive their MDSAP certificate in , this option provides the manufacturer with the ability to continue selling their devices until they receive the certificate. In another recent development , Health Canada has announced that small-sized manufacturers could benefit from additional reductions in audit duration provided that they meet the following criteria:.

Updated duration calculations procedures have been provided to auditing organizations to apply adjustments as appropriate.

Requirements from regulatory agencies and post marketing surveillance - G.M.C. Rosano

Implementation of this ICH guidance, enables Health Canada to endorse the principles in the guidance document. While Health Canada wishes to eliminate discrepancies between the ICH guidance documents and the Health Canada guidance documents, in case of such discrepancies, the Health Canada-implemented ICH guidance documents would take precedence. Although the scope of this Question and Answer guidance does not apply to clinical trial applications, its principles may be considered throughout the clinical development stages. Moreover, a decision tree has also been provided in Annex 1 for visual assistance in the selection of justification of starting materials.

The new solvent Triethylamine was included in Class 3 solvents with low toxic potential. With the evolving nature of medicines and treatments, regulatory agencies across the world are encountering similar challenges during the review and evaluation of marketing applications and drug submissions. The creation of the Consortium allows these regulatory agencies to discuss ways to enhance and even align the regulatory reviews of certain drug products. The NCE work sharing pilot aims to allow for a shared assessment and evaluation of a NCE drug application that has been submitted to two of the regulatory agencies.

This would help alleviate challenges for the regulators when encountering difficult decision making during drug reviews. In addition, this pilot project could also benefit the pharmaceutical industry by helping to reduce regulatory burden and supporting concurrent drug submissions.

Due to regional differences in contents of the eCTD Module 1 of the submission, each regulatory agency will review its respective Module 1. For the pilot process, it will be preferred if Module of the submission contains common information to allow for the aforementioned division of review responsibilities for the regulators.

In case of differences in Module , the stakeholder should clearly highlight the differences in the Expression of Interest application form. The Guidance Document applies to drug submissions and applications involving biologics, radiopharmaceuticals, human pharmaceuticals and disinfectants regulated under the Food and Drugs Act.

What is phishing?

The coming into effect of the Guidance Document will be April 1, in respect of disinfectant drugs. The Guidance Document describes when to file drug submissions and applications for administrative processing and also describes the roles and responsibilities of manufacturers. Of note, contact lens disinfectants have been removed from the document. The consultation also addressed the resubmission eligibility criteria for drugs subject to CDR or pCODR along with various administrative changes.

On February , CADTH announced new operational changes resulting from the consultation and to enhance the drug review process. In an effort to prevent redundancy of work and to optimize resources during the review of biosimilar drug products, CADTH announced a streamlined approach for biosimilar reviews to help improve its access to the patients in need. This revision also responded to the increased number of biosimilar submissions for review. This streamlined approach includes a reduced review timeline, less submission requirements, as well as an abbreviated dossier template of the biosimilar subject to review.

As per the streamlined process, the target timeline of the Screening, Review, and Publishing phases of the Common Drug Review is a total of 44 business days, which is a significant reduction in time from the current process. This streamlined process has been made effective for all new biosimilar submissions since February 13, This information will be assessed by the pERC panel for its eligibility for resubmission. For more information on the revisions to the CADTH drug review process, please refer to the links below.

Beginning in April , Health Canada stopped accepting paper copies of Medical Devices regulatory activities and related transactions. The REP is a set of activities to facilitate the provision of information to Health Canada regarding the company and licence applications in advance of the regulatory review process.

By using a collection of web-based templates to capture metadata in a structured XML format, Health Canada can receive the information via the CESG, partially populate internal systems ahead of time, and automate certain procedures when a submission is received. Once fully implemented, the REP will reengineer existing administrative processes to take advantage of the tools and capabilities of an electronic processing and review environment. It will introduce a consistent approach to collecting high quality metadata across multiple regulatory activity types. The CESG allows sponsors to send regulatory transactions electronically to Health Canada in a secure manner, with reduced transmission times and cost.

Subsequently, the scope of regulatory activities accepted via the CESG will continue to expand to include non-eCTD electronic-only submissions for various product lines. The Guidance was prepared by the ICH and reviewed by the regulatory bodies during consultations.

By adopting the Guidance, Health Canada has endorsed the principles within. The Guidance provides a framework for the identification, categorization, and control of mutagenic impurities DNA reactive in order to limit the potential of carcinogenic risks. It applies to drug substances and drug products throughout the product lifecycle.

The Guidance can also apply to post-approval changes to an approved drug product where the manufacturing process or synthesis of the drug substance is changed and poses the possibility of mutagenic impurities. The Guidance may also apply to drug products facing formulation leading to the possibility of new degradation products. However, the Guidance would not apply to biological drugs, peptides, radiopharmaceuticals, and herbal products among others.

It also does not apply to drug products indicated for advanced cancers and drug products that have already been approved for market authorization. The Guidance focuses on DNA reactive substances which are usually identified in bacterial reverse mutation assays of mutagenicity. Other assessments include structure assessments to predict the possibility of bacterial mutagenicity. Impurity assessment usually consists of two steps where the actual impurities with mutagenic potential are first identified and if they are also present in the final drug substance.

The impurities are also evaluated per the Hazard Assessment based on literature searches. The potential impurity is then classified from Class 1 to 5 where Class 1 consists of known mutagenic carcinogens and Class 5 is to be treated as a non-mutagenic impurity. Table 1 of the Guidance lists the classification of impurities and the proposed controls. In addition to adopting the Guidance, Health Canada is informing the industry that regulatory requirements per the assessment of such potentially mutagenic impurities e.

The documents are also to be provided in PDF format. File number: The HSPTA is intended to strengthen transparency in the financial relationships that exist within Ontario's health care system for the ultimate purpose of increasing public trust and confidence. To achieve its intended purpose, the HSPTA creates various reporting requirements that apply to transactions within the context of certain relationships within the health care system. While much of the terminology is undefined in the HSPTA , the recently published Regulations provide greater clarify, for example, the Regulations :.

The Ministry is requesting feedback on this regulatory proposal. The draft Regulations are available for public consultation until April 5, Ontario's Regulatory Registry, Government of Ontario. This guidance was established to address certain technical and regulatory gaps found during consultations concerning other ICH Quality guidelines, such as Q8, Q9, Q10, and Q Unlike previously established ICH Q8 and Q11 guidelines, which focus on the early stages of the product lifecycle, the Q12 guideline provides guidance on the commercial phases of the product lifecycle.

As well, this guideline also facilitates the management of post-approval chemistry manufacturing control CMC and provides assistance on reducing regulatory burden.

Following market approval, drug products may still undergo various CMC for which communication with the respective regulatory body is required. This is due to the high potential risk to the quality of the product associated with CMC changes, and hence require a risk-based categorisation of the type communication required with the regulatory body. Such changes of high potential risk to the quality of the product, may require approval from the regulatory body before implementation. It is possible that an inspection may also be related to such changes.

On the other hand, low-risk changes may sometimes only warrant notification and would not require prior approval by the regulatory body for implementation. Such changes are to be communicated to the regulatory body as a notification or the classified submission category within the prescribed time frame.

According to the ICH Q12 guideline, harmonization of the risk-based categorization of post-approval CMC changes between regulations is encouraged. With the Common Technical Document CTD outlining all of the submission requirements for a market authorization application, there is still the lack of a harmonized approach to identify which elements of an regulatory submission are necessary for product quality and would require a regulatory submission if changed after obtaining market approval.

https://noroi-jusatsu.info/wp-content/2020-11-04/3444-espionner-a-distance.php As a result, the guidance introduces these elements as established conditions for manufacturing and control. Importantly, established conditions should not be confused for regulatory commitments such as post-approval stability commitments. Some established conditions may even be part of the manufacturing process include parameters such as critical process parameters and key process parameters. The guideline has also provided a decision tree for the identification of established conditions and their reporting categories.

It is often found that communications between regulatory evaluators and inspectors facilitate the regulatory review of a submission. All 13 Provinces and Territories have been working together to achieve greater value for brand name and generic drugs for publicly funded drug programs. A recently announced five-year initiative will provide significant savings for all Canadians using prescription generic drugs and who participate in public and employee drug plans.

This includes drugs used to treat many common disorders, including high blood pressure, high cholesterol, and depression. The generic drugs covered in this initiative are manufactured by multiple generic companies, helping to ensure a stable supply for Canadian patients. Pricing stability and predictability will also help to ensure that generic pharmaceutical manufacturers can continue to invest in bringing new cost-saving generic drugs to the Canadian market in the coming years.

These revised validation rules can be found at the reference link below to provide further information to stakeholders to assist them in the preparation of regulatory transactions in eCTD format. Since June , Health Canada has been providing the Validation Reports only for regulatory transactions that failed validation. Sponsors are expected to validate their eCTD regulatory transactions and correct any warning s or error s before sending submission to Health Canada.

Disclaimer

In late , Health Canada released a draft guidance document to assist sponsors, manufacturers, and importers on the authorization process for investigational testing of medical devices. Although Class I medical devices do not require an ITA, the draft guidance document provides some information on the responsibilities of manufacturers and importers of Class I devices subject to investigational testing.

As well, the draft guidance provides information on requesting a Pre-ITA Application meeting with Health Canada and the information required for the meeting, including a synopsis of the study and information package. In addition, per the Medical Devices Regulations , an application for an ITA is to be submitted only by the manufacturer or importer of the device to be tested, however regulatory correspondence can be assigned to a regulatory agent. For clinical trials with the use of an unlicensed medical device in Canada, an ITA application must also be filed for the device, along with the Clinical Trial Application CTA for the clinical trial.

The detailed regulatory requirements can be found in the draft guidance in the link below. The Guidance Document provides manufacturers of Class IV HIV RDTs for point of care or self-testing applications with specific guidance on the analytical and clinical data as well as labelling considerations as part of the device application process. In particular, the Guidance Document provide guidance on the labelling requirements set out in sections 21 to 23 of the Medical Devices Regulations and the analytical, clinical and near patient study design and data requirements set out in sections 32 4 i i and 32 4 k of the Regulations.

However, other safety and effectiveness considerations, such as process validation, software validation, and literature studies, are not addressed. As well, the Guidance Documents does not apply to HIV test kits used for patient management, donor screening or those intended for laboratory use.

The objective is to reduce regulatory burdens and align the regulatory requirements across various agencies. In the Notice, Health Canada encourages manufacturers to ensure that corresponding Auditing Organizations schedule a transition as soon as practicable. Manufacturers who fail to transition before January 1st, could face compliance actions and even the cancellation of their medical device licenses.

The Notice also mentions that comments were received from license holders which led to the MDSAP Consortium to make the following changes:. Last month the ACSS Consortium announced the launch of the Generic Medicines Work Sharing Trial, an innovative work sharing model for the coordinated assessment of applications for generic medicines. The trial will undertake a coordinated assessment of a generic product application to assist the regulatory decision-making within each jurisdiction. To participate in the Trial , applications should be submitted simultaneously to at least two of the ACSS Consortium members.

The lead agency, also known as the Reference Regulatory Agency, will prepare assessment reports following a review of the application. The application will also receive supplementary review by other consortium members. The Consortium voluntarily meets on a regular basis to exchange information on issues and challenges. While informal, the collaboration aims to achieve regulatory consistency between the different regimes with the goal of reducing the regulatory burden. The amendment includes guidance on ethical considerations, age classifications and subgroups for children, pediatric formulations and guidance on extrapolation in pediatric drug development and trial design.

The guideline also covers the storage and retention of genomic samples. The Act will provide restricted access to cannabis for recreational purposes, as well as regulate its production, importation, exportation, distribution, sale, and possession. The Act will provide provinces and territories will the power to regulate the distribution of cannabis. To date, several provinces have announced their proposed distribution schemes.

On November , Health Canada published a consultation paper on the proposed regulatory framework to support the implementation of the Act titled: the Proposed Approach to the Regulation of Cannabis. The consultation paper is open to the public and stakeholders to share their views and comments on or before January 20th, The Act proposes to introduce a system of licensure, permits, and authorization for various activities conducted with cannabis, such as cultivation and research. The purpose of licensure is to allow a diverse yet competitive industry for the production of quality-controlled cannabis products.

The proposed Regulations will also establish rules based on public health and safety risks. In addition to licensure, the Regulations will also require certain members of the industry, holding sensitive business information, to be subject to security clearance. The Act will also establish a Cannabis Tracking System to track the movement of cannabis through the supply chain in order to prevent diversion from the legal market.

Information will be required to be reported into the tracking system, to allow for a collection of data on inventory and production of Cannabis in Canada. However, the tracking system will not require the industry to report information on the consumers of their cannabis products. The proposed Regulations will also for the sale of dried cannabis, cannabis oil, and fresh cannabis among other product types, to people 18 years of age and above. The proposed Regulations will also establish requirements for the labelling and packaging of cannabis products for safe handling and transportation.

In addition, the packaging and labelling of cannabis products will also be required to meet tamper-evident and child-resistant requirements. Use of a healthcare claims database for post-marketing safety assessments of eribulin in Japan: a comparative assessment with a prospective post-marketing surveillance study. Drugs - Real World Outcomes. J Neurol Neurosurg Psychiatry. Pulished first online Jan 13, Research in which we were involved has been published in "Journal of Thyroid Cancer".

Secular trend in the incidence of Japanese employees with thyroid cancer undergoing thyroidectomy from to a retrospective descriptive study using an employment-based insurance claims database. J of thyroid cancer. Research in which we were involved has been published in "European Journal of Clinical Nutrition". Differences in the incidence of postoperative pneumonia after percutaneous endoscopic gastrostomy between liquid and semi-solid nutrient administration.

Eur J Clin Nutr. Published first online Jan 4, Industrial Health. Published first online Oct 19, Research in which we were involved has been published in "Journal of Infection and Chemotherapy". Greater burden of chronic comorbidities and co-medications among people living with HIV versus people without HIV in Japan: A hospital claims database study. J Infect Chemother. Published first online Nov 2, Research in which we were involved has been presented at "European Society for Medical Oncology".

Eribulin as first- or second-line chemotherapy for advanced or metastatic HER2-negative breast cancer: a real-world prospective study. Oct , Munich, Germany. Chemotherapy-induced peripheral neuropathy in breast cancer patients treated with eribulin: interim data from a post-marketing observational study. Published first online Oct 15, Aug Prague, Czech republic. Healthcare burden of recurrent Clostridioides difficile infection in Japan: A retrospective database study. Published first online Sep Drugs Real World Outcomes.

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Published first online Jun 18, Circ J. Comorbidities and the use of comedications in people living with HIV on antiretroviral therapy in Japan: a cross-sectional study using a hospital claims database. BMJ Open. Research in which we were involved has been published in "Japanese Journal of Geriatric Psychiatry". Japanese Journal of Geriatric Psychiatry.

Comorbidities and co-medications in populations with and without chronic hepatitis C virus infection in Japan between and Pregabalin as an analgesic option for patients undergoing thoracotomy: cost analysis of pregabalin versus epidural analgesia for post-thoracotomy pain relief. J Thorac Dis. BMC Musculoskelet Disord.

Decline of rotavirus-coded hospitalizations in children under 5 years: A report from Japan where rotavirus vaccines are self-financed. Published first online on Dec 11,