WHO (World Health Organization), pre qualified their first bio-similar.
This newly pre qualified medicine is Samsung Bioepis’ Ontruzant which is a bio-similar version of trastuzumab.
After assessment WHO stated that
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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 forward to what’s installed in the start of the new
read more...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 the reliability of data and information in the production and
read more...Philippines’s FDA has been officially listed ASEAN MRA
Philippines’s FDA has been officially listed under the ASEAN Mutual Recognition Arrangement(MRA) on Good Manufacturing Practices(GMP) for medicinal products. This comes are the 28th ASEAN Consultative Committee On Standards And
read more...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 good manufacturing practice (GMP) inspections of sterile medicines manufacturing sites.
Specifically,
read more...USFDA issues draft guidance on bridging data for combination products
US FDA issued a draft guidance in regards to how drug-device and biologic-device combination product sponsors can bridge data from earlier stages or development or other development programs to support
read more...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...US FDA, Drug-device and biologic-device combination product sponsors bridging data draft
US, FDA issued a draft guidance in regards to how drug-device and biologic-device combination product sponsors can bridge data from earlier stages or development or other development programs to support
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
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