International Pharmaceutical Registration

Description

International Pharmaceutical Registration has been prepared in response to numerous requests to provide a practical overview and guide to the complexities of pharmaceutical registration internationally. With the increasing globalisation of pharmaceutical markets and continuing consolidation within the pharmaceutical industry, the challenges of rapidly evolving regulatory requirements, including the opportunities presented by increased harmonisation of regulatory guidelines in ternationally have forged a much greater appreciation of the need for regulatory awareness.

Individual country chapters are written by national experts from regulatory authorities, international pharmaceutical companies and regulatory consultants. This was an intentional approach to emphasise the partnership involved in regulatory affairs between the regulators and the industry in the spirit of cooperation as reflected in such endeavours as the International Conference on Harmonisation (ICH). Whereas the ICH has focused on the major centres of pharmaceutical research and development, namely the European Union (EU), Japan and the United States, which led to many harmonised guidelines covering these areas (and recognised also in many other countries), the wider international pharmaceutical regulatory world remains much more diverse.

Contents
�Australia
�Belgium and Luxembourg
�Brazil
�Bulgaria
�Canada
�European Union
�France
�Germany
�Gulf States
�Hungary
�India
�Ireland
�Israel
�Japan
�Korea
�Malaysia
�Netherlands
�New Zealand
�Nigeria
�Poland
�Portugal
�Russia
�Singapore
�Slovak Republic
�South Africa
�Switzerland
�Thailand
�Tunisia
�Turkey
�Ukraine
�United Kingdom
�United States

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