Year: 2023

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The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific informationon unapproved uses of approved/cleared medical devices and pharmaceuticals. The draft guidance replaces the 2014 document, “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices,” and presents revised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

From 20 October 2023, EMA is publishing RMPs (main body and annexes 4 and 6) for all centrally authorised products: initial evaluations;RMP updates. EMA no longer publishes RMP summaries from the same date. The aim is to increase transparency of the safety review process for all centrally authorised products. The RMP or RMP summary is…

The government has published The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 to amend the current regulations on post-market surveillance of medical devices placed on the market in Great Britain (“PMS Regulations“). The draft statutory instrument was notified to the World Trade Organization and made available on their website on 26 July 2023. The…

 The Therapeutic Goods Act 1989 sets out the criteria for the inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (ARTG), the process for securing authorisation from the Therapeutic Goods Administration (TGA), and requirements for advertising, labelling and product appearance.  Medical devices that incorporate or are comprised of software (including software as a…

Datascope/Maquet/Getinge is recalling the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) because they may shutdown unexpectedly due to electrical failures in the Power Management Board or Solenoid Board (Power Source Path). Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (for example: inadequate blood supply or a vital…