By S. Ratanawijitrasin
Medications play a vital function in saving lives, restoring wellbeing and fitness, and fighting 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 will be topic to executive keep an eye on via prescribed norms and criteria and a good regulatory approach. Substandard and counterfeit medicinal drugs proliferate essentially in an atmosphere the place drug legislation has proved ineffective.This ebook provides a synthesis of reviews on drug legislation conducted in 10 nations: Australia, Cuba, Cyprus, Estonia, Malaysia, the Netherlands, Tunisia, Uganda, Venezuela, and Zimbabwe in 1998-1999. It provides an outline of the improvement of drug rules in those nations in addition to the assets to be had and the suggestions utilized in drug rules implementation on the time the reports have been carried out. An research of the strengths and weaknesses in drug legislation in those international locations is usually supplied.
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Additional info for Effective Drug Regulation: A Multicultural Study
For the rest of the group, with the exception of Cuba, which does not have a private sector, government employees receive lower pay than private-sector employees. The lower level of remuneration generally leads to two problems in personnel management: difficulty in recruiting qualified people and difficulty in retaining them. In extreme cases it may also lead to corruption. Staff shortages appear to be a serious problem in all 10 countries. Difficulty in recruiting staff was cited in six countries, while there was difficulty in retaining staff in four countries.
Implementing a public policy through multiple levels of government with autonomous authority requires a concerted effort between the agencies at both levels in order to attain the same regulatory objectives throughout the entire country. In Malaysia, coordination between the federal and state regulatory authorities has been created by 42 establishing a Deputy Director of Health in each state, who reports directly to the Pharmaceutical Services at federal level. In Australia, the TGA has two committees: the National Coordinating Committee on Therapeutic Goods and the National Drugs and Poisons Schedule Committee, whose role is to ensure adequate and appropriate communication between federal and state levels.
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. The current drug regulatory structures were established only recently. The National Regulatory Authority and NCDQC were created by ministerial decree in 1989. Rules for drug registration were instituted in 1995, also by ministerial decree. Venezuela developed its drug regulation system relatively early.