Missing the Target #5: Improving AIDS Drug Access ... - CD8 T cells

development and registration. Likewise, generic producers have invested toolittle to build their own regulatory competence. All too often, the prequalificationand registration files filed by generic companies are incomplete, delaying theprequalification and registration process (WHO Prequalification Programme, statusof product dossiers; Uganda).Lack of fast-track registration proceduresArgentina is an example of a country that has done a lot to streamline and expeditefollow-on registration processes. As described in its country report, both innovatordrugs and generic equivalents can be registered in Argentina via reliance on thefact of prior registration elsewhere. If prior registration has been granted by astringent regulatory authority, then Argentina will permit registration automaticallyupon presentation of a Certificate of Pharmaceutical Product. Alternatively, if theregistration has only been granted from an average authority, it must follow theordinary process (product, technical information, and labeling information and drugmonograph) plus it must submit a Certificate of Pharmaceutical Product from theregistering authority.However, the Argentina country report does not specify what happens in the eventof WHO prequalification. Thus an even better process, like that used in Belize andMalawi, would allow fast-track registration of WHO prequalified products and/orof products registered elsewhere by a stringent regulatory authority. Given weakregulatory capacity in many developing countries and problems of delay, it wouldmake sense for countries to modify their legislative and regulatory regime in orderto permit such regulatory reliance (Zimbabwe, China).Regulatory reliance of this form is slightly different than the normal process thatapplies to a follow-on generic equivalent. In this case, assuming that the originatorproduct has already been registered, and thus proved its safety and efficacy, allthat the follow-on producer must establish is the requisite degree of therapeuticequivalence, often based on evidence of bioequivalence, and the quality of themanufacturing process, often based on GMP certification. It behooves countriesto adopt clear and efficient guidelines permitting prompt registration of genericequivalents, even if they have not yet been WHO prequalified or registeredelsewhere by a stringent regulatory authority (China), so long as there is adequateevidence of bioequivalence, GMP, stability, and other data appropriate forabbreviated approvals. In this regard, WHO has provided some internationaltechnical assistance, especially on the tricky issue of registering fixed-dosecombination (FDC) equivalents to otherwise separately sold products. However,registration of FDCs remains problematic in some countries (China).Both regular and fast-track registration of generic equivalents might be delayed,however, if a country has improvidently adopted data exclusivity (a rule preventing adrug regulatory authority from referencing or relying on an innovator’s registration53