European Medicines Agency (EMA) launched a 2-year pilot that would allow regulators all across the world to share information on good manufacturing practice (GMP) inspections of sterile medicines manufacturing sites.
Specifically,
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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 for regulatory professionals.
With opportunities and challenges in technology making exponential
read more...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 devices.
This would replace earlier versions of the documents developed by
read more...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.
Medical devices with substances incorporated when used on their own could
read more...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 them are relating to Basic UDI-DI, which manufacturers can use to
read more...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 4 of the ICH process were adopted to promote innovation
read more...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 new feature combines 2 registration both import and product license in
read more...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 document ranges from a form of general questions to specific questions
read more...Eudamed upcoming plans
The European Commission database of Medical Device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been done.
They have decided to launch
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