INFO KGV | LIFE SCIENCES MAY 2021

Anvisa implements standards and proceedings for improvement of regulatory quality

On 15 March 2021, the Brazilian Health Surveillance Agency (Anvisa) published Ordinance No 162/2021 (Portuguese language) regulating the standards and proceedings for the improvement of regulatory quality within the Agency.

The guidelines and procedures in the Ordinance must be observed in the planning, preparation, implementation, monitoring, evaluation and review of regulatory instruments. They may be also applied to other acts with an impact on the quality of Anvisa’s regulatory activity at the discretion of the Board of Directors.

Improvements to regulatory quality must adhere to certain principles including, among others: (i) regulatory action based on health risk to protect the health of the population; (ii) regulatory coherence and convergence; (iii) evidence-based regulation; (iv) regulatory predictability; (v) promotion of a regulatory environment favourable to social and economic development; and (vi) reduced bureaucracy, increased speed and administrative simplification.

To achieve these principles, the Ordinance sets forth the following procedures:

• Analysis of regulatory impact (AIR) to enable assessment of a regulatory problem prior to the publication of normative acts of general interest. The analysis should contain information and data on the act’s likely effects to verify its reasonableness and support decision-making.
• Regulatory result assessments to verify the impact of a normative act, considering whether its implementation has achieved its intended objectives and other impacts on the market and society.
• Public hearings carried out in face-to-face or virtual public sessions, where interested parties make written or oral submissions debating proposals for normative acts, documents or relevant matters of interest to Anvisa.
• Monitoring and evaluation of regulatory results to collect information on performance of the regulations and the ARR, among other instruments.

The Ordinance’s provisions will take effect for all administrative regulation processes initiated as of 1 April 2021.

COVID-19: standards for emergency use of drugs

By Kestener & Vieira Advogados

 On 12 May 2021, the Brazilian Health Surveillance Agency (Anvisa) published Guide No 49/2021 (Portuguese language) which regulates standards regarding requests for temporary authorisation for emergency use of drugs for COVID-19.

The Guide contains the minimum technical requirements, in light of Resolution RDC No 475/2021 (Portuguese language), to be submitted by companies for requests for emergency use, notably:

• Implementation of good pharmacovigilance practices systems as provided for in Resolution RDC No 406/2020 (Portuguese language), which requires drugs manufacturers to detect, assess and prevent adverse events or any drug-related problems.
• The possibility of revoking the authorisation for emergency use, at any time, if health risks are identified.
• Continuous monitoring of the results and advances of clinical research that are still in progress.

So, even if authorisation for emergency use is granted, a company sponsoring a clinical trial running in Brazil or abroad should continue to carry out studies and collect data in a controlled manner, and must make a request for sanitary registration with Anvisa. The application for authorisation for emergency use must include strategies that will be implemented by the applicant to ensure that ongoing clinical trials are able to assess the safety and long-term effectiveness of the drug.

The authorisation for emergency and temporary use of an experimental drug for COVID-19 is restricted to a predefined target audience and therefore does not replace sanitary registration in Brazil. The health record is the only appropriate instrument that will allow for the expansion of use of the drug in Brazil, in accordance with the guidelines for guaranteeing quality, efficacy and safety for these products. However, according to the Guide, emergency and temporary use provisions may bring benefits to certain groups, under controlled use, as an additional measure to combat the COVID-19 pandemic.

The Guide will be implemented immediately after its publication but will remain subject to comments in accordance with Anvisa’s regulatory practices.

“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”