Welcome to Ministry of Health, Labour and Welfare About Our Logo and Catchphrase Policy Information What's new Daily information Service RSS about RSS Archives Daily Information Service may be unable to be displayed by the version of a browser. Organization White Paper & Reports Statistics & Other Data Skip to Information concerning 2011 Tohoku - Pacific Ocean earthquake Central Labour Relations Commission Examples of Leading Activities of Private Companies in the Fields of Health, Labour, and Welfare Photo Report 14th Japan-EU Symposium Tokyo, 18 July 2012 > Photo Gallery Policy Report Integrated Efforts toward the Promotion of Life Innovation > Policy Report Please leave your message & inquiry to: email@example.comAbout this Homepage Copyright © Ministry of Health, Labour and Welfare, All Right reserved.
Government of Canada Radon Guideline Health Canada www.hc-sc.gc.ca Home > Environmental & Workplace Health > Radiation > Radon The Canadian guideline for radon is 200 becquerels per cubic meter, If the radon level is found to be high, it can be fixed. Health Canada collaborated with the Federal Provincial Territorial Radiation Protection Committee (FPTRPC) to review the health risk from exposure to radon. The Minister recommends that Remedial measures should be undertaken in a dwelling whenever the average annual radon concentration exceeds 200 Bq/m³ in the normal occupancy area. Points of clarification In addition to residential homes, the term "dwelling" in this guideline also applies to public buildings with a high occupancy rate by members of the public such as schools, hospitals, long-term care residences, and correctional facilities. Stay Connected with Health Canada's Social Media Tools!
Therapeutic Goods Administration (TGA) Bills and Legislation Search all bills Browse all bills by title Bills lists These publications provide a complete list of all bills before Parliament for the current calendar year and details of their progress through both houses of Parliament. Back to top Bills and committees The House of Representatives Selection Committee and the Senate Selection of Bills Committee routinely consider whether bills should be referred to committees for inquiry and report. Related resources and links Update 2: EU DCP: International collaboration for the evaluation of generic drugs | Therapeutic Goods Administration (TGA) The TGA is participating in an international collaboration programme led by the European Union (EU) under the auspices of the IGDRP through which, upon request from a generic pharmaceutical company, the assessment reports generated as part of EU Marketing Authorisation procedures will be shared in real time with collaborating regulatory agencies outside the EU such as the TGA. The IGDRP was launched in April 2012 with the aim of regulatory agencies to pursue collaboration and convergence to mitigate challenges of worldwide generic global development and approval programs. As part of the IGDRP, an information sharing pilot has been initiated in July 2014 using the European Union's Decentralised Procedure (DCP) as a model for the sharing of information during the scientific assessment phases of the DCP with IGDPR non-EU agencies, including the TGA. The first phase of the pilot project will involve the EU, Australia, Canada, Chinese Taipei and Switzerland. List of eligibility criteria.
Consultation: Regulation of autologous stem cell therapies: Discussion paper for consultation | Therapeutic Goods Administration (TGA) Closing date: 3 March 2015 Invitation to comment The TGA is seeking comments from interested parties on Regulation of autologous stem cell therapies - Discussion paper for consultation. Consultation documents How to access a pdf or Word document Timetable Documents released for consultation on Tuesday 6 January 2015. Interested parties should respond by close of business Tuesday 3 March 2015. Feedback will be released following consideration of submissions. About the consultation The TGA is considering whether the regulation applied to some autologous cells is appropriate. The specific autologous stem cells under consideration are those that are taken from a patient and used under the supervision of a medical practitioner who is caring for that patient for a single indication in a single course of treatment. Response to the consultation will help inform what, if any, regulatory change is needed. Background Human cells and tissues are used in many therapeutic applications. Content of submissions
The eCTD summit: Expert Commentary for Electronic Regulatory Submissions Australian eCTD submissions | Therapeutic Goods Administration (TGA) The TGA is planning to implement software to validate, review and process electronic submissions for the entry of registered medicines on to the Australian Register of Therapeutic Goods (ARTG) in 2015. Other regulated products are not currently included in the project to implement eCTD submissions. This software will be used for submissions in both electronic Common Technical Document (eCTD) and non eCTD (NeeS) formats. For your information, a pilot phase is underway to test submissions for a new chemical entity, major variations to a prescription medicine (both with and without baseline) and a generic medicine in order to identify any potential issues before the system is made operational. Timeline Review of documents The TGA is seeking comment on some of the eCTD technical documentation. Validation tool The following vendors have provided links to their validation tool which may be used in the application process: Australian eCTD files Pilot phase - Frequently asked questions
Energy and Commerce Cures A path to 21st century cures Mission In the 21st century, health care innovation is happening at lightning speed. From the mapping of the human genome to the rise of personalized medicines that are linked to advances in molecular medicine, we have seen constant breakthroughs that are changing the face of disease treatment, management, and cures. Health research is moving quickly, but the federal drug and device approval apparatus is in many ways the relic of another era. Over the next several months, members will take a comprehensive look at the full arc of this process - from the discovery to development to delivery - to determine what steps we can take to ensure we are taking full advantage of the advances this country has made in science and technology and use these resources to keep America as the innovation capital of the world. WATCH Chairman Upton and Rep. White Papers 21st Century Cures: A Call to Action (May 1, 2014) Respondents (Responses 1-6, 7-35) Discussion Document News U.S.
Welcome to ECPM MS in Biotechnology Innovation Regulatory Science - College of Technology This new area of specialization in the College of Technology focuses on creating leaders in biotechnology innovation and regulatory science, especially relating to pharmaceuticals. The curricula also addresses topics of innovation and integrates emerging technologies. The program consists of 10 courses and a special project for a total of 33 credit hours. The array of courses will provide: an understanding of all aspects of quality an understanding of biotechnology innovation and regulatory science in-depth knowledge related to biotechnology and pharma knowledge on how to lead and manage operations within the industry Choose the degree format that best fits your needs: Traditional, on-campus degree program in West Lafayette Blended online and weekend program, administered through the Center for Professional Studies (ProSTAR) In Africa in collaboration with Kilimanjaro School of Pharmacy, Moshi, Tanzania.
PATH: Global Health Technologies Coalition Health technologies have the potential to save millions of lives each year. Millions of people die annually from HIV/AIDS, malaria, and tuberculosis, and an estimated one billion are devastated by neglected tropical diseases. The world urgently needs new vaccines, drugs, microbicides, and diagnostic tests to slow these global threats and tackle many other pressing health needs. However, insufficient funds for research and development (R&D), regulatory challenges in approving new technologies, and a perceived lack of a market for such products by private industry can hinder the development of new health solutions for the developing world. To remove these obstacles, a diverse group of nongovernmental organizations have come together as partners in the Global Health Technologies Coalition (GHTC). Influence through collaboration The coalition works to: Build and support an informed and influential constituency for global health technologies. A trusted resource Diverse members, shared focus
Strategy of SAKIGAKE by MHLW | Pharmaceuticals and Medical Devices Agency Here begins the text. On June 17th, 2014, the Ministry of Health, Labour and Welfare (MHLW) announced the "Strategy of SAKIGAKE" to lead the world in the practical application of innovative medical products. The "Strategy of SAKIGAKE" covers from basic research to clinical research/trials, approval reviews, safety measures, insurance coverage, improvement of infrastructure and the environment for corporate activities, and global expansion. One of the major policies of the "Strategy of SAKIGAKE" is the "SAKIGAKE Designation System," which promoting R&D and early clinical research/trials in Japan aiming at early practical application for innovative medical products with prospective significant efficacy by conducting priority consultations, prior assessment, and priority reviews. Together with MHLW, PMDA will work towards implementation of the strategy.