They have their own guidelines for the submission of MAA for marketingof pharmaceuticals and medical devices. They are trying to obtain the EU membership andtherefore it was worthwhile to compare the guidelines of these countries.Methods: The registration process of pharmaceuticals in Kosovo, Ukraine ...
Not only are existing regulations constantly reviewed and updated, the increasingly rapid rate of development in the pharmaceuticals field creates new issues that need to be addressed by new legislation. Written in plain language without confusing jargon or legalese, FDA Regulatory Affairs: A Guide ...
Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed guidelines which were adopted by the Food and Drug Administration (FDA) in the U.S.A., the European Medicines Agency (EMA) in the European Union and the Pharmaceuticals and Medical Devices Agency (PMDA) in ...
Different regulatory guidelines recommend establishing stability profile of pharmaceuticals at the time of drug development. The expiry date, retesting period and storage conditions of active drugs or products are established through stability analysis. Several regulatory guidelines exist for stability testing...
licensing (HSA)'s Pharmaceutical Affairs Practice) as of pharmaceuticals quality and identity of pharmaceutical products during by the COVID-19 Pharmaceutical Safety Pharmaceutical Affairs According to the requirements for "GUIDANCE Act had been approved regulatory GSP: mandatory all aspects of the ...
Track-4:Current GMP Guidelines (cGMP)& GxP in Pharmaceuticals CGMP refers to the Current Good Manufacturing Practiceregulationsenforced by the US FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations...
Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food supplements – all these products are subject to regulations designed by governments to protect public health. The Regulatory Affairs department ensures that their companies comply with all of the regulations and laws conce...
Further regulatory collaboration in ICMRA, coupled with CDER’s on-going standards efforts in other international regulatory harmonization and information-sharing bodies, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), can drive toward ...
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Level 1 Act Food, Drug, and Cosmetic Act Directive 90/385/EEC; 93/42E EC; 98/79 EC Drug Administration Law of the People’s Republic of China Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene, Therapy Products,...