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.
Integration of the Health Surveillance Fee into the Single Foreign Trade Portal: Timetable and Impacts for Brazilian Trade
Anvisa (the National Health Surveillance Agency), in partnership with the Foreign Trade Secretariat (Secex) and the Federal Revenue Service, has announced the integration of the payment of the Health Surveillance Fee into the Single Foreign Trade Portal (Siscomex). This change is part of a move to centralize and digitize foreign trade processes, offering more agility, transparency and simplicity for importers and exporters dealing with products subject to health surveillance.
QCC x GMP: How does the Quality Control Certificate relate to ANVISA’s Good Manufacturing Practices?
The QCC (Quality Control Certificate) is indeed associated with ANVISA’s Good Manufacturing Practices (GMP), but they are not exactly the same thing. ANVISA’s GMP (Good Manufacturing Practices) is a regulatory requirement that certifies that health product companies, such as medicines and medical devices, follow safe and effective manufacturing practices. QCC certification is a type of quality control documentation that can be used to certify compliance with ANVISA’s GMP standards, but QCC itself is more of a type of control certification and does not replace the formal GMP authorization issued by ANVISA
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA. The Generic Drug User Fee Amendments (GDUFA) provides a framework for improving the efficiency and transparency of the review process for generic drug applications, known as Abbreviated New Drug Applications (ANDAs). One key aspect of this framework is the review of Drug Master Files (DMFs), which are critical for ANDA submissions involving drug substances, intermediates, or excipients that are not fully described in the ANDA itself.
ANVISA Intensifies Monitoring of Generic Drugs: New Requirements in Force
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.
Clinical Trials for Drugs/Medicines in Brazil and the Clinical Trial Application process
In Brazil, clinical trials for drugs follow strict regulations, guaranteeing the safety of participants and the efficacy of the drugs being tested. The regulatory body responsible is the National Health Surveillance Agency (ANVISA), which establishes rules for conducting these studies.