Regulatory authorities generics

This debate is particularly pertinent as some of these first generation biopharmaceuticals produced by rDNA technology are coming off-patent, as shown in Table 10.3, and the generics industry aims to tap into this market, while at the same time regulatory authorities are under pressure to work toward making drugs more affordable to patients. 

WHO. Marketing authorization of pharmaceutical products with special reference to multisource (generic) products. A manual for a drug regulatory authority. Geneva World Health Organization 1999. (WHO/DMP/RGS/98.5). 

For firms that manufacture several products from one source (e.g., Chinese hamster ovary [CHO] cells), a generic approach may suffice. Regulatory authorities in some countries are accepting this approach [13]. There are also some generic kits on the market that can be used to study host cell protein clearance during development, and may be considered acceptable for licensure. 

NCRP has developed a recommendation on a negligible individual dose that could be used to establish exemption levels for radioactive waste for such purposes as disposal and recycle/reuse, but this recommendation has not been adopted by regulatory authorities. Indeed, NRC is prohibited by law from implementing a proposed generic policy on exemption of radioactive materials that was consistent with the NCRP recommendation. 

That documentation of pharmaceutical- and bio-equivalence should be provided to regulatory authorities is not at issue. However, the means by which these data can and should be demonstrated remain the subject of discussion. Political, economic and scientific hurdles pervade, and this issue remains unresolved. The imposition of existing small-molecule equivalence criteria on the registration of generic biologic drug products is unlikely to provide an acceptable degree of consumer protection. Likewise, the conventional bioequivalence trial used to infer therapeutic equivalence of different formulations based on the similarity of the phar-... 

In the guideline on SmPC the exact layout and the contents are defined. Additional guidelines issued by central bodies as well as national regulatory authorities provide recommended wording for specific text in various different classes of medical products in the jurisdiction of the RA (e.g. the MHRA document generic overdose sections for selected SmPCs, Feb 2004). 

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