Regarding the understanding of the rule that deals with the conditional approval of post-registration petitions for drugs (RDC 219/2018), Anvisa informs companies about its recent amendment. Subjects related to pharmaceutical technology and active substance of biological products were included
According to the resolution, post-registration applications for drugs whose analysis period has ended without having started the analysis by the Agency should have their approval published on a conditional basis. However, with regard to biological products, there was an exception, according to the provision in Article 4 of the RDC 219/2018:
Art. 4º The petitions for changes for drugs and biological products post-registration that await Anvisa’s evaluation may be subject to conditional approval, provided they meet the following requirements:
I – are instructed with all the documentation required by health regulations;
II – that all the required tests are duly self-analyzed and approved by the company, according to the guidelines of the health regulations;
III – contain a risk assessment carried out by the applicant company, with regard to ensuring the maintenance of the quality, efficacy and safety of the drug in the face of post-registration amendments;
IV – the technical analysis by Anvisa has not been initiated;
V – are not pending a decision on appeal;
VI – no safety and efficacy report is required under this
Resolution.
- 1º The conditional approval will not apply when there is a change parallel to another post-registration amendment for which a safety and efficacy report is required, in accordance with this Resolution.
- 2º The conditional approval will not apply to post-registration changes related to the production process and/or manufacturing location of the active pharmaceutical substance of biological products sold under medical prescription. (emphasis added)
Thus, when considering post-registration issues for conditional approval, all those related to pharmaceutical technology (quality) of the active substance of biological products are excluded, under the understanding that they would be directly or indirectly related to the production process. The protocol of the respective addition was not considered necessary as matters relating to the active substance of biological products would not be covered by the conditional approval.
However, there was a recent change in this understanding and, thus, numerous post-registration issues that were related to the quality of the active substance of biological products succeeded in being framed as subject to conditional approval by RDC 219/2018. The above items are described in the Technical Note 63/2018, published on November 7, 2022, on the ANVISA portal.
Taking into account this change of understanding, it is necessary to warn that the additions to RDC 219/2018 for matters related to the quality of the active substance, currently contemplated and publicized by Technical Note 63/2018, need to be filed as soon as possible in the form of the specific addition of the aforementioned RDC (subject code 11322 – BIOLOGICAL PRODUCT – Addition – Conditional approval – RDC 219/2018).
In the meantime, it should also be noted that the absence of a protocol for the aforementioned amendment when Anvisa missed the deadline for the start of the analysis leads to the summary rejection of the petition, in accordance with the provisions of Article 7, § 2°, of RDC 219/18.