Anvisa has published the Common Technical Document (CTD) Guide for the Registration and Post-Registration of Medicines. The material sets out the format and structure that companies can follow for preparing and submitting dossiers submitted to the Agency. The Guide includes applications for registration and post-registration of new, innovative, biological, generic, similar, radiopharmaceutical, specific and herbal medicines.

With this guide, Anvisa will implement the International Harmonization Council (ICH) M4 Series Guides. “This publication is an important milestone for the Agency, which, by becoming a regulatory member of the ICH, made a commitment to implement the M4 Guides by November 2021,” explains Anvisa Director Alessandra Bastos.

The International Council for the Harmonization of Technical Requirements for the Registration of Medicinal Products for Human Use (ICH) brings together regulatory authorities and pharmaceutical industry associations to discuss the technical and scientific aspects of the registration. of medicines. Adoption of the CTD format is estimated to reduce the time and resources needed to evaluate drug registration and post-registration.

Composition and Contribution

Anvisa's CTD Guide consists of five files: General Guide, which deals with protocol and granularity, and four attachments. The annexes cover Module 1 - Regional, prepared by Anvisa, and modules 2 to 5, already pre-established by ICH.

The preparation of the CTD Guide was based on the original documents of the ICH and counted on the contribution of the Brazilian productive sector and the experience of Anvisa's technical team. The document will now be open to contributions from society as a whole for a period of six months.