Month: June 2020
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Medical Device Pharmacovigilance – Introduction
All regulated countries have distinctly defined medical devices, but Global Harmonization Task Force (GHTF) defined a medical device as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article, which is thereby intended to be used by the manufacturer for human beings for one or…
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Mandatory use of international standard for the reporting of side effects (ISO ICSR format) to improve safety of medicines
EMA’s Management Board agreed to the mandatory use of a consistent international format, the ISO ICSR format, for reporting individual cases of suspected side effects in patients across the world. The use of the new international standard will become mandatory as of 30 June 2022 for all reporting to EudraVigilance, the European database of suspected side effects with…
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New PV inspection follow-up procedures in the EU
The European Medicines Agency (EMA) have explained EU wide follow-up procedures for pharmacovigilance (PV) inspections in a 15-page guidance. According to Article 19 of Regulation (EC) No 726/2004 and Article 111 of Directive 2001/83/EC, the competent authority (CA) of a Member State (MS) where medicinal products are authorised, in cooperation with the EMA, shall ensure that the…
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Reporting suspected side effects of medicines in patients with COVID-19
EMA and the national competent authorities are reminding patients with confirmed or suspected coronavirus disease (COVID-19) to report suspected side effects that they experience with any of the medicines they are taking. This includes medicines to treat COVID-19, as well as medicines taken by patients to manage long-term, pre-existing conditions. It also includes medicines that…
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COVID-19 vaccine may be ready by October, pharma companies claims
Global pharmaceutical major Pfizer believes that a vaccine to prevent COVID-19 could be ready by the end of October, the company’s CEO Albert Bourla said. Pfizer is conducting clinical trials in the US and Europe for the BNT162 vaccine programme to prevent COVID-19 in collaboration with German mRNA company BioNTech, foreign media reported on Saturday.…
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Recall Alert for Metformin ER Products
On May 28, the FDA announced(www.fda.gov) that it had asked five pharmaceutical firms to voluntarily recall products containing extended-release formulations of metformin hydrochloride, a drug frequently prescribed to patients with type 2 diabetes to manage blood glucose levels. The recall stems from a recent series of tests that revealed unacceptably high levels of N-nitrosodimethylamine, a probable human…