At a recent meeting, Anvisa presented to the regulated sector the main changes in the Collegiate Board Resolution (RDC) 954/2024, which revises the guidelines for the simplified drug registration procedure. They are the following
- RDC 954/2024 was published by Anvisa with the aim of defining the criteria for the simplified procedure including requests for the registration, post-registration and renewal of registration of generic, similar, specific and biological drugs that are linked to the technical and clinical reports of a parent petition for a drug already registered.
- The ‘clone’ procedure
- At the meeting, it was reported that this registration procedure, nicknamed “clone,” consists of a harmonization of decisions related to quality, safety, and efficacy documentation, which remain constant regardless of the dossier, as they are replicated in different registrations.
- In this way, with this procedure, there is a direct link to a drug that has already been registered, assuming that it will have the same clinical, technical, and quality characteristics as the original drug.
- It is a procedure that requires the submission of fewer documents and, as the name suggests, is simplified.
- The package insert texts
- The package insert texts may undergo variations. For example, if the parent drug is a generic and the “clone” is a similar drug, not only will the registration holder’s data be changed, but changes will also be necessary throughout the text, including the name of the drug.
- This approach helps to optimize the analysis, because, administratively, it allows for greater agility in the process, facilitating internal work and the evaluation of new registrations.
- Administrative responsibility
- In terms of administrative responsibility, it is essential that the company knows its product well, that is, the medicine under its ownership, the registration for which it is responsible.
- By having access to the dossier of the parent medicine, the company can fulfill its administrative responsibility, ensuring that every product submitted to Anvisa which receives a medicine registration number is in compliance.
- In this sense, the RDC defines two important issues:
- knowledge and full access to the complete and updated dossier of the parent drug by the holder of the “clone” registration; and
- the submission of the complete dossier or parts thereof, when requested by the Agency, is the responsibility of the holder of the “clone” registration.
Source: Anvisa