INFO KGV | LIFE SCIENCES DEZEMBER 2020

ANVISA JOINS PHARMACEUTICAL INSPECTION COOPERATION SCHEMES (PIC/S) 

On 30 November 2020, the National Health Surveillance Agency (ANVISA) published a press release (Portuguese language), announcing that it had formally joined the Pharmaceutical Inspection Cooperation Scheme (PIC/S), which recognises the Agency’s excellence in the surveillance of Good Manufacturing Practices (GMP) for drugs and pharmaceutical materials.

PIC/S promotes the adoption of rigid standards for its members by two main goals:

• International harmonisation, through reference guides on GMP and Good Practices on the Distribution of pharmaceutical products.
• Training with the goal of equalising inspection systems for GMP worldwide.

ANVISA has already been implementing and updating its regulations and procedures since its formal intention to join PIC/S in 2014. The conclusion of this process will bring benefits both to ANVISA and the Brazilian pharmaceutical industry, including the following (as highlighted by ANVISA):

• Drugs will be perceived as high-quality products and compliant with the best standards of surveillance worldwide.
• Reduction of double inspections by different authorities.
• Time and financial resource savings.
• Facilitation of exports to countries that accept the certification from PIC/S members.
• Greater market access.

 

CGSIM PUBLISHES RATE OF RISK FOR ECONOMIC ACTIVITIES SUBJECT TO HEALTH SURVEILLANCE

Beatriz M A Camargo Kestener, Rubens Granja, Natássia Misae Ueno, Bruno Fontes Muniz and Brenda Costacurta Ohnuki, Kestener Granja and Vieira Advogados

 

On 23 November 2020, the National Network Management Committee for Simplifying the Registration and Legalization of Companies and Businesses (CGSIM) published Resolution No 62/2020 (Portuguese language), concerning risk ratings for economic activities subject to health surveillance.

The Resolution aims to simplify, streamline and harmonise the proceedings and requirements within sanitary surveillance procedures and regulations set forth by local sanitary authorities. In this sense, the authorities shall consider the following risk ratings:

• Low risk, which does not require prior licensing and inspection.
• Medium risk, which requires inspection while the activities are already ongoing, supported until then by a provisional licence.
• High risk, which requires prior licensing and inspection.

 

The ratings consider a variety of factors concerning the nature of the activity and of the products and materials. If a single establishment performs more than one activity with multiple levels of risk, it will be subject to the higher level of risk requirements.

Thus, the Resolution provides two tables stating which activities shall be considered medium and high risk by local sanitary authorities. The authorities may also make their own regulations in response to local situations.

 

COVID-19: ANVISA PUBLISHES GUIDE ON EMERGENCY USE OF VACCINES

Beatriz M A Camargo Kestener, Rubens Granja, Natássia Misae Ueno, Bruno Fontes Muniz and Brenda Costacurta Ohnuki, Kestener Granja and Vieira Advogados

 

On 10 December 2020, the National Health Surveillance Agency (ANVISA) published Resolution No 444/2020 (Portuguese language) to make official the terms of the guide (Portuguese language) regarding the minimum requirements for authorising the emergency use of experimental COVID-19 vaccines, which was released on 2 December 2020.

 

The guide provides requirements for companies requesting to use their vaccines at an experimental level for specific patient targets. Among other requirements, the company must:

• Hold a federal operating licence (Autorização de Funcionamento de Empresa) for manufacturing or importing drugs.
• Have concluded clinical trial phases I and II for the product, with phase III ongoing in Brazil.
• Have presented a Dossier of Clinical Drug Development (Dossiê de Desenvolvimento Clínico de Medicamento).

Companies are also required to meet with ANVISA’s General Management on Biological Products to discuss the experimental vaccine. However, the decision ultimately lies with ANVISA’s Collegiate Board (Diretoria Colegiada da ANVISA).

Finally, companies must present data about the quality, safety and efficacy of their vaccine, as well as include a conclusive report about the risk-benefit aspect of the emergency use; and display their commitment to concluding the vaccine’s development as well as obtaining a marketing authorisation for the product.

 

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