pharmaceutical industry

Vocabulário Controlado de Formas Farmacêuticas, Vias de Administração e Embalagens de Medicamentos

"A Anvisa divulga (...) o Vocabulário Controlado de Formas Farmacêuticas, Vias de Administração e Embalagens de Medicamentos. A publicação ficará disponível no portal da Agência, no link 'Medicamentos'. O livreto contém a padronização das nomenclaturas e conceitos relacionados às formas farmacêuticas, vias de administração e embalagens de medicamentos para serem utilizados como referência primária, principalmente no registro e pós-registro de medicamentos. Outro aspecto importante são as abreviações das características técnicas, muito utilizadas em publicações oficiais.

"Anvisa publishes (...) the Controlled Vocabulary of Pharmaceutical Forms, Pathways of Administration and Packaging of Medicines." The publication will be available on the Agency's website, under the link 'Medicamentos.' The booklet contains the standardization of nomenclatures and concepts related to Pharmaceutical forms, administration routes and packaging of medicinal products to be used as a primary reference, especially in the registration and post-registration of medicines.Another important aspect is the abbreviations of technical characteristics, widely used in official publications.

MedDRA

"In the late 1990s, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed MedDRA, a rich and highly specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical products used by humans. ICH’s powerful tool, MedDRA is available to all for use in the registration, documentation and safety monitoring of medical products both before and after a product has been authorised for sale.