Drug and pharmaceutical activity of the regulatory issues are characterized by high public interest. Protection of high quality, safe and effective drugs is available by creating accurate regulatory model.
The World Health Organization (WHO) considers the regulation of the drugs and pharmaceutical activities as a major challenge for developing countries and urges countries to ensure the efficient regulation of this sector by determining and improving deficiencies in regulations.
Under these circumstances, it is crucial to thoroughly study the regulation system of quality, safety and efficacy of the pharmaceutical products.
The audit studied the drug and pharmaceutical regulatory system, pre and post-market control measures of pharmaceutical product.
The main audit findings are:
› Pharmaceutical activities, namely: manufacturing, clinical trials, pharmacy practice falls behind internationally recognized practice and standards;
› The specialized pharmacies where the sale of prescription pharmaceutical products is allowed do not require a permit. 72% out of the total number of pharmacies are specialized pharmacies. Consequently, for functioning the most important part of pharmacies conditions and criteria are not defined. In addition, there are no sanctions identified for the violation of sanitary or hygiene norms;
› The scope of the drug authorization is restricted by legislation. There are shortcomings in national and recognition authorization procedures that have impact on proper quality control of pharmaceutical product;
› Marketing authorization by recognition procedure – unilateral recognition mechanism does not ensure elimination of risks connected to pharmaceutical product by intercourse of recognized regulatory agencies. The agency does not ensure the permanent monitoring of the web sites and connection with other regulatory agencies when it is necessary. After the authorization, the regulatory agency may also have delayed response to remove unsafe and ineffective pharmaceutical products from the market, which were removed by “recognized” country or by interstate regulatory agency;
› According to Georgian legislation, protecting all types of quality standards is not considered. During national marketing authorization, control of quality, efficacy and safety of pharmaceutical products are not ensured under the current regulations by the following mechanisms:
- Submitting the information about the side effects of the generic pharmaceutical products;
- Preliminary laboratory control of pharmaceutical products;
- Use of in vivo bioequivalence method;
- Submitting information about the validity of the methods of analysis.
› Authorization process of pharmaceutical product is simplified in Georgia. This is corroborated by the fact that the number of authorized pharmaceutical products is high (10 541) and 35% of authorized medicines (2011-2012) has not been imported in the country yet (the end of audit period). Accordingly the purpose of market authorization was not the realization of the pharmaceutical product in Georgian market;
› Permission conditions are mostly inspected in authorized pharmacies, which sell pharmaceutical products under special control. Despite frequent violations abolished pharmacies continue functioning with different legal status. Therefore, huge resources of inspection division are spent on the control of activities that cannot be prevented under the current regulations;
› Informational environment of the agency cannot ensure complete and precise identification of risks;
› Pharmacovigilance system is not developed. Information sharing mechanisms with patients, medical personnel, organizations involved in pharmaceutical activities, NCDC are not established. These mechanisms are necessary for monitoring, eliminating and preventing adverse drug reaction and the side effects of pharmaceutical products.
State Audit Office has issued recommendations that will eliminate existing problems and will improve the system.
