Harmonization initiatives

The Codex Alimentarius Committee on Residues of Veterinary Drugs in Foods in 1985. 

The US FDA and the European Union have held regular bilateral meetings for the last decade to discuss common areas of interest. This has involved mutual exchange of guidelines for consultation. 

Meetings on harmonization of veterinary biologicals were held in 1992 in Ploufragan, France in 1994 in Arlington, Virginia, US and in 1995 in Singapore. 

In 1993, the Global Harmonization of Standards (GHOST) discussion document was published by FEDESA. This sets out a program for the international harmonization of registration requirements for veterinary pharmaceuticals and biologicals. 

Following discussions at ITCVDR and Office International des Epizooties (OIE) conferences, the OIE set up an ad hoc group on the harmonization of veterinary medicinal products in 1994. 

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The International Conference on Harmonisation differs from many other harmonization initiatives in that it has a recognized status and is backed by a commitment on the part of both industry and regulators, to facilitate greater harmonization of technical requirements in the three regions. Commitment to these objectives, set out in the Terms of Reference, was re-affirmed by the Steering Committee in a statement issued following the meeting held in Tokyo, October 1990. 

ICH can look back to 15 years of achievements. As the most successful international harmonization initiative in the world, its achievements include an understanding of innovation a common regulatory platform based on more than 40 guidelines improvement of scientific guidelines facilitating communication between the regulators, and between industry and the regulatory authorities effective use of research and development... 

Harmonization initiatives can occur as a result of specific agreements between two or more countries, as in Europe (EU) through the European Conunission (EC), in North America under the North American Free Trade Agreement (NAFTA) or more broadly under the umbrella of international nongovernmental organizations such as the Organization for Economic Co-operation and Development (OECD). 

The Secretariat reminded the Committee that the WHO guidelines had been revised in the light of harmonization efforts in collaboration with ICH. Subsequently focus had been placed within regional harmonization initiatives on the recommendations for hot and humid conditions (referred to as Zone IV). After extensive discussion the Committee reached consensus that the WHO stability guidelines be amended to reflect conditions for Zone IV as follows ... 

International Conference on Harmonisation (ICH) The ICH was formed to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. The ICH is sponsored by the European Commission, the European Federation of Pharmaceutical Industry Associations, the Japanese Ministry of Health and Welfare, the Japanese Pharmaceutical Manufacturers Association, the U.S. Food and Drug Administration, and the Pharmaceutical Research and Manufacturers of America. The objective of the ICH is to harmonize the technical requirements for the registration of pharmaceutical products in the European Union, Japan, and the United States. 

To choose the phase windows for 0 and 0/, we have to assign to < )fl and b particular values. It is interesting to notice that formula (143) depends, in fact, on the difference 2< >a — which reproduces the classical phase relation for the second harmonic generation, as seen in in classical equations (59). Classically, if there is no second-harmonic initially, this quantity must be 2<[)a (])fc = ji/2. This means that the phase of the second-harmonic mode... 

These realities are some of the catalysts for regional medicines harmonization initiatives such as the African Medicines Regulatory... 

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