- Aruna Asesores
- +57 315-6012347
- 4271544
- info@arunasesores.com
- Aruna Asesores
- +57 315-6012347
- 4271544
- info@arunasesores.com
Menu
*With our services, marketing authorizations are achieved in the countries where we operate, we provide regulatory services, we do not manufacture products
In Peru, the entity in charge of providing access to safe, effective and quality medicines is the General Directorate of Medicines, Supplies and Drugs (Digemid), a line agency of the Ministry of Health (Minsa). Thus, the Digemid health agency has the function of guaranteeing the quality of pharmaceutical products, medical devices and health products, which are in the national market, for this it executes control and surveillance actions in the processes related to production, import, storage , distribution, commercialization, donation, promotion, advertising, dispensing and sale of these.
Within this category, not only synthetic medicines are considered, but also biological, biotechnological, homeopathic and herbal medicines.
Aruna Asesores Perú SAC has a team of professionals who analyze in depth the needs of each particular case regarding Sanitary Registration of medicines, thus reducing the risks of failed launches and promoting correct decision-making in the shortest term.
The biological product contains a biological substance that is produced or extracted from a biological source and that requires, for its characterization, determination of its quality, a combination of physical-chemical and biological tests together with the production process and its control.
It is a biological product registered and marketed in Peru or in countries with high sanitary surveillance or in the EMA, with complete data on quality, safety and efficacy, which is used as a comparator in comparability studies on equal terms with the biological product. similar, in order to demonstrate similarity.
The PBR does not refer to measurement standards such as international, national or pharmacopoeial standards or reference standards.
It is a biologic that, in terms of quality, safety, and efficacy, is similar to a biologic reference (RBP). To request the sanitary registration of biological products that opt for the similarity route, it is necessary to adhere to the recommendations of the World Health Organization (WHO), Red PANDRH, ICH, EMA, Health Canada and/or FDA, or other authorities. that are established by supreme decree endorsed by the Minister of Health and the Minister of Economy and Finance, at the proposal of the National Health Authority (ANS). Currently, health regulations do not contemplate the assumptions of interchangeability or therapeutic substitution.
Consequently, the interchangeability of a biological drug in Peru requires a specific legal framework and scientific demonstration to support that the same clinical result will be obtained as the reference product in any patient and that there is no risk in terms of safety or decrease in efficacy of switching between biosimilar and reference
At Aruna Asesores we have an expert technical and legal team in this category willing to advise you on what clients require.
We offer the following services:
Check with our professionals online or get frequent questions about registration processes in different countries
Check with our professionals online or get frequent questions about registration processes in different countries
