Profile of the pharmaceutical industry and relevant sector aspects

The Brazilian drug market has traded BRL 106,78 billion in 2022, equivalent to USD 20,70 billion [Pharmacy Channel), net value - average discount of 37,58%], according to surveys by IQVIA consultancy. There was an increase of 16,95% in BRL, compared to the previous year, representing approximately 2% of the world market, being the 10th in revenue in the ranking of the 20 main economies. In Latin America, it is the main market, ahead of Mexico, Colombia and Argentina.

An overview of the regulatory framework for advanced therapies / Regulatory Affairs Workgroup

English version of the document presenting the current global regulatory landscape for products falling under the category of advanced therapies, featuring high product complexity.

RWD (Real World Data) / RWE (Real World Evidence)

English version of the document aimed at presenting the main international references regarding the criteria and usage of RWD (Real World Data) and RWE (Real World Evidence) in regulatory decisions.

Sindusfarma Annual Activity Report 2022

The Sindusfarma Annual Activity Report 2022, in Portuguese, records the achievements of the organization in all of its areas of operation.

Advanced Therapies

“Advanced Therapies” magazine presents the main topics discussed by experts and authorities at the “Advanced Therapies Forum – Generating Value to the Patient and Health System Journey”, held by Sindusfarma in August/September 2021.

Gene and Advanced Therapies: Creating Value in the Patient Journey and the Health System

In the Gene and Advanced Therapies: Creating Value in the Patient Journey and in the Health System Forum, held by the Syndicate of the Pharmaceutical Industries (Sindusfarma) and the National Health Surveillance Agency (Anvisa) on October 23 and 24, 2019, in the agency’s auditorium in Brasilia, public managers, physicians, national and international researchers, congressmen, and healthcare leaders shared experiences in Brazil and in other countries. They discussed various aspects related to the theme, such as regulation, clinical research, diagnosis, legislation, financing, and sustainability of the system.

Guideline for the Advancement of Racial Equity in the Pharmaceutical Sector

Committed to reducing social inequality and overcoming institutional and structural racism in Brazil, Sindusfarma prepared a “Guideline for the Advancement of Racial Equity in the Pharmaceutical Sector”.

Written by Sindusfarma's Diversity Working Group, the document was approved by the entity's Board of Directors last December. Sindusfarma's GT Diversity has been operating since 2021.

Guide LGPD (Brazilian General Data Protection Act) - Pharmaceutical Industry

English version of the post about the Brazilian General Data Protection Act (LGPD), produced by the partnership between Sindusfarma and Interfarma. The content was developed based on the consultancy work of the law firm Chenut Oliveira Santiago Advogados, under the leadership of Fernando Santiago.

Clinical Research Week - Summary of Panels

Published in September/2020

English version of the consolidated and revised summary of the discussions from the four therapy panels of the Clinical Research Week, which took place between May 18th and 21st of this year, recorded for the International Day of Clinical Research.

Overview of ICH guidelines acceptance in Latin America

Published in November/2018

Gladys Silva, Juliana Rahal Cabello e Tatiana Gaban

Guidance: Good Practices in Medical Information

English version of the Good Practices in Medical Information

Rosana Mastellaro e Maiara Rigotto
Pharmaceutical Industry in Brazil - iconographic memory

Bilingual book (Portuguese-English) commemorating the 85th anniversary of Sindusfarma. The work outlines a broad panel of industries, facilities, equipment, work environments, medicines, advertisements and publications that illustrate the rich trajectory of the sector and its significant participation in the life of the country.

Impact Of Divergences In Pharmacovigilance Regulatory Requirements In Latin America Countries

Published in October/2019

Hernandez, Vivian; Pizani, Karen; Yoshikawa, Pedro S.; Carvalheiro, Tatiane; Abreu, Livia M.; Grunthal, Fernanda B; Coelho, Izabel; Pereira, Fernando; com o apoio do Sindicato da Indústria de Produtos Farmacêuticos (SINDUSFARMA)

Concept and rules comparison for: CPPs, origin country, reference country in Latin America

Published in November/2017

Cecilia Diaz, Juliana Perlow, Lilian Sabeh e Luciana Moraes

LGPD: Impact for pharmacovigilance processes

English version of the document that is intended for companies associated with Sindusfarma and whose purpose is to understand the impact of the Brazilian General Data Protection Act (LGPD) on the Pharmacovigilance Processes carried out by them.

Understanding and application of Circular Letter Nº 13/2020-CONEP/SECNS/MS

English version of "Understanding and application of Circular Letter Nº 13/2020-CONEP/SECNS/MS".The document aims to assist Clinical Research Centers and Sponsors in the stages of the process of preparing and submitting the requirements of Circular Letter Nº. 13/2020-CONEP/SECNS/MS to the Research Ethics Committees (CEPs).

Symposium New frontiers in manufacturing, technology, regulatory sciences and pharmaceutical quality system

The book 'Symposium New Pharmaceutical Frontiers - A Pioneer Project' documents the topics and speakers presented at the meetings from its inaugural edition in 2012 through 2017.

Sindicato da Indústria de Produtos Farmacêuticos

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