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ANVISA’S new era: is the regulatory sector prepared for this?




In recent times, the regulated sector has watched with great satisfaction ANVISA's reinvention; going from little contact with the regulated sector, unable to meet legal deadlines, with gigantic lines of analysis and an isolation regarding the adoption of its own standards unparalleled in international documents, to a dynamic agency open to dialogue, which practically ended the queue of drug registrations and, as members of the ICH, started to accept documents prepared based on the technical concepts adopted by this international body.


But what has changed at ANVISA?


The first and most important change was their mindset. ANVISA adopted the working model for the creation of rules and decisions in conjunction with the regulated sector and demonstrated transparency in the clear disclosure of technical requirements charged in registration and post-registration and progress of the processes. Good examples of this are:


Dialogue through technical meetings and constant meetings with associations representing the productive sector.


Sharing responsibilities with the regulated sector through PATE.

Exchange of information with the regulated sector, the “DRs” with the regulated sector initiated by Dr. Jarbas Barbosa is a great example.


Thematic workshops for convergence on complex topics such as the recent Forum on Advanced Cellular Therapy Products focusing on CAR-T cells.


Introduction of the regulatory impact assessment methodology for the publication of new standards, bringing a large participation of the regulated sector in the discussion and evaluation of the new standards with an assessment of the consequences they will have on the companies' daily lives. The new rules on dietary supplements were a regulatory framework in the way of driving changes in legislation.


Development of themed guides for guidance on specific topics and the recently launched thematic library of standards.


Other equally important changes were the great focus on improving and optimizing internal processes and the health risk criterion to guide decisions, as well as innovation in the way of working with the adoption of remote work with defined KPIs, continuous training and the search for the integration of the areas.


All of these good practices have brought impressive results, such as compliance with legal deadlines and the significant reduction in medication registration queues; and today we are significantly close to achieving the big dream of the regulated sector, which is the predictability of processes at ANVISA.


Moreover, only this year, in addition to the regulatory framework for food supplements, ANVISA published the new rules for registration of dynamized products, modernized the rules for outsourcing, extended the deadline for renewing health products according to risk and implemented conditional approval. of post-registration that was another old dream of the regulated sector.


There are still points for improvement, but ANVISA, even with limited resources, is being able to revolutionize its processes and increase its efficiency, putting an end to the phase where it was guilty of most of the delays in the pharmaceutical sector.

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