Download e-book for iPad: Effective Drug Regulation: A Multicountry Study by S Ratanawijitrasin;E Wondemagegnebu


By S Ratanawijitrasin;E Wondemagegnebu

ISBN-10: 9241562064

ISBN-13: 9789241562065

Medicines play an important function in saving lives, restoring overall healthiness, and combating ailments and epidemics. yet they should be secure, efficacious, of fine caliber, and used rationally. which means their creation, import/export, garage, provide and distribution could be topic to executive regulate via prescribed norms and criteria and an efficient regulatory approach. Substandard and counterfeit medicinal drugs proliferate essentially in an atmosphere the place drug law has proved ineffective.This e-book offers a synthesis of reports on drug legislation performed in 10 international locations: Australia, Cuba, Cyprus, Estonia, Malaysia, the Netherlands, Tunisia, Uganda, Venezuela, and Zimbabwe in 1998-1999. It offers an summary of the improvement of drug rules in those international locations in addition to the assets to be had and the thoughts utilized in drug law implementation on the time the reports have been carried out. An research of the strengths and weaknesses in drug legislation in those nations is additionally supplied.

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1 Different evolutionary paths Cuba has a long history of drug regulation. The first regulation relating to drugs, the royal act Real Tribunal Protomedicato was enacted in 1709. This law did not, however, attempt to control “drugs” themselves, but rather aimed to regulate pharmacists and medical activities. In 1833, the enactment of the Superior Royal Board of Pharmacy Regulation was aimed not only at regulating pharmacy and the medical profession, but also at regulating drugs. After the 1959 revolution, private manufacturers and pharmacies were nationalized.

5 drug regulatory staff per 1 million population, respectively, Uganda and Zimbabwe have only 3-4 drug regulatory staff per 1 million population. Given the small size of both the DRA and the populations of Cyprus and Estonia (the two smallest in the group), the figures suggest that a higher proportion of human resources may be invested in drug regulation in small countries than in larger countries. 00 Staff per million population * Australia: TGA only. During 1997/98, the Australian public service was extensively restructured, and many staff were redeployed.

Estonia’s drug regulatory framework has begun to take shape only over the last decade, since the country gained independence. However, the pace of regulatory development has been rapid. The Licensing Board of Pharmaceutical Activities and the Centre of Medicines were both created in 1991. Registration and licensing were introduced that year. In 1993, the SAM was created to become the DRA. The main legislation—the Medicinal Products Act—came into force in 1996. 2 Patterns of development Some observations can be made on the basis of the country data relating to the historical development of drug regulation.

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Effective Drug Regulation: A Multicountry Study by S Ratanawijitrasin;E Wondemagegnebu

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