The CDFA & the Chinese Pharmaceutical Industry

The CDFA & the Chinese Pharmaceutical Industry

China is currently recognized as the world’s second-largest pharmaceutical industry. However, the regulatory policies have been very challenging for many large foreign pharmaceutical enterprises, as well as innovative local companies. Some of the reasons for...

The Evolving Regulatory Environment in Japan (PMDA)

At DIA in June of this year, Tatsuya Kondo, Chief Executive of Pharmaceuticals and Medical Devices Agency (PMDA) gave a presentation on the future activities of the PMDA in Japan. In the presentation, Kondo discusses Japan’s “Rational Medicine”...

CFDA: The Face of Regulation in China

The China Food and Drug Administration (CFDA) was founded in 2013. Grown from the organization formally known as the State Food and Drug Administration (SFDA), the CFDA was created to combine multiple regulatory authorities into a singular regulation process for food...

Quality Medical Translation for Trials is Essential

Building upon last week’s post around the revision to MEDDEV 2.7/1, I wanted to take a quick look at contract research organizations (CROs) and their usage of translation services. Clinical trials are expensive and multi-faceted, as a consequence it is very common for...

What’s New in the MEDDEV 2.7/1

Last year the EU saw an update to the MEDDEV 2.7/1. This 4th updated version of the guideline not only increased in magnitude, but also brings forth more strict requirements for Clinical Evaluation Reports (CER) in Europe. What does this mean for translation? In some...