Advantages of Registering Biological and Health Products in Brazil
When it comes to health products in Brazil, understanding Anvisa’s regulatory requirements is essential. Two concepts often mentioned in this context are product registration and notification. Although both are necessary processes to guarantee the safety and efficacy of products available on the market, they have important differences in terms of criteria, requirements and procedures.
ANVISA Updates Rules for Clinical Research: Innovation and Agility in Drug Development.
In November, the National Health Surveillance Agency (ANVISA) announced important changes to its rules for conducting clinical research in Brazil. The new guidelines aim to reduce bureaucratic obstacles, speed up drug development and maintain the strict technical parameters needed to guarantee the safety and efficacy of products. Among the new features is the continuous data submission mechanism, an approach that promises to optimize the analysis and approval processes.
FDA Suggests Collecting data on Ovarian Toxicity in Cancer Drug Trials
The US Food and Drug Administration (FDA) is recommending that sponsors include the collection of data on ovarian toxicity in the development of cancer drugs.
FDA Proposes Removing Oral Phenylephrine as Active Ingredient in OTC Nasal Decongestants After Review
In November 2024 the Food and Drug Administration announced its proposal to remove phenylephrine from the approved list of over-the-counter drugs to treat nasal congestion, citing evidence that the oral version of the drug is ineffective.
Transfer certificate of GMP and Ownership of Products: What Companies Need to Know
The transfer of Good Manufacturing Practice Certificates (GMP) at Anvisa is a specific process, usually related to changes in certificate ownership due to corporate reorganization, such as mergers or acquisitions.
Industry Pushback on : Biosimilar, Biological medicines Industry, Food and Drug Administration, Generic Drug
The U.S. Food and Drug Administration (FDA) recently proposed issuing biosimilar product-specific guidance to streamline the approval process for biosimilars. While this move aims to make the pathway for biosimilar approvals more predictable and accessible, it has faced pushback from the pharmaceutical industry. Many industry leaders argue that this approach could inadvertently hinder innovation, increase regulatory burdens, and complicate the pathway to biosimilar market entry.