ANVISA – Publication of new regulation to expand clinical trials with medicinal products in Brazil

On November 3rd, 2021, ANVISA published the Resolution of the Collegiate Board of Directors – RDC 573/2021, which changes, urgently and temporarily, the RDC 9, of February 20th, 2015 (which regulates the conduction of clinical trials in Brazil).

In order to reduce the waiting time for the Agency to express its opinion on the authorization of new researches, the new regulation allows for the use of analysis carried out by foreign authorities which are founding or permanent members of the ICH (International Council for Harmonization of Technical Requirements for Pharmaceutical Products for Human Use).

Due to the new coronavirus pandemic, the technical area responsible for the analysis of clinical research focused its efforts on matters related to pandemics, which consequently generated an increase in the Agency’s waiting time for clinical research related to other diseases.

With this change in the regulation, the Agency now considers the period of 120 calendar days for opinion, applicable to every Drug Product Clinical Development Dossier (DDCM, as the acronym in Portuguese) involving clinical research with national clinical development, biological products clinical development (including vaccines) and clinical development in phase I or phase II.

If the opinion on the DDCM is not issued within this period, the Agency will issue a Document for the Import of Product(s) under investigation for the DDCMs that have one or more studies approved by at least one regulatory authority from at least one founding or permanent member country of the ICH or by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA), and clinical development may commence after relevant ethical approvals. This rule does not apply to vaccines’ DDCMs, which clinical development may only be started after analysis and consent by Anvisa and the relevant ethical approvals.

This change in procedures also applies to DDCMs already received by ANVISA and whose review has not yet started.

Attention! In order to comply with the described in §1 and 2 of art. 36-A of RDC 9/2015, as altered by RDC 573/2021, the company should submit the subject code “1363 – ENSAIOS CLÍNICOS – Aditamento”, containing the Official Document issued by the foreign authority or a declaration of compliance fulfilling the criteria described in the said provision.

This rule ceases being valid after 120 days from the entry into force of an act of the Ministry of Health that recognizes that the public health emergency of national importance, declared by Ordinance 188/GM/MS on February 4, 2020, is over.

Count on Vita to assist your company in developing drug products registration and post-registration projects in Latin America.