Category: Standards

European Medicines Agency (EMA) has implemented a new system to issue electronic certificates for human and veterinary medicines. As of today, the Agency will no longer provide printed certificates...

In the dynamic and ever changing global regulatory outlook, the area of combination products is an exciting expanse of attainable innovation and discovery for both the drug and medical device industries....

Pharmaceutical companies are using various methodologies to ensure regulatory compliance with the health authorities. Still, there remains a loophole that prevents them from crossing the barriers set...

European Medicines Agency (EMA) explained considerations for implementing the International Council of Harmonisation’s (ICH) Q12 guideline on technical and regulatory considerations for pharmaceutical...

The US Food and Drug Administration (FDA) issued draft guidance providing recommendations on an alternate electronic format for submissions that qualify for an exemption or waiver from electronic common...

USA – Food and Drug Administration (FDA) The Center for Drug Evaluation and Research (CDER) continues its initiation to modernize the New Drugs Regulatory Program to better serve patients and to...