ALL ABOUT PHARMACOVIGILANCE
-
EMA updated guidelines on Publication of RMPs and their summaries
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…
-
New Medical device- Post market surveillance Requirements – Great Britain – 2023
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…
-
Software as a medical device – TGA excluded products
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…
-
FDA – Class I recall of Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs)
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…
-
PharmacoVigilance Monitoring System (PViMS)
PViMS, or the PharmacoVigilance Monitoring System, is a web-based application used by clinicians, regulatory bodies, and implementing partners to monitor the safety of medicine to monitor the safety of medicines. The application was developed by the US Agency for International Development-funded Systems for Improved Access to Pharmaceuticals and Services [SIAPS] program (2011-2018) and is implemented…
-
Pfizer warns against counterfeit Dostinex
The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the public of a circulation of counterfeit Dostinex (Cabergolin) 0.5mg tablet in Nigeria. The Agency is issuing this alert following the notification received from Pfizer Specialties Limited (The manufacturer of the original product) disclosing a patient’s complaint about the product. Pfizer has…
-
Recall alert after 159 infant deaths in Indonesia from NAFDAC – Indonasian health authority
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying Healthcare providers and the public that Indonesian authorities have revoked the licenses of two pharmaceutical companies (PT Yarindo Farmatama and PT Universal Pharmaceutical industries) to prevent them from producing syrup-type medicines following the death of 159 children under five (5) years, due…
-
Brazilian ANVISA authorizes exceptional drug and vaccine use against Monkeypox by the Ministry of Health
The Ministry of Health (MH) sent Brazilian National Health Surveillance Agency (Anvisa) a request for exemption from the sanitary registration, on an exceptional and temporary basis, of the drug Tecovirimat concentration 200 mg, capsule, oral use, for the treatment of Monkeypox, due to the public health emergency of international importance. The drug will be acquired…
-
FDA class 1 recall of medical device: the most serious type of recall
Medtronic is recalling Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Resynchronization Therapy Defibrillators (CRT-Ds) after receiving reports of devices with a short circuit protection (SCP) alert resulting in reduced-energy electric shock delivery, instead of delivering a second phase of high voltage therapy. A reduced-energy electrical shock may fail to correct an irregular heartbeat (arrythmia) or may…
-
Decommission of eSUSAR by MHRA
The MHRA is retiring the eSUSAR website in favour for Individual Case Safety Reports (ICSR) Submissions, providing users “a more robust, stringent, and transparent way of expediting suspected unexpected serious adverse drug reactions (SUSARs) from Clinical Trials of Investigational Medicinal Products” (IMPs). The eSUSAR website used for the submission of SUSAR reports to the MHRA…
Got any book recommendations?