Overview
This blog post dives into the indispensable role of Regulatory Affairs in bringing health products and medicines safely to market and ensuring their ongoing compliance. It explores the critical processes of product registration and post-market surveillance (pharmacovigilance/technovigilance), highlighting why mandatory reporting of serious and unexpected adverse events is crucial, even when initial causality assessments are “not related.” Ultimately, the article emphasizes how expert regulatory teams, like GRP Brazil, are essential partners in navigating complex regulations to ensure patient safety and business success.
Introduction
In the complex health ecosystem, the journey of a product—be it a groundbreaking new medicine or an innovative medical device—to the patient is paved with rigorous regulatory requirements. Far from being a mere formality, Regulatory Affairs is the bridge that connects science and innovation to the safety and compliance demanded by health agencies, such as ANVISA in Brazil. In this blog, we will clarify this journey and highlight why having a specialized team is not just an advantage, but a strategic necessity.
Regulatory Affairs
Regulatory affairs is a continuous cycle, beginning long before a product launch and extending throughout its entire lifecycle. The two pillars of this process are Product Registration and Post-Market Surveillance.
1. Product Registration: The Starting Point
Registration is the passport that allows a product to enter the market. The process is detailed and meticulous, requiring the compilation of a comprehensive dossier that attests to the product’s safety, efficacy, and quality. This dossier, which must be submitted to ANVISA, includes:
· Evidence of Safety and Efficacy: Clinical and non-clinical studies that prove the product performs as expected and is safe for use.
· Manufacturing Information: Details on production, quality control, and composition, ensuring the product is safe and consistent.
· Labeling and Instructions for Use: Approved to ensure all information provided to healthcare professionals and patients is clear and accurate.
An experienced regulatory affairs team is essential to ensure this process is conducted efficiently, avoiding delays and securing approval.
2. Pharmacovigilance and Technovigilance: The Commitment to Ongoing Safety
After approval and launch, the responsibility continues with surveillance. Pharmacovigilance monitors medicines, and Technovigilance monitors health products. The goal is to identify and manage adverse events or technical complaints that may arise from widespread product use.
A recent case serves as a prime example: the notification of a serious adverse event, such as a seizure, associated with a botulinum toxin. Even though the original manufacturer (Croma-Pharma GmbH) and the partner assessed the causality as “not related” due to the latency period and the product’s local mechanism of action, notification to ANVISA (through the VigiMed system) is mandatory. The reason is simple: the event was classified as serious (it resulted in hospitalization) and unexpected (the seizure was not listed in the package insert). The Marketing Authorization Holder (MAH) in Brazil (GRP Brazil) must report the case so that ANVISA can have full knowledge and, if necessary, monitor the product’s safety at a national level.
Key Points
· Registration is a complex process that demands expertise to avoid delays and ensure approval.
· Post-market surveillance is a pillar of patient safety and a legal obligation.
· The notification of serious and unexpected adverse events to ANVISA is mandatory, even if causality is not confirmed.
· The MAH in Brazil is legally responsible for all regulatory aspects of the product in the country, including surveillance.
· A qualified regulatory affairs team ensures the company stays updated with constant changes in regulations and guidelines.
Conclusion
The journey of a health product to the market is one of high responsibility. More than just meeting a list of requirements, the field of regulatory affairs is a continuous commitment to patient safety and trust.
In this challenging environment, GRP Brazil stands out by having a team ready to assist you, with deep knowledge of ANVISA’s regulations and the agility needed to ensure your products reach the market safely and efficiently. Our mission is to be your strategic partner, transforming the complex regulatory landscape into a clear and secure path for your business’s success.
GRP Brazil
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.