INFO KGV | LIFE SCIENCES AUGUST 2020

ANVISA LAUNCHES PUBLIC CONSULTATION ON SIMPLIFICATION OF DRUG REGISTRATION

 

On 29 July 2020, the Brazilian Health Surveillance Agency (ANVISA) published Public Consultation No 875/2020 (Portuguese language), which proposes to revise the rules on drug registration requests for general and biological products that are linked to the technical and clinical reports of a reference product that is already registered. The current rules are established by Resolution RDC No 31/2014 (Portuguese language).

The public consultation discusses a simplified procedure for submitting requests for registration, post-registration and registration renewal for general and biological medicinal products. Among other things, the proposed rules seek to establish the following:

• Drugs originating from technology transfers of Productive Development Partnerships will be registered using the ordinary procedure but in a simplified way as soon as the corresponding marketing authorisation is granted. This means that the drug will have more autonomy for registration and post-registration alterations.

• Exclusion of Article 24 of RDC No 31/2014, which establishes a 180-day period for the petition to change the registration of a product while maintaining the trade name. The proposed text introduces a staged procedure related to the petition for the cancellation of a current registration using the ordinary procedure and the request for new registration with the simplified procedure.

• Simplified registration requirements must be submitted with the updated operating licence of the requesting company of the simplified registration, along with a copy of the drug manufacturer’s good manufacturing practices certificate.

According to ANVISA, the revision of registration, post-registration and renewal procedures was considered essential for both ANVISA and the regulated sector due to difficulties in compliance with Resolution RDC No 31/2014.

The deadline for contributing to the consultation is 5 October 2020.

 

ANVISA PUBLISHES NEW PHARMACOVIGILANCE REGULATORY FRAMEWORK

Beatriz M A Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados

 

On 29 July 2020, the Brazilian Health Surveillance Agency (ANVISA) published two rules regarding the pharmacovigilance of drugs registered in Brazil:

• Resolution RDC No 406/2020 (Portuguese language), which establishes good pharmacovigilance practices for marketing authorisation holders (MAHs) of drugs.

• Normative Instruction IN No 63/2020 (Portuguese language), which establishes rules for the submission of the periodic risk-benefit assessment report before ANVISA by drug MAHs.

The new regulatory framework is now more extensive as it comprises the pharmacovigilance system, inspections, pharmacovigilance responsibilities of drug MAHs, routine actions of the pharmacovigilance plan and additional measures of the risk minimisation plan.

In addition, under the new normative instruction, periodic risk-benefit assessment reports shall be presented according to the date of international registration of the drug or combination of drugs and no longer based on the date of marketing authorisation approval in Brazil.

According to ANVISA, the new pharmacovigilance regulatory framework complies with the guidelines published by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and adopts internationally recognised practices for the post-marketing monitoring of drugs and the adverse drug events notification system.

Both new rules will enter into force 90 days from their publication date.

 

COVID-19: ANVISA PUBLISHES RESOLUTION EXEMPTING DRUG LABELLING AND LEAFLET REQUIREMENTS

Beatriz M A Camargo Kestener, Rubens Granja, Natássia Misae Ueno and Giovanna Pasquini Malfatti, Kestener Granja and Vieira Advogados

 

On 23 July 2020, the Brazilian Health Surveillance Agency (ANVISA) published Resolution RDC No 400/2020 (Portuguese language), which establishes extraordinary and temporary exemptions for specific drug labelling and leaflet requirements due to the COVID-19 pandemic.

In accordance with the discussions held between ANVISA and the regulated sector, the new resolution permits drug manufacturing companies to obtain a temporary exemption from the technical requirements relating to labelling and leaflets, provided that the exemption is necessary due to the COVID-19 pandemic, and the effects of non-compliance with the technical requirements are controlled.

In addition, the new resolution establishes a duty for companies requesting the exemption to include on their websites a description of the batches and presentation of the drugs subject to the exemption.

Resolution RDC No 400/2020 has already entered into force and will be automatically revoked when the Ministry of Health declares the COVID-19 public health emergency to be over.

 

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