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 carcinogen. In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in a number of blood pressure medicines known as ‘sartans’. This led to some product recalls and to a regulatory review, which set strict new…

Are you aware that Decree of the Cabinet of Ministers of Azerbaijan RepublicNo. 503 on the Rules of Pharmacovigilance of Medicinal Products comes into force in two weeks – n the 1st of July 2020. New Decree implements fundamental requirements that require MAH: operate Pharmacovigilance system compliant to the requirements of Good Pharmacovigilance Practice (GVP);…

Two new Pharmaceutical Inspection Co-Operation Scheme (PIC/S) guidance documents entered into force on 1 June 2020, a questions and answers guidance on implementing risk-based prevention of cross-contamination and an aide-memoire on health-based exposure limit (HBEL) assessments. In case of any questions or if you seek experienced support to achieve GMP compliance, please, contact us for…

On 19 May 2020 at a second workshop on observational studies co-organised by the EMA and Health Canada within the International Coalition of Medicines Regulatory Authorities, international regulators agreed to step up their cooperation in the following three areas: • Pregnancy research to examine the impact of both coronavirus disease and medication use on pregnant…

50 days left to the official start of the all-Russian labelling according to the new requirements of the Decree of the Government of the Russian Federation No. 1954 published on January 9, 2020 amending Resolution No. 1556. The worldwide situation associated with the threat of the spread of coronavirus has led to quarantine restrictions, which…

National Center for Expertise of Medicines and Medical Devices of the Committee for Quality Control and Safety of Goods and Services of the Ministry of Health of the Republic of Kazakhstan approved new standard contract templates:   for the translation services of the SmPC and PIL (package insert), layouts of the packaging to the state…

Amended Rules No. 736 “On the Rules of Evaluation of Medicines and Medical Devices” become effective on April 9, 2020. The National Center for Expertise of Medicines and Medical Devices of the Republic of Kazakhstan announced that all applications for marketing authorisation will be accepted in accordance with the amended Rules No. 736 from now…

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 coronavirus COVID-19, a state of emergency was declared in the country till 15th of April 2020 and a curfew was introduced in Bishkek.