Such decree, entered into force on 11 January 2021, aims to establish the regulatory provisions of the Article 8 from Law N° 29459, Law of Pharmaceutical Products, Medical Devices and Health Products, modified by Law N° 31091, to regulate the conditional health registration of medicines and biological products with phase III clinical studies.

In general terms, the regulation describes the general dispositions; criteria to comply with the registration; label and data sheet; documentation including preclinical and clinical studies; suspension, modification or cancellation of the conditional health registration; obligation to follow a pharmacovigilance system according to the current Manual of Good Practice; compliance for the storage and distribution; and measures about the security of the general population, infringements and penalties.

Editors Comments
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘productos biológicos similares’ approved in Perú might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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