ALL ABOUT PHARMACOVIGILANCE

The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of individual Case Safety Reports” reached reached Step 2 of the ICH process on 5 February 2024. The ICH E2D guideline provides guidance on definitions and standards for post-approval individual case safety reporting, as well as good case management…

Reference: https://www.fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication

EVWEB  user manual is part of the official documentation prepared by the European Medicines Agency (EMA) to support the use of the EudraVigilance Web reporting tool (EVWEB). The Manual has been updated to version 1.7 (29 February 2024). Revision 1.7 contains the following updates: Reference: Click to access eudravigilance-evweb-user-manual_en.pdf

The sponsor of a medical device that is: Then the sponsor should submit three consecutive annual reports to TGA after the device is included in the ARTG as a post marketing obligation. The submission of annual reports is part of the device lifecycle approach for the sponsor to demonstrate that: Due dates and reporting periods:…

COFEPRIS, the Mexico regulatory authority, has mandated to transmit WHODrug Medicinal Product ID (MPID) and WHODrug Version in the E2B R3 report from 1 Jan 2024. This is to be used in pre-marketed and post-marketed cases – all drugs/vaccines (Suspect / Concomitant / Interacting / Historical Drugs). Click to access Planteamiento_para_WHODrug_1.1_21-03-2023_version_ingles.pdf Click to access Anexo_2._How_to_use_the_WHODrug_C3_format_for_drug_coding.pdf…

The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific informationon unapproved uses of approved/cleared medical devices and pharmaceuticals. The draft guidance replaces the 2014 document, “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices,” and presents revised recommendations in…

Medicines containing topiramate are registered for the treatment of epilepsy and for the prevention of migraine. Topiramate is known to cause birth defects in the baby if used during pregnancy. The European Medicines Agency’s (EMA) Risk Assessment Committee (PRAC) reviewed all available information, including the recently published results of three observational studies. Two of these…

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic products many consumers use daily. On September 15, 2023, FDA announced its…

Thailand is preparing to open its first renewal period for drug marketing authorizations (MAs) since the passage of the Drug Act (No. 6) B.E. 2562 (2019). Before 2019, MAs for pharmaceuticals and vaccines in Thailand had lifelong validity. The 2019 Drug Act stipulated that all new MAs would be valid for seven years and could…

In recent weeks, the Chief Sanitary Inspectorate (Główny Inspektorat Sanitarny, GIS) has been taking  an increasing interest in the safety of cosmetics.  In August 2023, two announcements were published on the GIS website regarding restrictions on the  composition and use of such products. In a communication dated 4 August 2023, GIS stressed that cosmetics are not…