EMA launch of International Sterile Medicines Inspection Pilot Program
European Medicines Agency (EMA) launched a 2-year pilot that would allow regulators all across the world to share information on …
Transformation Of Digital Health for Regulatory Professionals
November 2019 saw a large focus on the changing digital health landscape alongside big data so what does this mean …
IMDRF released 3 documents on clinical evaluations, clinical investigations and clinical evidence for medical devices
International Medical Device Regulators Forum (IMDRF) released 3 final documents on clinical evaluations, clinical investigations and clinical evidence for medical …
Malaysia’s guideline for registration of combination products
Malaysia has fully implemented on 1st July 2019, the guidelines for registration of drug-medical device and medical device-drug combination products. …
European Commission released 8 documents for unique device identifiers (UDIs) for medical devices
The European Commission released 8 documents relating to technical specifications for unique device identifiers (UDIs) for medical devices. 4 of …
ICH guidelines Q12, E9(R1) and M9 adopted following assembly in Singapore
International Council for Harmonisation (ICH) updated on the Milestones achieved following their assembly in Singapore. A few guidelines for Step …
Vietnam, New Feature on Registration System VNSW
Vietnam Ministry Of Health has introduced a new feature on their registration website system VNSW on 29th October 2019. This …
European Commission released an aide memoire on practicing good distribution practice (GDP)
The European Commission released an aide memoire to assist pharmaceutical wholesalers in practicing good distribution practice (GDP). The 6 page …
Eudamed upcoming plans
The European Commission database of Medical Device information (Eudamed) will only be operational once all modules are fully functional and …