Kestener & Vieira Advogados Report

Anvisa updates criteria for medicine pilot batch manufacturing

On 1 July 2022, the National Health Surveillance Agency (Anvisa) published Normative Instruction No 158/2022 (Portuguese language) regarding manufacturing of and post-approval changes to medicine pilot batches.

According to the Normative Instruction, a pilot batch is a batch of a pharmaceutical product manufactured through a representative and reproductive process of an industrial scale batch. It must comply, as far as possible, with the technical, operational, and manufacturing process of the proposed industrial batch, and ensure a high level of safety for the product to be reproduced on an industrial scale.

Through its new provisions, Normative Instruction No 158/2022 sets forth that:

• Industrial equipment can be used to manufacture medicine pilot batches. This can be done via a pilot plant containing equipment with reduced capacity and to the same operating principle as that used in the manufacture of the industrial batch.
• Pilot batches must be manufactured in accordance with Good Manufacturing Practices.
• It is no longer mandatory for pilot batch manufacturing to take place in the same place as the industrial scale manufacturing.
• If the register application or post-approval change is rejected by Anvisa, the products resulting from the pilot batches must be destroyed, with mandatory notification to the competent bodies.

The new instruction entered into force on 1 August 2022 and revokes Normative Instruction No 2/2009.

COVID-19: Anvisa updates criteria for continuous submission procedure for vaccine register application

On 28 July 2022, the National Health Surveillance Agency (Anvisa) published Normative Instruction No 164/2022 (Portuguese language) regarding the continuous technical data submission procedure for COVID-19 vaccine register applications.

The new Normative Instruction sets forth a differentiated register application procedure, which allows the analysis of COVID-19 vaccines data as it is generated and submitted to Anvisa, to allow a subsequent, formal submission of the register application once the regulatory requirements are filled.

According to Normative Instruction No 164/2022:

• Eligibility to apply for the continuous submission procedure requires (i) a Clinical Medicine Development Dossier to support evaluation of the steps inherent in developing an experimental medicine and (ii) the COVID-19 vaccine to be in phase III of clinical research.
• The technical documentation to be filed during the continuous submission procedure should comply with the format provided for in Guide No 24/2019. It can be sent in Portuguese, English and Spanish languages.
• Vaccines that have their analysis initiated by the continuous submission procedure may have their formal registration submitted after the assessment concludes. The applicant must also complete an evaluation of the sufficiency of data regarding the vaccine’s quality, efficacy and safety, to establish a benefit-risk balance.

The new resolution entered into force on 1 September 2022 and revokes Normative Instruction No 77/2020.

Anvisa updates criteria for radiopharmaceuticals

On 28 July 2022, the National Health Surveillance Agency (Anvisa) published Resolution No 738/2022 (Portuguese language) which provides for registration, application, notification, import and quality control of radiopharmaceuticals.

According to the Resolution, radiopharmaceuticals are medicines for diagnostic or therapeutic purposes, which, when ready for use, contain one or more radionuclides, non-radioactive components and radiopharmaceutical precursors, including components extracted from radionuclide generators.

Through its many provisions regarding the regulation of radiopharmaceuticals, Normative Instruction No 738/2022 sets forth the following criteria for a radiopharmaceutical subject to the notification procedure before Anvisa:

• There should not be a radiopharmaceutical with identical active pharmaceutical ingredient (API) registered with Anvisa.
• It must be marketed ready for use.
• It must be manufactured on prescription by a legally qualified health professional, for a specific patient.
• Its manufacturing should not exceed 100 prescriptions per radiopharmaceutical, per week.
• There must be no medicine registered with Anvisa, with diagnostic or equivalent therapeutic purposes, available on the market.
• It must be manufactured in Brazil, in a manufacturing unit duly authorised and licensed by Anvisa and the National Nuclear Energy Commission.
• Its manufacturing unit must comply with Good Manufacturing Practices.
• The radiopharmaceutical manufacturing unit must have its own quality control laboratory.

The new resolution entered into force on 1 September 2022 and revokes Resolution No 451/2020.

Reproduced from Practical Law with the permission of the publishers. For further information visit https://uk.practicallaw.thomsonreuters.com/