Boletim Kestener & Vieira Advogados
Temporary criteria and procedures for register and post-register application of medicines, biological products and API, based on foreign regulator analysis
On 8 September 2022, the National Health Surveillance Agency (Anvisa) published Resolution No 750/2022 (Portuguese language) which provides for temporary criteria and procedures for register and post-register application of medicines, biological products and active pharmaceutical ingredients, based on the analysis conducted by an equivalent foreign regulatory authority.
The new Resolution aims to simplify and optimise the evaluation of register and post-register applications based on results obtained by foreign regulatory authorities, allowing companies approved for more than one of the accredited authorities to choose which one should be adopted as a reference before Anvisa.
According to the Resolution, the results of the following foreign authorities can be considered for the optimised procedure:
- European Medicines Agency: with regards to medicines and biological products.
- Health Canada: with regards to medicines and biological products.
- World Health Organization: with regards to medicines and active pharmaceutical ingredients.
- European Directorate for the Quality of Medicines & HealthCare: with regards to active pharmaceutical ingredients.
- Swissmedic: with regards to medicines.
- UK Medicines and Healthcare products Regulatory Agency: with regards to medicines and biological products.
- US Food and Drug Administration: with regards to medicines and biological products.
Through its many provisions, the new resolution sets forth that:
- To be eligible for the optimised procedure, the active pharmaceutical ingredient, medicine or biological product must have been previously approved by at least one of the listed equivalent foreign regulatory authorities.
- The optimised procedure will not affect the chronological order of the register or post-register applications.
The new Resolution entered into force on 19 September 2022 and is valid for 180 days from the date of its entry into force.
Anvisa updates criteria regarding bioequivalence/relative bioavailability studies
On 8 September 2022, the National Health Surveillance Agency (Anvisa) published Resolution No 749/2022 (Portuguese language) regarding bioequivalence/relative bioavailability studies.
According to the Resolution, new and innovative medicines are exempt from bioequivalence/relative bioavailability studies in the following hypothesis:
- For concentrations in relation to the demonstrated in vivo bioequivalence, in cases where the other proposed concentrations are within the approved therapeutic range.
- In cases of post-registration changes, based on (i) the biopharmaceutical classification system and (ii) on pharmaceutical form, route of administration or site of action (except changes related to dosage, expansion of use, inclusion of a new route of administration, new indication and inclusion of a new concentration for new drugs, as described in Resolution No 73/2016 (Portuguese language).
Other scenarios may be accepted upon prior consultation and presentation of a technical justification. In any case, interested companies must submit a specific report during the registration/post-registration process.
The new Resolution entered into force on 3 October 2022 and revokes Resolution No 37/2011 (Portuguese language), Normative Instruction No 10/2016 (Portuguese language), article 26, I, of Resolution No 31/2010 (Portuguese language) and article 12 of Resolution No 278/2019 (Portuguese language).
Anvisa updates list of Brazilian Common Denominations
On 8 September 2022, the National Health Surveillance Agency (Anvisa) published Resolution No 748/2022 (Portuguese language) regarding the list of Brazilian Common Denominations (known as DCB).
Approved by Resolution No 469/2021 (Portuguese language), the list of Brazilian Common Denominations, which establishes the names of medicines and active pharmaceutical ingredients approved by the federal agency responsible for health surveillance (Law No 9.787/1999) (Portuguese language), has been regularly updated by the Thematic Technical Committee on Brazilian Common Denominations, instituted by Anvisa in 2001.
The use of the DCB facilitates the correct identification of supplies, as well as medicine interchangeability, and has been mandatory in medicine registration dossiers, labelling, advertising text, bidding processes, documents related to the manufacture and market of active pharmaceutical ingredients, since the publication of Law No 6.360/1976 (Portuguese language), which institutes the DCB as the official denomination used in Brazil.
The new Resolution, which entered into force on 8 September 2022, includes 13 new nomenclatures, and changes the denomination listed in Annex II, regarding Gatifloxacin (DCB No 04407).
The new resolution entered into force on 8 September 2022.
The updated list of DCBs is available on the official website of Anvisa.
Practical Law with the permission of the publishers. For further information visit https://uk.practicallaw.thomsonreuters.com
