Strengthening Health in Latin America: Brazil and Mexico Join Forces in Historic Agreements
In a strategic move to strengthen public health in Latin America, Brazil and Mexico are advancing negotiations to sign important bilateral agreements. Preliminary discussions, which took place in August, involved a Brazilian delegation led by Vice President Geraldo Alckmin and the Mexican government, led by President Claudia Sheinbaum. The main focus of these agreements is cooperation in key areas such as vaccines, medicines, and regulatory harmonization. The final agreements are expected to be signed in 2026.
Anvisa’s Regulatory Agenda and Strategic Plan
This Blog analyzes the importance of ANVISA’s 2024-2025 Regulatory Agenda and its 2024-2027 Strategic Plan for companies operating in regulatory affairs. The text explains how these documents serve as a planning guide, helping companies anticipate new regulations and align their strategies to ensure compliance and operational efficiency.
PMDA Outlines Initiatives to Promote Pediatric Drug Development in Japan
PDMA’s report, published in Japanese in March and translated into English in April, outlines the need for action. The agency notes “growing concerns about the expansion of drug loss n Japan, where pharmaceuticals approved in the EU and the US are not being developed for Japanese patients.” The problem is particularly challenging for pediatric and orphan drugs, PMDA said.
Supporting the Development of Regenerative Medical Products for Rare Diseases
Japan, the Orphan Drug Designation (ODD) system is designed to promote the development of treatments for rare diseases, including regenerative medical products. Regenerative medical products, which encompass therapies aimed at repairing or replacing damaged tissues or organs, can qualify for ODD if they meet specific criteria.
Japan’s Orphan Drug Designation System: Advancing Medical Technologies for Rare Diseases
In Japan, the Orphan Drug Designation (ODD) system is a pivotal regulatory framework designed to encourage the development of medical devices targeting rare diseases. This initiative aims to address unmet medical needs by providing various incentives to manufacturers, ensuring that patients with rare conditions have access to essential medical technologies.
FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
The U.S. FDA issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation.
Anvisa approves release of vaccine and medicine against monkey pox
Anvisa approves release of vaccine and medicine against monkey pox
Registration of Generic & Comparative Drugs in Brazil
Before reaching the Brazilian consumer market, it is necessary that a drug has its quality, safety, and therapeutic efficacy evaluated by the National Health Surveillance Agency (ANVISA).
Brazil’s Fiocruz concludes genetic sequencing of monkeypox virus detected in Rio de Janeiro
Fiocruz, through its Genomics Network, has concluded the genetic sequencing of the monkeypox virus (MPXV) collected from a sample coming from Rio de Janeiro.
FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation
The U.S. FDA issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation.
THE US-FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain
FDA published FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain.
THE US-FDA publishes product-specific guidances (PSGs) to facilitate generic drug development
On May 2022, the FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, helping to streamline generic product