World Health Organisation Latest Guideline on Data Integrity

World Health Organization (WHO) drafted a new guideline on data integrity on 19th November 2019. This highlighted the importance of …

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Philippines FDA has been officially listed ASEAN MRA for GMP

Philippines FDA has been officially listed under the ASEAN Mutual Recognition Arrangement(MRA) on Good Manufacturing Practices(GMP) for medicinal products. This …

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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 …

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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 …

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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 …

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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. …

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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 …

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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 …

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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 …

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