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EMA Notice: European Medicines Agency’s Data Protection Notice for the implementation of the Instrument for Pre-accession Assistance (IPA) programme
The European regulatory framework continues to strengthen data protection and transparency in its international collaborations, particularly when engaging with EU candidate countries. As part of this effort, the European Medicines Agency (EMA) has established clear guidelines on how personal data is processed within cooperation programmes. The guidance European Medicines Agency’s Data Protection Notice for the implementation of the Instrument for Pre-accession Assistance (I
Sharan Murugan
Apr 82 min read
Malaysia–China Medical Device Regulatory Reliance Programme: Pilot Phase I (30 July – 30 September 2025)
The Medical Device Authority (MDA) of Malaysia has officially launched the Malaysia–China Medical Device Regulatory Reliance Programme ,...
Sharan Murugan
Aug 13, 20252 min read
DRUGWATCH: Off-Label Drug Use: What You Need to Know
Off-label drug use refers to the use of a medication in a way that has not been approved by the Food and Drug Administration. This can...
Sharan Murugan
May 28, 20231 min read
USFDA's Notice: CMC Development & Readiness Pilot Program
Recently in a new program announced by the Food and Drug Administration (USFDA), a limited number of applicants will be able to...
Sharan Murugan
Nov 1, 20221 min read