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Browse English Issue Headlines - November 2005

Combination Products

Combination products are becoming an increasingly important area of development both in the pharmaceutical and in the medical device industries. Just over a decade ago, the title ‘combination product' would have been understood to refer to a fixed combination of two or more pharmaceutical active substances in the same presentation. How times change. In 2005, any reference to a combination product, whether at a scientific or a regulatory affairs meeting, will automatically be assumed to refer to a combination of a pharmaceutical agent and a medical device. In this editorial, Dr David Jefferys discusses the breakdown of classic combination distinctions, reviews the current regulatory controls in this area, and considers the future challenges for combination products. More >>

Origin & Work of the European Notified Body Operations Group

Due to concerns about the uneven and inconsistent performance of European Notified Bodies in the late 1990s, the Notified Body Oversight Group was established in 2000. The Chair of this Group, Steve Owen, now explains the purpose of this Oversight Group and the terms of reference it works to. Mr Owen also reports on some of the most significant achievements of the Group so far, including publication of the Designating Authority Handbook in December 2003, as well as discussing the future direction and work of the Group. More >>

US FDA Regulation of Combination Products

The recent technological strides in disease prevention and treatment are staggering in their scope and complexity. Based on what appears to be this continuing trend, one can only envision that understanding the regulatory requirements for yet-to-be-developed novel solutions to medical problems will be even more challenging to regulatory affairs professionals in years to come. As the distinctions between different forms of medical products blur, the importance of having a structured and transparent regulatory process cannot be underestimated. Many of the challenges facing the regulatory affairs professional dealing with today's combination products stem from the fact that combination products are currently regulated within the existing statutory framework for their components (drug, device or biologic) that may be outside their usual expertise and not under a separate statutory system. Rosina Robinson provides an introduction to the US Food and Drug Administration (FDA) regulation of combination products and planned future developments. The regulation of combination products by non-US regulatory bodies is not considered in her review. More >>

Japan Medical Device Update

The medical device market in Japan still remains the largest device market in Asia and is the second largest medical device market in the world, valued at approximately US$24 billion. Japan's Ministry of Health, Labour and Welfare is feeling a growing pressure to improve the regulatory and safety environment for medical devices, as well as the transparency and efficiency of the country's healthcare and related regulatory systems. In this article, Ames Gross and Rachel Weintraub report on the implementation of the new Pharmaceutical Affairs Law and its effect on foreign companies now entering the medical device regulatory environment in Japan, as well as those already present in the country. More >>

European Update

  • Estonia's State Agency for Medicines moves to new location
  • Reclassification of hip, knee and shoulder joint replacements
  • 16th meeting of the EU Competent Authorities
  • Physical Agents (electromagnetic fields) Directive
  • EUCOMED's reaction to medical devices competitiveness study
  • European quality mark may now be used independently
  • Two new French Decrees issued
  • Germany's DAMA delayed
  • Guidance in preparation on auditing by the Irish Medicines Board
  • Manufacture of medical devices in healthcare institutions
  • Netherlands MEB strategic business plan 2005-2009
  • Portugal's recommendations for use of metallic tracheal stents
  • INFARMED provides clarification to purchasers of medical devices
  • Swissmedic published recall information on the internet
  • Small steam sterilisers: Swiss guidance issued
  • Swiss technical standards for medical devices
  • UK's Device Evaluation Service moves
  • UK's guidelines on wheelchair stability
  • Medical device alerts issued by the UK MHRA
  • Adverse events associated with breast implants

More >>

US Update

  • Medical device user fees stabilised under new law
  • Users fees for fiscal year 2006
  • FY 2006 MDUFMA small business qualification
  • Combination products: definition of primary mode of action
  • Classification of RNA pre-analytical systems
  • Classification of AFP-L3% immunological test systems
  • Classification of oral rinse dental devices
  • Reprocessed single-use devices
  • Needle-bearing devices: withdrawal of ANPRM
  • Classification of the endotoxin assay: technical amendment
  • Metallic tracheal stents in patients with benign airway disorders
  • Unique device identification
  • Final guidance document summaries
  • Draft guidance document summaries

More >>


  • Advertising and promotion in Argentina
  • TGA fees and charges for 2005/2006
  • New Conformity Assessment Standards Order
  • Concerns over end of device legislation transition period
  • Australia's new in vitro diagnostic (IVD) legislation
  • Prostheses reimbursement scheme in Australia
  • New technical centre for healthcare technology products in Brazil
  • China's review of advertising approval procedures
  • SFDA publishes 2004 inspection results for anaesthesia machines
  • Second phase of Hong Kong's MDACS soon to be launched
  • Australia/New Zealand transition scheme for medical devices
  • Brazil and Argentina agree joint work programme
  • Trans-Pacific free trade agreement
  • US/Oman free trade agreement
  • US/Dominican Republic free trade agreement
  • Lesotho and Dominican Republic join IEC affiliates
  • Iraq issues drug registration regulations
  • New Japanese labelling requirements
  • Foreign manufacturers in Japan
  • Japan releases guidance on GCP compliance reviews
  • Singapore's Health Products Bill

More >>

Environment Update

  • Hazardous substances in electrical and electronic equipment
  • Waste electrical and electronic equipment
  • Packaging and packaging waste

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Standards Update

  • Harmonised EU standards

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Reference Information

  • Regulatory personnel on the move
  • Country overview: Philippines
  • Elemental Essentials: Global Harmonisation Task Force (GHTF)
  • US CDRH Advisory Committees
  • Current Australian Therapeutic Goods Orders (TGOs)
  • Book review: A New Model for European Medical Device Regulation

More >>