What we stand for

ProGenerics > What we stand for

What we stand for

WHAT WE STAND FOR

OUR AREAS OF EXPERTISE

Access

Generic Medicines

Biosimilar Medicines

Regulatory Affairs

Intellectual Property

EXPAND
ACCESS

Broad, equitable and sustainable access to medicines is an essential pillar of public health and a central commitment of PróGenéricos. Ensuring that high-quality treatments reach as many patients as possible at competitive prices is what drives us.

Our job: to promote policies, regulatory reforms and initiatives that expand the supply of quality medicines in the Brazilian market, reduce economic barriers and strengthen supply predictability. We work to defend models that favor competition and encourage price reductions both in the private system and for SUS. We also seek to contribute with studies, data and proposals that support strategic decisions for the rational and efficient use of health resources, ensuring that the benefits of generics and biosimilars fully reach the population.

MEDICINES
GENERICS

Generic drugs represent one of the most important advances in the democratization of pharmaceutical treatment in Brazil. Since their regulation, they have made it possible to expand therapeutic options of proven quality, safety and efficacy, while stimulating competition and reducing costs for the health system and the consumer.

Our goal: to continually strengthen the regulatory framework for generics, ensuring predictability, legal certainty and a level playing field. PróGenéricos works to broaden society's understanding of the benefits of this category and works with public authorities to create policies that boost its production, registration and availability. In addition, we support initiatives that promote greater technological insertion, incremental innovation and the continuous improvement of the quality of generic drugs in the country.
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MEDICINES
BIOSIMILARS

PróGenéricos is deeply committed to discussions on biosimilars, addressing critical issues such as the interchangeability of these products with pioneering (or reference) biologics and the correct definition of prices, taking into account the investment and complexity involved. In addition, we collaborate in the evaluation and maintenance of patent terms for strategic biological medicines for the country, including those essential for the Unified Health System.

Our goal: to improve the regulatory and legal environment for biosimilars, allowing for the full development and broad access to this category of drugs, in order to repeat the success story of generic drugs in Brazil.


R REGULATORY ISSUES

Since the enactment of Law 9.787/1999, which regulates generic drugs in Brazil, PróGenéricos has been actively collaborating with the National Health Surveillance Agency (Anvisa) and government bodies. In this way, it contributes not only to the public consultations promoted by the Agency, but also with suggestions for improving and strengthening health policies that affect the pharmaceutical sector.

Our mission: to represent our members and, together, identify and overcome the regulatory challenges affecting the segment, ensuring greater efficiency and safety in the registration and marketing processes for generic and biosimilar drugs, and promoting a regulatory environment that is favorable to development and innovation in the pharmaceutical market.
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INTELLECTUAL PROPERTY
INTELLECTUAL PROPERTY

It plays an important role in preserving pharmaceutical patents and holds the right to exploit them for 20 years.

Our role: to monitor and report to government agencies cases of undue extension of terms, also taking legal action to combat these practices. To help members generate innovations without infringing third-party patents and to promote the strategic use of patent information.

WANT TO KNOW MORE
ABOUT ABOUT US

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The organization's Code of Ethics and Conduct

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THE ORGANIZATION'S BYLAWS

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OUR
PARTNERSHIPS

PróGenéricos maintains strategic partnerships with the Medicines Reverse Logistics System (LogMed) and the International Generic and Biosimilar Medicines Association (IGBA).

These collaborations provide direct benefits to members, strengthening alignment with national and international best practices on issues such as environmental sustainability, regulatory compliance and access to global trends in the pharmaceutical sector.

logmed

LogMed:
Reverse Logistics System (
)

PróGenéricos is one of the sponsoring organizations of the reverse logistics system operated by LogMeda management entity that acts as an integral part of the National Solid Waste Policy.

A LogMed is responsible for the complete execution of reverse logisticsand all the steps required by law:

- Collection of medicines discarded by the population;
- Transportation and environmentally appropriate final disposal;
- Registration, control and documentation of all stages;
- Detailed reports sent to the competent authorities.

 PróGenéricos members can count on easy access to LogMed's reverse logistics systemwith all the legal requirements already met, becoming an industry adhering to the program.


's main benefits include:

- Direct compliance with the requirements of Decree No. 10.388/2020;
- Reduction of legal and environmental risks;
- Cost optimization with collective solutions;
- Transparent and simplified accountability to the Ministry of the Environment.

 If your company doesn't yet have a structured solution for reverse logistics of medicinesThe association with PróGenéricos may be the most agile and efficient way of seeking out regulatory compliance and environmental responsibility.

LogMed: Reverse Logistics System

PróGenéricos is one of the sponsoring organizations of the reverse logistics system operated by LogMeda management entity that acts as an integral part of the National Solid Waste Policy.

A LogMed is responsible for the complete execution of reverse logisticsand all the steps required by law:

- Collection of medicines discarded by the population;
- Transportation and environmentally appropriate final disposal;
- Registration, control and documentation of all stages;
- Detailed reports sent to the competent authorities.

 PróGenéricos members can count on easy access to LogMed's reverse logistics systemwith all the legal requirements already met, becoming an industry adhering to the program.

Key benefits include:

- Direct compliance with the requirements of Decree No. 10.388/2020;
- Reduction of legal and environmental risks;
- Cost optimization with collective solutions;
- Transparent and simplified accountability to the Ministry of the Environment.

 If your company doesn't yet have a structured solution for reverse logistics of medicinesThe association with PróGenéricos may be the most agile and efficient way of seeking out regulatory compliance and environmental responsibility.

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International Generic and Biosimilar Association (IGBA)

A IGBA is the entity that represents the global medicines industry generics and biosimilars, promoting access to quality, safe, effective and cost-effective treatments around the world.

The IGBA is made up of pharmaceutical industry associations and the PróGenéricos is Brazil's representative in this international network.

Advantages for PróGenéricos Members

Thanks to its proximity to IGBA, PróGenéricos offers its members direct and strategic access to information of international relevance, how:

- Global regulatory and market trends;
- Legislative changes in other countries with an impact on the sector;
- Good practices and technical discussions adopted by other health authorities and regulatory agencies.

This partnership guarantees PróGenéricos members a strategic vision on the direction of the sector, strengthening its competitiveness and adaptability on the national and international market.


International Generic Medicines Association (IGBA)

and Biosimilars (IGBA)

A IGBA is the entity that represents the global medicines industry generics and biosimilars, promoting access to quality, safe, effective and cost-effective treatments around the world.

The IGBA is made up of pharmaceutical industry associations and the PróGenéricos is Brazil's representative in this international network.


Benefits for ProGenerics members of the ProGenerics Association (
)

Thanks to its proximity to IGBA, PróGenéricos offers its members direct and strategic access to information of international relevance, how:

- Global regulatory and market trends;
- Legislative changes in other countries with an impact on the sector;
- Good practices and technical discussions adopted by other health authorities and regulatory agencies.

This partnership guarantees PróGenéricos members a strategic vision on the direction of the sector, strengthening its competitiveness and adaptability on the national and international market.