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
Regulatory News
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
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
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 comes after the 28th ASEAN Consultative Committee On Standards And
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 good manufacturing practice (GMP) inspections of sterile medicines manufacturing sites.
Specifically,
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
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
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
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