What is Brazil's CATEPEC?

Joint Ordinance 2 of September 09, 2024, which established the Technical Chamber for Clinical Research on Medicines and Medical Devices (CATEPEC) formally, was published by ANVISA on September 13, 2024. The purpose of the chamber is to support ANVISA's Coordination of Clinical Research in Medicines and Biological Products (COPEC) and Coordination of Clinical Research in Health Products (CPPRO) with technical and scientific expertise, thereby improving their capacity to oversee and assess clinical research pertaining to pharmaceuticals and medical devices.

Objectives of the CATEPEC

The main objective of CATEPEC is to support ANVISA in carrying out its regulatory and assessment duties. The chamber will make a contribution by providing professional assistance for the control and evaluation of clinical research, guaranteeing appropriate supervision of clinical trials.

To guarantee that the health authority keeps up with scientific and technical developments in healthcare, it seeks to modernize and streamline ANVISA's regulatory framework.

The objectives of the Technical Chamber for Clinical Research on Medicines and Medical Devices are:

• Provide technical-scientific support to the Coordination of Clinical Research on Medicines and Biological Products (COPEC/DIRE2) and the Coordination of Clinical Research on Health Products (CPPRO/GGTPS/DIRE3) of ANVISA, to fulfill their regulatory duties related to the regulatory and evaluation processes of clinical research on medicines and medical devices;
• Monitor scientific and technological development in health surveillance with a view to modernizing, rationalizing and streamlining ANVISA's regulatory actions in the health control of clinical research to support the registration and post-registration of medicines and medical devices;
• Promote the participation of the scientific community in the field of health surveillance and regulation through the exchange of knowledge and experiences.

Nature of Collaboration

As a collegiate body, CATEPEC brings together specialists with diverse expertise to bolster ANVISA's regulatory determinations. By standardizing external participation in clinical research-related regulatory decision-making, this collaborative approach improves the caliber of assessments for the approval and pos-approval of drugs and devices.

Thus, CATEPEC board will be made up of 9 professionals with a range of technical knowledge, experience and skills relevant to the evaluation of clinical trial protocols to support registrations and post-registrations. The members of the Technical Chamber for Clinical Research on Medicines and Medical Devices (CATEPEC) will be appointed by specific Ordinance for a term of 3 years.

In this way, according to ANVISA, technical subsidies from the Chamber will serve as a source of scientific evidence to improve the decision-making process within technical areas and standardize the participation of external agents in the decision-making process related to clinical research for regulatory purposes.

By establishing CATEPEC, ANVISA is better positioned to assess cutting-edge medical products, maintaining compliance with international regulations, and promoting technical advancements in Brazil's healthcare industry.

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