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RDC 753 - New Regulatory Framework for the Registration of Synthetic Drugs.



What are the points of greatest impact?


After a wait of more than 2 years, the RDC 753, which regulates the registration of synthetic medicines, was finally published on October 5, 2022 and replaced the RDC 200/2017.

The most significant changes involve the creation of new registration routes and modifications in the methods for demonstrating safety and efficacy, while the technical content of the dossier remains largely unchanged.


The new standard retains the 3 types of records found in RDC 200/2017:


Generics and similar: did not change.


New drug: maintains the classification of new molecules and includes the Registration of a new analogue Active Pharmaceutical Ingredients (APIs). This registration applies to drugs with at least one new API in the country and analogue to the API of an already registered drug, which was previously classified as innovative.


Innovative medicine: only includes new packaging within this category, while retaining the other classifications such as new combination, new monodrug, new route of administration, new concentration, new pharmaceutical form, new therapeutic indication or those with different innovations compared to new medicines already registered in the country.


One significant change is the introduction of Development Paths:


Complete Development Route: applies to the application for registration of a new or innovative drug in which the information necessary to prove the safety and efficacy of the drug proposed for registration comes from studies conducted by or for the applicant, and for which they must full reports (non-clinical and clinical phase I, II and III) must be submitted.


There are exceptions for new drugs that may qualify for the abbreviated development pathway:


· I - Medication for a serious debilitating condition, which demonstrates an unmet medical need.


· II - Medication used in the context of public health emergencies.


· III - Medicine for rare, neglected, emerging or reemerging diseases.


· IV - Prescription medication registered and marketed for over 10 years by regulatory authorities with technical requirements similar to those adopted by ANVISA.


· V - Medicine with an API similar to the API of an already registered medicine, in cases where it is demonstrated by the registration applicant that there are no significant differences in the safety and efficacy profile between the medicine being proposed for registration and the medicine already registered that preclude the use of existing data or, in the case of any differences, that these are duly justified and scientifically based in order to enable the use of existing data; or


· VI - Medicine with an API of a previously registered medicine in the country, even if the registration is no longer valid.


· Abbreviated development route: applies to the application for registration of a new or innovative drugs, where some of the necessary information to prove the safety and efficacy may come from studies not conducted by or for the applicant. In this category, such evidence can be accepted for safety and efficacy demonstration.


- I - Clinical studies.


- II - Non-clinical studies.


- III - Bridge studies: study conducted with the purpose of establishing correlations between drugs or populations in order to allow the extrapolation of efficacy and safety data.


- IV -Scientific literature; or (only accompanied by bridge study).


- V - Technical data.


The inclusion of the abbreviated route was the central change of the new resolution, which offers greater flexibility in proving safety and efficacy since, unlike RDC 200/2017, it does not establish a fixed list of studies to be presented. Therefore, it allows the establishment of a technical-scientific and clinical rationale to base the development of the medicine.


Nevertheless, this change imposes on the developing companies the responsibility of choosing, basing and guaranteeing that the indicated studies and data are sufficient to carry out the extrapolation of data from the medicine that conducted the complete clinical development. This will require in-depth knowledge about the product to be developed, the disease to be treated and the expertise to design studies that effectively fulfill the objective.


To assist companies in understanding expectations, ANVISA will imminently release the final version of the guides:


· The submission of the registration of synthetic and semi-synthetic medicines through the abbreviated development route.


· Submission of registration of synthetic and semi-synthetic drugs through the full development route.


· Submission of synthetic and semi-synthetic drug registration based on scientific literature data.


We previously published the draft of the standard on our blog in November 2020. CHECK IT OUT


We hope that this new regulatory framework for the registration of synthetic drugs, which aligns Brazilian and international legislation, will provide Brazil with a leap forward in the development of innovative drugs.


Please review the COMPLETE ANVISA GUIDE titled “Submission of registration of synthetic and semi-synthetic drugs through the complete development route”.

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