On May 17, 2022, Decree No. 011-2023-SA was published in the Official Gazette "El Peruano," approving the regulation that governs the presentation and content of the documents required for the registration and re-registration of biological products: Other biological products.
The purpose of this regulation is to establish the information and rules that regulate the presentation of the documents required for the registration and re-registration of biological products in accordance with the recommendations of the World Health Organization (WHO), the Pan American Network for Drug Regulatory Harmonization (PANDRH), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the European Medicines Agency (EMA), the General Directorate of Health Products and Foods of Canada (Health Canada), the Food and Drug Administration of the United States (US FDA), and/or other Regulatory Agencies of Countries with High Health Surveillance. The documentation must be presented in accordance with the Common Technical Document (CTD).
For more details on the regulation, please check the following link: https://busquedas.elperuano.pe/normaslegales/decreto-supremo-que-aprueba-el-reglamento-que-regula-la-pres-decreto-supremo-n-011-2023-sa-2178398-1/
If you require more information, please send us an email at tmamani@tmtabogados.com or through our digital channels: Contact us