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…
Are you aware that Decree of the Cabinet of Ministers of Azerbaijan RepublicNo. 503 on the Rules of Pharmacovigilance of…
Two new Pharmaceutical Inspection Co-Operation Scheme (PIC/S) guidance documents entered into force on 1 June 2020, a questions and answers…
On 19 May 2020 at a second workshop on observational studies co-organised by the EMA and Health Canada within the…
50 days left to the official start of the all-Russian labelling according to the new requirements of the Decree of…
National Center for Expertise of Medicines and Medical Devices of the Committee for Quality Control and Safety of Goods and…
The European Commission’s Medical Device Coordination Group posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for…
Amended Rules No. 736 “On the Rules of Evaluation of Medicines and Medical Devices” become effective on April 9, 2020.…
SmartPharma Group wishes this Easter would inspire you to new hope, happiness, prosperity and abundance!
The Department of Drug Supply of the Kyrgyz Republic suspends its work from 02.04.2020. Due to the spread of the…