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European Medicines Agency

European Medicines Agency

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10 The Food and Drug Administration (FDA) recently advanced two draft guidances1,2 proposing a regulatory framework for laboratory-developed tests, a category that includes many but not all genomic tests. The FDA convened a workshop in February 2015 to discuss the oversight of next-generation sequencing.3,4 President Barack Obama’s Precision Medicine Initiative calls for the FDA to modernize its approach to genomic testing5,6 as Senate and House committees also weigh options for genomic and other diagnostic tests.7,8 The recent initiatives by the FDA kindled debate about the legal authority of the agency to regulate genomic testing, as well as about the potential effects that such regulation may have on discovery and innovation.9-13 Skeptics raise important concerns, but there is little doubt that the FDA has ample power to impose at least some new regulatory requirements on genomic testing — enough, in any event, to make laboratory directors squirm. The Challenge of Clinical Validity

Consultation: Regulation of autologous stem cell therapies: Discussion paper for consultation 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 Aseptic Transfer Risk Assessment: A Case Study Peer Reviewed: Case Study This paper uses one example of a risk assessment approach to illustrate how risk assessment can be incorporated into good manufacturing controls. The specific activity assessed involves transferring a set of sterilised stoppers from an autoclave to a filling machine within a sterile manufacturing facility. The risk assessment approach adopted is a form of HACCP (Hazard Analysis Critical Control Points). Approaches to risk assessments are discussed. Key activities are described.

Dentons - Changes to the regulation of pharmaceutical business in Kazakhstan: implications for pharmaceutical companies May 4, 2015 A significant number of amendments have been introduced to the Healthcare Code* of the Republic of Kazakhstan on 6 April 2015 by the adoption of the Law On Introduction of Amendments and Additions to Certain Legal Acts of the Republic of Kazakhstan on Healthcare Matters (Law on Amendments). Most of the amendments came into effect on 19 April 2015. Also, the Rules on Advertisement of Medicines, Medical Items and Medical Equipment were adopted by the Order of the Minister of Healthcare of the Republic of Kazakhstan dated 27 February 2015 No 105 (Advertisement Rules).

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. The TGA will not require applicants preparing eCTD submissions to use the same software as the TGA and any software compliant with eCTD 3.2.2 should be acceptable. However, it is expected that applicants will validate all submissions prior to sending them to the TGA. 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. - A to Z Directory of companies in Labhoo There are 21928 companies in total in our directory. 146A2168B1839c1900D835e865F512G870H674I1085J250K398L843M1558N875O502P1498Q151R701S1925T1049U345V400W385X75Y63Z116 VVA Health Marketing publish a variety of medical, dental and laboratory related titles including "Arab Medico", "Arab Dental" "First Class Health" "Buyers Guides" for Arabia and Russia, and is constantly updating and introducing new titles to meet today' V&P Scientific makes Pin Tools for most robotic systems to transfer nanoliter through microliter volumes from microplates to membranes, other microplates, agar or glass slides. V&P Scientific also makes unique magnetic stirrers that stir and heat viscous Since its founding in 1979 by Dr.

Registration in Kazakhstan Registration, reregistration and variations to the registration dossier of medicinal products in the Republic of Kazakhstan is determined by Order of MOH № 735 from 18th November, 2009 “On approval of rules on state registration, reregistration and variations to the registration dossier of medicine, medical purpose products and medical equipment.”, amended on 15th February, 2012 № 84 MOH. In accordance with the current law for state registration and reregistration are subjected medicines, that are produced in the Republic of Kazakhstan, as well as imported into its territory medicines registered in the country of origin, including: • Medicines indicating the dosage form, dosage, packaging;

Update 2: EU DCP: International collaboration for the evaluation of generic drugs 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 essential list of guidances for software medical devices - Software in Medical Devices This page gathers the guidances and other documents about CE mark and FDA 510k for software medical devices. I limited the list to documents, which have an impact on design. Go to the list of FDA guidances CE Mark Guidances I picked the documents in websites of the following organisms: If you’re looking for documents about other steps of the software lifecycle (clinical evaluation & investigation, post-market surveillance and vigilance), you’ll find what you’re looking for in those websites. Antibiotic Resistance Snapshot data-visualization on antibiotic resistance. » Data and more information here: » Download a poster from our PDF store Part of the infographic mega-tome, Knowledge is Beautiful. Find out more. » Purchase: Amazon US or Barnes & Noble | UK or Waterstones » Download: Apple iBook | Kindle (UK & US) » See inside For more graphics, visualisations and data-journalism:

Submissions received: Regulation of autologous stem cell therapies The TGA sought comments from interested parties on Regulation of autologous stem cell therapies, regarding whether the regulation applied to some autologous cells is appropriate, in a consultation that closed on 3 March 2015. A total of 80 submissions were received. Of the submissions 14 from professional bodies, 12 from researchers, institutions or hospitals, 4 from industry groups, 4 from consumer groups, 20 from manufacturers, suppliers or health practitioners providing autologous stem cell therapies (businesses), 21 from patients and 5 from government bodies or other stakeholders. All submissions that were not marked as confidential are now available below in PDF format. Consultation feedback The TGA is currently considering all submissions that were received as part of this consultation.

Awakening the Third Eye – Be Careful What You Wish For Gregg Prescott, In5D GuestWaking Times Have you ever heard the expression, ‘Be careful what you wish for’? For some people, the opening of the 3rd eye can show them things that they really didn’t want to see. For others, it’s a journey of enlightenment.

Agile development in a FDA regulated setting I ran across an interesting Agile v. FDA discussion the other day. For those that are not familiar with what a FDA regulated product means, I’ll give a brief overview.

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