Regulatory Approach to Stability Studies of Medicines in Bolivia
Q.F. Mary Carmen Chuquimia Socpaza
Quality Specialist & Regulatory Affairs Coordinator
SCR Consulting Bolivia
The safety and efficacy of medicines are influenced not only by their intrinsic properties, but also by their stability during the manufacturing process. Based on these premises, manufacturers and the Bolivian Medicines Regulatory Authority must work together to ensure that all medicines put into circulation in the Bolivian market have stability studies in order to establish their shelf life.
The stability of medicines depends on environmental factors, such as temperature, humidity and light, as well as product-related factors, among which outstanding are the physicochemical properties of the active ingredient and excipients, the pharmaceutical form and its composition, the manufacturing processes and the nature and properties of the packaging used.
The Medicines Regulatory Authority (“Agencia Estatal de Medicamentos y Tecnologías en Salud – AGEMED”) through the Guideline for Stability Studies of Medicines under Administrative Resolution No. 866 of October 15, 2020, indicates that it is the responsibility of the manufacturer, as part of the development of a medicine, to design and conduct adequate stability studies to gather reliable information, and to demonstrate how its quality varies over time, and under the influence of the storage conditions to which it is subjected. This information will allow proposing the period of validity during which it can be used with absolute safety.
Likewise, the manufacturer is responsible that the medicines maintain the quality during their permanence in the market, as long as they are distributed, handled, stored or dispensed by third parties in the Bolivian territory under the conditions required in the declared packaging and storage. For such purposes, medicine manufacturers may take as a reference the Guideline for Stability Studies of Medicines mentioned above.
The Medicine Regulatory Authority requests from the manufacturer data on the stability of the Medicine that supports the period of validity requested in the registration or re-registration of a pharmaceutical product. This information will be evaluated in the light of experience and current scientific evidence, which will allow it to approve the period of validity.
Stability Studies are part of the regulatory requirements established by the Bolivian regulations for the process of Sanitary Registration of new Finished Pharmaceutical Products (FPP) and those already marketed in the Bolivian national territory, whose development must be performed under environmental conditions at a temperature of 30ºC ± 2ºC and a Relative Humidity of 75% RH ± 5%, which correspond to the environmental conditions for climate zone IVb, established by the World Health Organization-WHO, for Bolivia; these conditions are excluded according to the guidelines for the development of stability studies of biological and biotechnological products.
According to the Manual for the Sanitary Registration of Medicines, approved by Ministerial Resolution No. 0909 dated December 07, 2005, in order to comply with this requirement, stability studies of at least 2 batches must be attached, and the corresponding protocols may be accepted only in the case of national products.
Likewise, the Stability studies of finished products may be presented in summary tables, indicating the parameters assessed, specifying the product, packaging, temperature and humidity conditions.
Only for new registration products and after evaluation, the Medicines Regulatory Authority may accept accelerated stability studies, granting a maximum shelf life of 24 months; for products corresponding to the re-registration process, it is mandatory to submit the stability studies at the environmental conditions for climate zone IVb.
Likewise, after evaluation, the Authority may accept the submission of Stability Studies under the environmental conditions for the climate zone IVa.
For the above mentioned, it should be taken into account that in terms of regulation, Stability Studies in Bolivia are not considered as a critical requirement, as it is, in High Sanitary Surveillance Countries, which are based on ICH standards and have special guidelines for Stability Studies, or as already dictated by the regulations in some Latin American countries, where Stability Studies become a mandatory requirement that allows among other requirements to obtain the sanitary registration. In Bolivia, the stability studies will be enough to mention, according to the regulations of this country that they are carried out under the environmental conditions for the climatic zone IVb, established by the World Health Organization-WHO.