On September 23, the National Health Surveillance Agency (Anvisa) board of directors published Public Consultation 1,282/24, which proposes criteria and procedures for the execution of commitment terms for issuance of marketing authorizations or post-marketing applications concerning medicines and biological products.

Contributions will be accepted between September 30 and November 13 of this year.

Rule

As a general rule, Law 6,360/76 establishes that quality, safety and efficacy aspects must be proven through scientific research so a company can obtain a marketing authorizations or post-marketing of medicines and biological products.

However, Anvisa and other international health agencies have constantly evaluated the positive and negative impacts of rejecting regularization requests – which can result in the non-availability of new treatments on the market – seeking to adopt a more risk-based approach.

In this sense, Anvisa recently published Anvisa RDC 911/24, which discusses whether is possible to include documents in an administrative appeal level against any decision rejecting a request to renewal a drug registration.

Situations that allow a commitment term

As drafted in the public consultation, the commitment terms will allow the subsequent submission of data and evidence in the following situations:

  • medicines indicated for rare diseases’ treatment, diagnosis or prevention, which are used in a serious debilitating condition and intended to change the disease’s progression in a clinically significant way or enable it to go into remission;
  • advanced therapy products, which comprise advanced cell therapy products, tissue engineering products, and gene therapy products;
  • public health emergencies, defined according to the national and international health regulations (IHR);
  • Post-registration requests: if a situation arises and requires additional evaluations or changes related to the extension of use, new therapeutic indication and co-administration with biological or synthetic medicine. For biological products used in the treatment or prevention of severe and/or high mortality diseases, significant therapeutic or preventive efficacy must be demonstrated – through relevant studies conducted according to ICH guidelines – and/or that there is no other comparable alternative therapy or drug for that stage of the disease; and
  • other situations defined in a specific normative act or previously and expressly authorized by Anvisa’s collegiate board of directors.

Requirements for signature

Registration or post-registration may be granted by a commitment term, provided that the following requirements are cumulatively met:

  • direct and potential benefits to public health outweigh any risks, considering the missing requirements criticality, the need for immediate availability, and the health context;
  • ensured sanitary control, inspection, and monitoring actions; and
  • no exemption of liability for the marketing authorization holder from complying with technical-sanitary requirements required on a permanent basis.

Procedure for signature

The marketing authorization or post-marketing authorization holder must submit:

  • justification for future presentation of data and evidence, with the corresponding risk assessment;
  • proposal for a commitment term that specifies the commitments to be assumed and their respective deadlines for compliance; and
  • Power of attorney with specific powers to sign the commitment term and any appendices.

Commitment term’s approval and execution will depend on the presentation of a favorable technical opinion from Anvisa’s technical area and the Federal Attorney's Office at Anvisa, as well as Anvisa’s collegiate board authorization.

The marketing authorization granted through a commitment term will initially be valid for three years and may be canceled in case of non-compliance with the commitments within the agreed deadlines or if it is found that it did not fit into the regulatory requirements.

The Life Sciences & Health practice can provide more information on the topic.