PRODUCT ASSESSMENT AND REGISTRATION

Regulatory functions include licensing of persons, premises and practices, inspection of pharmaceutical establishments, product assessment and registration, QC, control of dmg promotion and advertising and monitoring of ADR. 

Legal requirements for pharmaceutical product assessment and registration specify how pharmaceutical production should be carried out, and lay down requirements concerning packaging, information to be provided by labels and inserts, methods of analysis, etc. 

In all 10 countries, licensing of manufacturing, product assessment and registration, GMP inspection, import controls and control of product quality are determined by legislation. Licensing of importation and wholesale trade is not required in Cuba and Cypms, however. In Zimbabwe, a licence is required for wholesale trade. 

An official product assessment and registration system for pharmaceuticals exists in each of the 10 countries. Their functions are determined by legal provisions. Systems for registration of pharmaceutical products came into operation at quite different times in the 10 countries — as early as 1942 in Tunisia and as late as 1993 in Uganda. Some of the systems have evolved in response to dmg-related crises such as the thalidomide disaster, public pressure to expand the scope of dmg assessment and the pressure from industry and consumers to expedite the registration process. 

Does workload affect the time taken for assessment and registration Since the registration of products containing new chemical entities requires the most extensive review and expertise, it is used for this analysis. The data are the same as those presented in Figure 8.5. 

Worker exposure data Is a major component of risk assessment for the use of agricultural chemicals. It has become a routine part of the product review and registration process for new chemicals. 

Two key indicators of the effectiveness of registration are whether all products on the market with a medicinal claim have been assessed and registered and whether the... 

In considering pesticide residues, it was clearly shown that crops from organic production systems contain no or significantly lower levels of pesticide residues than crops from conventional systems (Baker et al., 2002). However, while some scientists are concerned about the potential health impacts from such residues (Porter et al., 1999 Benbrook, 2002), pesticide legislators maintain that current pesticide risk assessments and pesticide registration procedures are adequate and that residues below the current legal limits can not have a negative health impact in humans (e.g. PSD, 2006). 

In what is being called the most far-reaching overhaul of European Union environmental policy ever, the European Commission released a draft policy proposal on May 7 that, if enacted, would require virtually all manufacturers of chemicals to provide risk assessments and other information regarding products they sell or ship into the EU. Chemicals would also have to be registered with the EC and many downstream users of products that contain chemical entities would have to file paperwork as well. The Registration, Evaluation and Authorisation of Chemicals, or REACH, proposal would apply to approximately 30,000 new and existing chemicals, and test data would have to be developed on some 5000 specific chemical entities, many of which have been commonly used for decades. EUROPEAN COMMISSION... 

If the drug product in the registration stability study is not the same as the product used in the clinical trials, the differences must be assessed. Likewise, any differences between the drug product in the registration stability study and the product to be marketed must be assessed. All differences should be explained and justified. Release data comparisons and/or a bioequivalence study may be required, depending on the significance of the differences. 

More than 200 professionals (physicians, pharmacists and scientists) take part in the assessment of registration files (Ministere de la Sante Publique 1997). In fact, medicinal product registration on the Tunisian meu-ket includes several processes. A diagram summarizing these processes can be found in Appendix 2. 

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