The EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.

Granted IMC-G.A.P. Equivalency Certification by Control Union (“CU”)Milestone to export to Israel and EU-GMP facilities in ...

This article is authored by Ranjit Barshikar, CEO, QbD International, CGMP Consulting, United Nations Adviser.

The first official version of the European quality assurance scheme for breast cancer services is now available on the European Commission web hub. The scheme defines a set of quality requirements for ...

Serplulimab is the world's first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC Serplulimab is the first and only anti-PD-1 mAb approved in the European Union (EU) ...

Accomplished Leader to Oversee Quality and Compliance Across AIML's Global Operations▪ Strengthens AIML's Commitment to Providing Reliable and Innovative AI-Powered Healthcare Solutions VANCOUVER, BC ...

The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.

Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, ...

Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...

High-quality evidence for the treatment of very rare diseases: IQWiG is involved in the EU project RealiseD Developing clinical trials to provide good evidence for very rare diseases, so that ...

The HPRA is the national regulator across many different health products: medicines, particularly pharmaceuticals and ...