International harmonisation process

It was generally assumed that following the ICH 4 meeting in 1997 that International Harmonisation had reached an interim conclusion and that the future would focus on developing a Common Technical Document (CTD), to improve efficiency in documenting new medicines for regulatory purposes. However, the ICH process... 

The International Conference on Harmonisation Process. Accessed from http //www. ifpma.org/ich4.html on 9 May 2000. 

A first step towards international harmonisation of standards for the organic markets has been made with the adoption of the Codex Guidelines on the production, processing, and labelling of organically produced foods. However, there still are many obstacles to be overcome, and new obstacles are being raised by governments and private bodies in order to protect the domestic industry from imports. 

Thus, it is not altogether clear how internal work processes have contributed to proportionate, transparent and harmonised enforcement practices. Certainly, there have been rumours and some complaints from consultants and other external observers about hidden orders and laek of accountability. ° The important point, however, is the general laek of close legal scrutiny and pressure from the industry to test out the... 

The standards for electrical equipment for use in flammable atmospheres are affected by the harmonisation processes of the EEC, CENELEC (European Committee for Electrotechnical Standardisation) and the lEC (International Electrotechnical Committee). 

The relevant standards have been affected by the standard harmonisation process within the EU through the European Committee for Electrotechnical Standardisation (CENELEC) and through the International Electrotechnical Commission (lEC). Individual parts of BS EN 60079 deal with different aspects concerning electric apparatus for potentially explosive gas atmospheres, namely classification of hazardous areas, electrical installations in hazardous areas (other than mines) and inspection and maintenance of electrical installations in hazardous areas (other than mines). BS 50014 covers general requirements. 

Advisory Group are considering different facets of LCA. In 1993, they developed the Code of Practice ,the first worldwide accepted technical framework for LCA. This was an important step towards the harmonisation of the method and has initiated and supported the standardisation process by ISO. Between 1997 and 2000, ISO produced the international series of standard defining the different stages of the LCA methodology (ISO 14040 1997, ISO 14041 1998, ISO 14042 2000 ° as well as ISO 14043 2000° ). As mentioned above, these standards were replaced by two improved editions of life cycle assessment standards in 2006 (ISO 14040 2006 and ISO 14044 2006°). 

The present volume of the series focuses on the interplay between organisms and the physical chemistry of the environmental media in which they live. It critically discusses the different physicochemical and biophysical features of the kinetics of processes at the biointerface, with special attention given to aspects such as bioavailability of chemical species, analysis of the necessary mass transfer towards/from the biointerface, routes of transfer through the biomembrane, etc. This volume was realised within the framework of the activities of the former IUPAC Commission on Fundamental Environmental Chemistry of the Division of Chemistry and the Environment. We thank the IUPAC officers responsible, especially the executive director, Dr John Jost, for their support and assistance. We also thank the International Council for Science (ICSU) for financial support of the work of the Commission. This enabled us to organise the discussion meeting of the full team of chapter authors (in Diibendorf, Switzerland, 2001) which formed such an essential step in the preparation and harmonisation of the various chapters of this book. 

International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals. S2A document recommended for adoption at step 4 of the ICH process on July 19, 1995, Federal Register 61 18198-18202, April 24,1996. 

It was agreed, from the start, that the focus for discussions of tripartite harmonisation should be an international conference or series of conferences. The Steering Committee recognised the importance of ensuring that the process of harmonisation is carried out in an open and transparent manner and that ICH discussions and recommendations are presented in open forums. 

Hypoalgesia ICH (International Conference on Harmonization) Diminished sensitivity to a noxious stimulation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to harmonise scientific and technical aspects of product registration. They make recommendations which will be adopted by the national / EU authorities after an approval process. 

The International Conference on Harmonisation (ICH) Q1A process established principles and conditions that are acceptable in the United States, the European Community, Japan, and many other countries. Nonetheless, it is the sponsor, who, having the most knowledge, information, and data on the product, must ultimately define the most appropriate program to evaluate the stability of its products using the defined regulatory principles. 

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