On February 16, 2022, the National Health Regulatory Agency (ANVISA) published Resolution RDC No. 601, of February 9, 2022 (“RDC No. 601/2022”), which provides for the simplified analysis of petitions for consent in the clinical research process, on an exceptional and temporary basis.
The objective of this measure is to make the procedure for releasing petitions for consent faster and more efficient, in light of the current pandemic scenario.
We highlight below the main innovations introduced in the new legislation:
- Scope: the Resolution expands the scope of application analysis for the initial Specific Clinical Trial Dossiers (DEECs) and to include a protocol for all clinical indications, not just for Covid-19 and rare diseases. In addition, it also encompasses Service Guide No. 104/2021 (which provides for the detailing of the analysis procedures required for filing of the Development Dossier) and adjusts the procedure for good regulatory practices.
- Requests that will have simplified analysis: the simplified analysis will occur for the following petitions: (i) Consent in the Clinical Research Process; (ii) Modification of Clinical Drug Development Dossier (DDCM) – Inclusion of Clinical Trial Protocol; (iii) Modification of DDCM – Change that could potentially impact the quality or safety of the product under investigation; (iv) Substantive Amendment to the Clinical Protocol; and (v) Consent in the Process of the DDCM, referring to the Experimental Drug Dossier.
- Use of analyses carried out by a foreign regulatory authority: the simplified analysis must be carried out for cases in which the petitions have been approved by (i) the regulatory authority of at least one founding member country (Founding Regulatory Members) or a permanent member country (Standing Regulatory Members) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH); or (ii) by the UK regulatory authority (Medicines and Healthcare products Regulatory Agency MHRA).
- Validity: the validity of this RDC will automatically cease 120 days after an act of the Ministry of Health enters into force, establishing that there is no longer a public health emergency. Finally, it is worth clarifying that a specific queue will be created for petitions that fall within the scope of this DRC.
Demarest’s Life Sciences Team continues to monitor activities in the sector and is available should you need any further clarification on this matter.