ANVISA – Resolution RDC 753/2022 – Review to RDC 200/2017 – Marketing Authorization of New, Innovative, Generic and Similar Medicinal Products – updated on October 10th, 2022

On October 7, at Public Ordinary Meeting ANVISA 19/2020, it was approved the draft for Public Consultation of new legislation to review the requirements for proof of safety and efficacy of new and innovative drug products (current RDC 200/2017, which provides on the criteria for approval and renewal for the marketing authorization of drug products with synthetic and semisynthetic active ingredients, classified as new, generic and similar).

This Public Consultation draft was considered a new regulatory framework regarding the simplification of the drug product marketing authorization process in Brazil, ensuring greater agility and expansion of therapeutic options for safe and effective drug products.

In order to reach this proposal, ANVISA established a Working Group (WG) to review the RDC 200/2017 and analyzed the ways of authorization for new/innovative and generic drug products in Brazil (Anvisa), USA (FDA), and Europe (EMA).

The final proposal aims to review the current procedure of Anvisa that stipulates a fixed list of documents to be submitted by category of medicines, starting to use the rationale also based on the models of the agencies EMA and FDA. By using supporting documents of safety and efficacy for easing the marketing authorization processes, there will be the possibility of submitting a new or innovative drug product dossier in an “abbreviated” term already used by other agencies and incorporated in the WG.

On 23 October, Public Consultations (CPs) were published in the Brazilian Official Gazette (DOU) to review the requirements for proving the safety and efficacy of new and innovative medicinal products brought by Anvisa’s RDC 200/17.

Check below a summary that we have prepared on the main changes brought by the CP drafts.

– CP 931/2020:

Proposal for the preparation of a Normative Instruction with the objective of guiding the regulated sector on the administrative protocol for marketing authorization requests, clearly defining the subject codes, in order to facilitate the framing of petitions submitted to Anvisa. This proposal describes all matters related to the marketing authorization of new and innovative medicinal products, as well as the justification for each one of them. See below the list of subjects covered by the CP draft

Marketing Authorization of:

  • new medicinal product;
  • new pharmaceutical form in the country;
  • new strength in the country;
  • new therapeutic indication in the country;
  • new route of administration in the country;
  • new association in the country; and
  • medicine with diverse innovation.

According to ANVISA, the choice of Normative Instruction (NI) as a Regulatory Instrument is because incremental innovations may arise that may not currently be foreseen. As a result, it is more appropriate for this topic to be regulated in an NI, since its review has a more simplified procedure, without the need to completely revise the RDC.

– CP 932/2020:

Deals with the review of the requirements for proving the safety and efficacy of new and innovative medicines and brings as a major innovation the creation of two Development Pathways for obtaining clinical and non-clinical information to be presented in the application. registration: the complete development path and the abbreviated development path.

In the registration through the full development route, the non-clinical and clinical data must come from studies conducted by or for the applicant of the application with the medicinal product with the API that is being proposed for registration. The applicant must retain the reference rights of the data and access to raw data from all studies presented.

In the marketing authorization by the abbreviated development route, the non-clinical and clinical data may come from sources other than the studies conducted by the applicant. To accept data from studies not conducted with the medicinal product that is being proposed, it is necessary for the applicant to present bridge studies that allow the extrapolation of the existing data for the medicinal product being proposed.

It is worth mentioning that, as each medicinal product has its specificities, the proposal foresees that the choice of the development path and the decision for which studies are necessary will be discussed with Anvisa even during the development of the product since the proposal for regulatory flexibility will be based on the health risk of each product.

Anvisa also informs that for both registration routes, specific guidelines have been elaborated that describe in detail the requirements of each one and still contain the list of evidence and models discussed worldwide that will be accepted for proof of effectiveness and safety. These guidelines were published on the ANVISA’s website as a Directed Consultation together with the Public Consultation proposals.

The CP draft also provides details on the documents that must be presented to prove safety and efficacy in the dossier of registration of the medicinal products categorized as New and Innovative, which are:

  • Reports of non-clinical and clinical studies that contain minimally:
    • non-clinical pharmacological and toxicological characterization; and
    • biopharmaceutical, pharmacological, safety, and efficacy clinical characterization;
  • Clinical rationale for medicinal product development, presenting the advantages of the product that is being proposed for marketing authorization  in view of the therapeutic options already registered;
  • Contextualization of the clinical condition for which the medicinal product is intended, including the therapeutic options existing in Brazil, discussion of clinical practice, and national epidemiological data, when available;
  • Evaluation of the benefit-risk ratio, with integrated critical analysis for the proposed medicinal product under the conditions of use, claimed, considering the safety and efficacy data presented; and
  • Risk Management Plan, prepared in accordance with the specific regulations in force.

Remembering that these documents can be prepared based on the data obtained in both development paths.

For new and innovative medicinal products that contain a combination of two or more APIs, in addition to the documents mentioned, the following data must also be presented:

  • Evidence of the clinical relevance of the role of each of the APIs in the clinical indication requested for the association;
  • Information about pharmacokinetic and pharmacodynamic interactions between the APIs that make up the association;
  • Technical justification with the clinical and pharmacological rationale of the association that demonstrates:
    • increase in the safety or efficacy of the APIs association, due to the additive or synergistic pharmacological activity or by reduction of resistance; or
    • minimizing the potential for abuse; or
    • improving the bioavailability of the main API; or
    • simplification of the therapeutic regime.

It is worth mentioning that the technical quality requirements and the specific requirements for registration of generic and similar medicinal products in RDC 200/2017 are not under discussion in this Public Consultation, as they are being dealt with in another regulatory process, together with the review of RDC 73/2016. This CP is expected to be published in December/2020, and the publication of the final text of the review of RDC 200/2017 will await the completion of this other regulatory process.

The deadlines for contributions to these CPs are 29th December 2020, through the specific form on the ANVISA website. (updated on 19th November 2020)

Access the publications in full through the links:

Access the Development Path Guidelines through the links:

On September 28, 2022, at the 18th Ordinary Public Meeting of the Collegiate Board of Directors of ANVISA (Dicol), the draft Resolution for the review of RDC 200/2017, regarding the requirements for the safety and efficacy of new and innovative drug products, as well as the draft of Normative Instruction to provide the subject codes for applications related to Marketing Authorization applications for new and innovative synthetic and semi-synthetic drug products, derived from public consultations (CPs) 931/2020 and 932/2020, respectively, have been approved.

According to the vote presented by the process writer, Dr. Meiruze Freitas, the proposal to review the requirements for the safety and efficacy of new and innovative drug products in RDC 200/2017 aims at harmonizing and expanding the sources of information to be presented, allowing the exemption of the already known data of an API. For this, it is expected that the replication of clinical and non-clinical studies that are not scientifically necessary is avoided, and also that the alignment of national and international requirements is promoted, resulting in greater interaction between the Pharmaceutical Industries and ANVISA.

It is important to mention that the technical quality requirements and the specific requirements for MA of generic and similar drugs (Section III of Chapter III, Chapter IV, and definitions related to these chapters) of RDC 200/2017 were punctually adjusted in this proposal, not being the focus of this review.
It is expected that the new Resolution will be published soon, including the new requirements for safety and efficacy for new and innovative drug products.

Access the link and check out the complete vote of the process writer: (only in Portuguese)


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