Registration global

Since 1994, the automotive industry in the USA and Europe has been operating quality system certification schemes that extended the requirements of ISO 9001, ISO 10011, and EN 45012. One of these schemes was addressed by my QS-9000 Quality S /stems Handbook, published in 1996. In the same year the automakers of the USA and Europe formed the International Automotive Task Force (lATF) which, in cooperation with the technical committee of the International Organization of Standardization (TO 176), produced ISO/TS 16949. Use of and registration to this new standard is currently voluntary. It is intended that following the first revision to incorporate ISO 9000 2000, the ISO/TS 16949 certification scheme will be mandated by all major vehicle manufacturers on their Tier 1 suppliers. As a result, the standard will be cascaded along the supply chain, ultimately reaching all suppliers to the global automotive industry. 

Centre for Medicines Research. Describing Dossiers Characterising Clinical Dossiers for Global Registration. R D Briefing 25, CMR International, Surrey, UK, 2000. 

The purpose of an import tolerance and its impact on the global registration process should be explained. The official protocol document should be reviewed in general, and practical discussion should center on the worksheet and the hands-on tasks that the personnel at the meeting will be performing. 

Coordination is needed on a global scale to fulfill registrants role and commitment to make EDS a reality in NAFTA and OECD countries. To accomplish all this, well-defined plans need to be developed through an industry-government partnership and followed up with specific actions. 

The aim of the ICH is to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration and reduce or eliminate duplicate testing. This should result in better use of resources and eliminate unnecessary delay in the global development and availability of new medicines while maintaining safety guards on quality, safety and efficacy. 

New Drug Approval Process Fourth Edition, Accelerating Global Registrations, edited by Richard A. Guarino... 

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. 

The text provides explicit documentation packages to the end users globally, to develop documentation without spending a lot of money and resources. The information provided will serve as the hrst milestone to lead companies to ISO 9000 registration/certification. 

CMC preparation and global registration Marketing, sales, and distribution... 

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