Mexico’s Patent Office, COFEPRIS Sign Agreement on Drug Patents
Officials with Mexico’s patent office and its pharmaceutical regulator have signed a new agreement aimed at preemptively clarifying patent protections for drugs in hopes of speeding the review process.
Health Canada Continues to Actively Monitor Supply of Medical Devices
Health Canada’s role in managing medical device shortages in Canada. It explains how the government continuously tracks and updates the list of devices in short supply, ensuring transparency and quick responses to potential shortages. By working closely with manufacturers, importers, and healthcare providers, Health Canada aims to stabilize the supply chain through regulatory adjustments and proactive policies.
The end of paper at Anvisa! Electronic Protocol is the future of Health Surveillance
The Brazilian Health Surveillance Agency (ANVISA) will fully adopt the electronic document protocol from March 13, 2025, as established by RDC 947/2024. This change will eliminate the need for paper documents, promoting greater agility in document analysis, modernizing processes and reducing operating costs, especially those related to digitization and physical storage.
Understanding Patent Process for Generics and Biosimilars in Japan
If you are planning to register a generic or biosimilar drug in Japan, it is essential to understand the country’s two-stage patent linkage system, that operates through Ministry of Health, Labor, and Welfare (MHLW) administrative notices rather than formal regulations. The First Stage ensures generic drugs do not infringe on brand patents during regulatory review.
RDC 954/2024 -Comprehending the Highlights and Impacts on Drug Registration
The National Health Surveillance Agency (ANVISA) has launched Collegiate Board Resolution, RDC 954/2024 introduces several updates to make the drug registration process more agile and in line with international standards. .
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.
Japan Updates Orphan Drug Designation System to Accelerate Treatments for Rare Diseases
Japan has recently implemented significant updates to its Orphan Drug Designation (ODD) system, aiming to foster the development of treatments for rare diseases. These changes, introduced in 2024, are designed to streamline the designation process, provide robust support to pharmaceutical companies, and expedite patient access to essential medications.
ANVISA’s New Rules for Post-Market Monitoring of Cosmetics: The Impact of RDC 894/2024
The National Health Surveillance Agency (ANVISA) has published two documents on the new rules for post-market monitoring of cosmetics. The Inspection Manual for Good Cosmetic Surveillance Practices and the Questions and Answers on RDC 894/2024 will support the implementation of the new regulatory guidelines and strengthen the safety of cosmetic products in Brazil.
Stakeholders Ask FDA to Harmonize Guidelines for Oligonucleotide-Based Therapies
The biopharmaceutical industry and other stakeholders are pressuring the US Food and Drug Administration (FDA) to harmonize its regulatory guidelines for oligonucleotide-based therapies. The request aims to eliminate discrepancies in the development, manufacturing and approval requirements for these innovative treatments, which have shown great potential in the fight against various genetic and infectious diseases.
ANVISA Publishes RDC 936/2024: New Guidelines for Health Products and Their Implications for Medicine
The National Health Surveillance Agency (ANVISA) has launched Collegiate Board Resolution (RDC) 936/2024, which establishes new guidelines for the regulation of health products. These changes aim to improve the safety and efficacy of products used in medicine, directly impacting health professionals and patients.
Health Canada Makes Clinical Information on Medical Devices Publicly Accessible
Health Canada Makes Clinical Information on Medical Devices Publicly in a significant move toward greater transparency in healthcare, Health Canada (HC), the country’s medical device regulator, has announced that clinical information submitted in support of medical device applications is now publicly available. This development marks a crucial step in empowering healthcare professionals, researchers, and the general public with access to critical data.