World Health Organization first bio-similar pre-qualification
WHO (World Health Organization), pre qualified their first bio-similar. This newly pre qualified medicine is Samsung Bioepis’ Ontruzant which is …
2019 Round-up & What’s upcoming in 2020
As we close the year of 2019, let’s look at the most interesting stories of the past year and look …
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 …
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 …
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 …