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Another Company recalls its products due to the presence of Nitrosamine impurities
Nitrosamine impurities, including N-Nitrosodimethylamine (NDMA), and N-Nitrosodiethylamine (NDEA), are probable human carcinogens, and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) is a potential human…
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Local Person responsible for Pharmacovigilance in Azerbaijan Republic
Are you aware that Decree of the Cabinet of Ministers of Azerbaijan RepublicNo. 503 on the Rules of Pharmacovigilance of…
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PIC/S adopts cross contamination
Two new Pharmaceutical Inspection Co-Operation Scheme (PIC/S) guidance documents entered into force on 1 June 2020, a questions and answers…
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Global regulators commit to cooperate on observational research in the context of COVID-19
On 19 May 2020 at a second workshop on observational studies co-organised by the EMA and Health Canada within the…
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50 days to the start of the drug movement monitoring (DMM) system in the Russian Federation
50 days left to the official start of the all-Russian labelling according to the new requirements of the Decree of…
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National Center for Expertise of Medicines and Medical Devices of the Ministry of Health of the Republic of Kazakhstan approved new standard contract templates
National Center for Expertise of Medicines and Medical Devices of the Committee for Quality Control and Safety of Goods and…
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Five new guidances posted by the European Commission’s Medical Device Coordination Group
The European Commission’s Medical Device Coordination Group posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for…
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Amended Rules No. 736 “On the Rules of Evaluation of Medicines and Medical Devices” become effective on April 9, 2020 in Republic of Kazakhstan
Amended Rules No. 736 “On the Rules of Evaluation of Medicines and Medical Devices” become effective on April 9, 2020.…
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Happy Easter holidays!
SmartPharma Group wishes this Easter would inspire you to new hope, happiness, prosperity and abundance!
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Suspension of work of the Department of Medicines Supply in Kyrgyz Republic due to COVID-19 pandemic
The Department of Drug Supply of the Kyrgyz Republic suspends its work from 02.04.2020. Due to the spread of the…
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