The globalization of pharmacetical regulation (Record no. 32714)
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| 001 - CONTROL NUMBER | |
| control field | 0043010344337 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20190211171325.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 100430s1998 xx ||||gr |0|| 0 eng d |
| 999 ## - SYSTEM CONTROL NUMBERS (KOHA) | |
| Koha Dewey Subclass [OBSOLETE] | PHL2MARC21 1.1 |
| 041 ## - LANGUAGE CODE | |
| Language code of text/sound track or separate title | eng |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | VOGEL, David |
| 9 (RLIN) | 21976 |
| 245 10 - TITLE STATEMENT | |
| Title | The globalization of pharmacetical regulation |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Malden : |
| Name of publisher, distributor, etc. | Wiley-Blackwell, |
| Date of publication, distribution, etc. | January 1998 |
| 520 3# - SUMMARY, ETC. | |
| Summary, etc. | Drugs have long been among the most extensively regulated of all consumer products. Not only do all governments closely supervise virtually every aspect of their development, testing, production and marketing, but many also regulate their pricing and distribution. The pharmaceutical industry is highly globalized, with over half the sales of the fifty largest drug companies made outside their home country (Tarabusi and Vivkery 1993). However, until recently, drug regulation was virtually synonymous with national sovereignty. Firms were required to conduct separate tests, submit separate applications, and meet distinctive criteria to enter each national market. |
| 520 3# - SUMMARY, ETC. | |
| Summary, etc. | Because drugs are so extensively regulated and have such significant health and safety impacts, drug policy coordination has proven extremely difficult. Nonetheless over the last decade, national regulatory agencies have begun to cooperate more closely with one another. The European Union has established a centralized drug approval system, the United States Food and Drug Administration has become more willing to cooperate with its foreign counterparts, and the United States, the EU and Japan have made substantial progress in harmonizing drug approval requirements under the auspices of a new international body, the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Products (ICH). This article describes and assesses the implications of the increase in international coordination of national drug approval policies. It argues that the undermining of national regulatory sovereignty has improved both the effectiveness and efficiency of government regulation. |
| 773 08 - HOST ITEM ENTRY | |
| Title | Governance: An International Journal of Policy and Administration |
| Related parts | 11, 1, p. 1-22 |
| Place, publisher, and date of publication | Malden : Wiley-Blackwell, January 1998 |
| International Standard Serial Number | ISSN 09521895 |
| Record control number | |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Koha item type | Periódico |
| 998 ## - LOCAL CONTROL INFORMATION (RLIN) | |
| -- | 20100430 |
| Operator's initials, OID (RLIN) | 1034^b |
| Cataloger's initials, CIN (RLIN) | Daiane |
| 998 ## - LOCAL CONTROL INFORMATION (RLIN) | |
| -- | 20100506 |
| Operator's initials, OID (RLIN) | 0842^b |
| Cataloger's initials, CIN (RLIN) | Carolina |
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