background preloader

Pharmaceutical Medicine - Regulatory Affairs

Facebook Twitter

The value of multi-country joint regulatory reviews: The experience of a WHO joint technical consultation on the CYD-TDV (Dengvaxia®) dossier. 130722 05. Better regulation medicine. NPRA - ASEAN Joint Assessments Procedure for Pharmaceutical Products Information. Asian Development Bank (ADB) Project. Registration And Regulatory Affairs Directorate.

Untitled. The Commission is responsible for the development and stewardship of the National Tall Man Lettering List (the List).


The Commission developed the List to help clinicians reduce the risk of medicine selection errors for medicines with look-alike, sound-alike (LASA) medicine names. The List compiles LASA medicine name pairs (generic and brand name pairs) that have been predicted to pose the greatest risks to patient safety. Regulatory Science. Use your scientific thinking to investigate and adjudicate on controversies in science.

Regulatory Science

Regulatory scientists are required to make risk-informed and evidence-based decisions, whenever new drugs, medical devices, pesticides, genetically modified organisms, foods, veterinary medicines and fine chemicals have been developed for the market. These decisions are often made in the context of uncertainty and sometimes conflict over the public availability of these goods and the risks that they might pose, in a complex environment. Regulatory scientists critically review current scientific knowledge, and assess the potential health, safety and environmental risks to human and natural systems of pre-market and post-market products and activities.

The best available scientific evidence on which they rely to make their decisions can be subject to many controversies, as can be the processes that are used. Contacts. NewDrugTherapyApprovals 2017 180104 1158am 508. BioTrack Product Database - Home page. Biosafety - BioTrack. Volume 7 covers the biology of plant species (sorghum and tomato) and relates to Atlantic salmon in 2017-16.

Biosafety - BioTrack

This is the first OECD biosafety report to address an animal species. Read more Volume 6 describes the biology, centres of origin, genetics, hybridisation, production and use, and ecology elements of several crops (sugarcane, cassava, sorghum, common bean, cucurbits) and trees (eucalyptus species) over the period 2013-15. Read more This newsletter provides an update on OECD activities related to biotechnology. Innovative drug availability in China. Labelling changes: information for sponsors. Amendments to TGO 91 and TGO 92 The TGA has made several minor amendments to the new labelling Orders Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92).

Labelling changes: information for sponsors

Many of the recent amendments were made as a direct result of feedback from industry stakeholders. The recent updates were necessary to: The compilations which incorporate the recent amendments to the labelling Orders have now been registered on the Federal Register of Legislation (FRL): New labelling requirements. Awards winners signature banners. Database Access - UNSW Library. Database Access - UNSW Library. Flexibility in the FDA approach to orphan drug development. Landmark gene therapy poised for US approval.

OGTR guidance on gene drives. 2016-17 Technical Review of the Gene Technology Regulations 2001. The Gene Technology Regulator (the Regulator) has initiated a technical review of the Gene Technology Regulations 2001 (the Technical Review) to provide clarity about whether organisms developed using a range of new technologies are subject to regulation as genetically modified organisms (GMOs) and ensure that new technologies are regulated in a manner commensurate with the risks they pose.

2016-17 Technical Review of the Gene Technology Regulations 2001

Next Steps The Technical Review is progressing towards consultation on draft amendment regulations. Review of the National Gene Technology Scheme – Consultation approach 2017. Background The intergovernmental Gene Technology Agreement requires that reviews of the National Gene Technology Scheme (the Scheme) are undertaken regularly.

Review of the National Gene Technology Scheme – Consultation approach 2017

The first review was held in 2006, with a second ‘lighter touch’ review held in 2011. The ministerial committee with responsibility for oversight of the Scheme, the Legislative and Governance Forum on Gene Technology (LGFGT), announced the current review in July 2017. Uniform recall procedure for therapeutic goods (URPTG) Go to Step 1 of the recall procedure.

Uniform recall procedure for therapeutic goods (URPTG)

Immediate recalls apply to: Immediate and significant threats Actual (or potential) product tampering Human blood or blood component Biologicals Radiopharmaceuticals For all other recalls and non-recall actions, go to Step 2 of the recall procedure. Regulatory Affairs Journals. OCS Gene Editing and CRISPR. In US FDA land – small businesses are not that small – and get fee breaks – Brandwood Biomedical. Training Videos – Brandwood Biomedical. Dealing with you Post Market Responsibilities – Brandwood Biomedical.

CFDA Device Classification – major overhaul in the works cont. – Brandwood Biomedical. 总局关于实施《医疗器械分类目录》有关事项的通告(2017年第143号) 为贯彻落实《医疗器械监督管理条例》和《国务院关于改革药品医疗器械审评审批制度的意见》(国发〔2015〕44号),国家食品药品监督管理总局于2017年8月31日发布《医疗器械分类目录》(以下简称新《分类目录》),自2018年8月1日起施行。


为做好新《分类目录》实施工作,现将有关事项通告如下: 一、新《分类目录》的总体说明 (一)新《分类目录》按技术专业和临床使用特点分为22个子目录,子目录由一级产品类别、二级产品类别、产品描述、预期用途、品名举例和管理类别组成。 判定产品的管理类别时,应当根据产品的实际情况,结合新《分类目录》中产品描述、预期用途和品名举例进行综合判定,产品描述和预期用途是用于判定产品的管理类别,不代表相关产品注册内容的完整表述。 注册申请人可以使用新《分类目录》的品名举例,或根据《医疗器械通用名称命名规则》(国家食品药品监督管理总局令第19号)拟定产品名称。 二、医疗器械注册和备案管理有关政策 (六)2018年8月1日前已受理并准予注册的首次注册申请项目,食品药品监督管理部门按照原《分类目录》核发医疗器械注册证。 三、医疗器械生产经营许可有关政策 (十一)自2018年8月1日起,持按照新《分类目录》核发的医疗器械注册证申请医疗器械生产许可的,食品药品监管部门应当依据医疗器械注册证按照新《分类目录》填写《医疗器械生产许可证》的生产范围和医疗器械生产产品登记表,其中生产范围应填写到一级产品类别。

特此通告。 食品药品监管总局2017年8月31日. The Challenges in Manufacturing Biologics. Biologic Manufacturing. Approval brings first gene therapy to the United States. This release was updated on Aug. 30, 2017 to correctly identify the FDA designations granted to Kymriah.

approval brings first gene therapy to the United States

Español The U.S. Global Novartis News Archive. 20170712 ODAC 01 FDA Backgrounder. Gene Technology Issues for Australia. Upcoming Meetings — SAC Tracker. Database Access - UNSW Library. FinalOnlinePDF 2012Reprint. Citing and referencing - Law - Library Guides at Monash University. BiomarkerCaseStudy508. New MedSearch app is now available for download. Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review. Page Last Updated: 09/14/2015 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review

Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English. Drug Approvals and Databases > Drugs@FDA Glossary of Terms. Abbreviated New Drug Application (ANDA) An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

Abbreviated New Drug Application (ANDA) Number This six-digit number is assigned by FDA staff to each application for approval to market a generic drug in the United States. Database of TGA laboratory testing results. Safety alerts When we identify serious safety or quality issues with therapeutic goods, information and recommendations are posted immediately on the Safety information pages of the TGA website. This database does NOT provide timely alerts to healthcare professionals and consumers where a serious safety or quality issue has been identified.

Database Access - UNSW Library. Press Announcements > FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis. The U.S. Food and Drug Administration today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. The approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations, to 33. The agency based its decision, in part, on the results of laboratory testing, which it used in conjunction with evidence from earlier human clinical trials. 203188s019lbl. The Journal of Law, Medicine & Ethics - Volume 41, Issue 3 - SYMPOSIUM: Institutional Corruption and the Pharmaceutical Industry. EU Member States - National competent authorities (human) The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) and the European Economic Area (EEA) responsible for human medicines.

The national competent authorities are primarily responsible for the authorisation of medicines available in the EU that do not pass though the centralised procedure. They also supply thousands of European experts who serve as members of the Agency's scientific committees, working parties or in assessment teams supporting their members. For more information on how EMA works together with the national competent authorities, see European medicines regulatory network. Medicinal products for human use. Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. Ball gallagher generics 0415. 国家食品药品监督管理总局药品审评中心. Heads of Medicines Agencies: Home. US Case Law, Court Opinions & Decisions. PDUFA VI: Highlights on What to Expect. Posted 15 August 2016 By Zachary Brennan. Prescription Drug User Fee Act (PDUFA) > PDUFA VI: Fiscal Years 2018 - 2022.

Page Last Updated: 12/22/2016 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Harvard panel examines the 21st Century Cures Act. Forms and templates. Related Information. Data sheet template explanatory guide rev 1. Database Access - UNSW Library. Untitled. The PDF file you selected should load here if your Web browser has a PDF reader plug-in installed (for example, a recent version of Adobe Acrobat Reader).

If you would like more information about how to print, save, and work with PDFs, Highwire Press provides a helpful Frequently Asked Questions about PDFs. Alternatively, you can download the PDF file directly to your computer, from where it can be opened using a PDF reader. To download the PDF, click the Download link above. Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation - - 2016 - CPT: Pharmacometrics & Systems Pharmacology.

3.1. Advancing regulatory science, advancing regulatory practice - Kurz - 2017 - Pharmacoepidemiology and Drug Safety. An Error Occurred Setting Your User Cookie. GLOBAL JOURNAL OF PHARMACEUTICAL EDUCATION AND RESEARCH. WC500224897. WC500224896. Partners & Networks - Academia. - Academia. About Us. The American Association of Tissue Banks (AATB) Home. JACIE Accreditation. Foundation for the Accreditation of Cellular Therapy. FDA Globalization. Security Sensitive Biological Agents.

SSBA Guidelines. An obscure FDA rule adding to drug company profits. Copenhagen Centre for Regulatory Science – University of Copenhagen. Laws & Regulations Database and The Republic of China. MMS: Error. 21st Century Cures Act: Making Progress on Shared Goals for Patients. CPRT 114 HPRT RU00 SAHR34. Tufts Center for the Study of Drug Development. Database Access - UNSW Library. Database Access - UNSW Library. Education and Training of a Regulatory Science Workforce - Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development - NCBI Bookshelf.

FDA Case Study 1. Office of Science Policy. Prescription medicines: registration of new chemical entities in Australia, 2016. LexisNexis Australia - Understanding Law - 8th Edition. A Tool for Predicting Regulatory Approval After Phase II Testing of New Oncology Compounds - DiMasi - 2015 - Clinical Pharmacology & Therapeutics. SAGE Journals: Your gateway to world-class journal research.

Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016. China Food and Drug Regulatory Information Network. The Diversity of Biosimilar Design and Development: Implications for Policies and Stakeholders.