ANVISA Intensifies Monitoring of Generic Drugs: New Requirements in Force

Overview

The National Health Surveillance Agency (Anvisa) recently announced a new package of regulatory measures aimed at strengthening the monitoring of generic drugs in Brazil. The aim is to ensure even greater safety and efficacy for these products, which are widely used by the population and represent a significant part of the national pharmaceutical market.

Introduction

Anvisa’s decision follows the trend of international regulators who, in recent years, have been increasing requirements for generic drugs, especially in terms of pharmacovigilance. Pharmaceutical companies will have to adjust their post-market monitoring processes and be ready to provide more detailed safety reports in shorter timeframes. In addition, the new rules could have a financial impact on laboratories, especially smaller ones, which will have to invest more in clinical studies and restructuring their monitoring systems. However, experts point out that the measures are positive in the long term, as they guarantee greater confidence among consumers and health professionals in the use of generic medicines.

The new guidelines include:

Periodic Safety Reports (PSRs): Anvisa has intensified the obligation to submit PSRs for generic drugs, with the aim of continuously monitoring adverse effects and possible therapeutic failures. Companies will have to submit reports every 12 months, and any serious adverse events must be notified within 7 days.

Bioequivalence tests: The rules for bioequivalence studies, which ensure that the generic drug has the same efficacy and safety as the reference product, have also been strengthened. From now on, laboratories will have to carry out more comprehensive tests, covering a greater number of age groups and patient profiles, to ensure that the drug is effective for different population groups.

Labeling and Packaging: New requirements have been established to improve the legibility and clarity of information on generic drug packaging. Anvisa has determined that the packaging should contain clearer information on dosage and possible drug interactions, with the aim of reducing medication errors.

Deadlines and compliance

The new requirements will come into force in January 2025, but Anvisa is providing a six-month adaptation period for companies to adapt to the new rules. During this period, the agency will hold workshops and technical meetings to clarify the sector’s doubts and help companies with the regulatory transition.

Anvisa stresses that the new regulations seek to improve the pharmacovigilance system in Brazil, ensuring that generic medicines remain a safe, effective and affordable option for the population.

Conclusion

If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.

GRP can act as your local Agent & Register your product in U.S

Contact our team today to Inquire!

 Email: info@globalregulatorypartners.com

Telephone : (+1) 781-672-4200

References

Learn more about Anvisa. For the link, click here

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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