Biologics & Biosimilar Regulations in European Union (EU) (EMA)
In Europe, biologics and biosimilars are evaluated through a lens of scientific comparability and public health responsibility. For executives, this […]
Biologics and Biosimilar Regulation and Registration in Japan (PMDA)
With the exception of the United States, Japan’s biosimilar business, with a market value of $140 million, accounted for just
Conformity Assessment of Medical Devices under EU MDR
EU MDR places clear responsibility on manufacturers to prove that their devices meet regulatory expectations. Conformity assessment is the mechanism
Regulations of Reusable Medical Devices under EU MDR
The introduction of the EU Medical Device Regulation (MDR) has brought increased emphasis on robust data and comprehensive evaluations for
Role of Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU
If you are responsible for placing a medicinal product on the EU market, you will come across the requirement to
Vietnam Medical Device Registration Process & Regulations
If you plan to sell medical devices in Vietnam, there’s a process you can’t skip. The government checks every product
EMA’s Clinical Trial Regulations (EUCTR) in European Union
The new EU Clinical Trial Regulation (CTR) 536/2014, which came into effect on January 31, 2022, represents a significant overhaul
Post-Market Surveillance In Medical Device Regulation
One of the biggest accomplishments in the journey of a drug product is its entry into the market as a
Medical Device Regulations and Registration In UK (MHRA)
Medical Device Regulations and Registration Process in the MHRA United Kingdom (UK) The publicly funded National Health Service (NHS) is