India has waived clinical trial requirements for new drugs with significant therapeutic advances that have been approved in the US, UK, Jap...

The Indian government is considering exempting medical devices approved in the European Union from clinical investigation requirements, sim...

The endorsement by the European Medicines Agency (EMA) allows EU member states to deploy the drug after the regulator gave guidance for its...

A rolling review is an accelerated way of assessing new drugs that allows European Medicine Agency experts to look at data from ongoing stu...

EU drug regulator said that it was assessing an application to extend the use of tocilizumab for adults suffering from severe coronavirus i...

The EMA website lists four vaccines as under rolling review — Sputnik V, Covovax, CureVac and Sinovac. An SII executive who is familiar wit...

In a statement Friday, the two pharmaceuticals said their request is based on an advanced study in more than 2,000 adolescents that showed ...

After initial hiccups with the US and EU drug regulators, Shaw said this approval signifies India and her company’s capability in developin...

Germany's drug regulator has suspended the marketing of 54 medicines clinically tested by India's GVK Biosciences in compliance.

Medicines affected by the sales ban will lose their validity for use in the EU and they should no longer be sold by pharmaceutical companie...

The German watchdog said it will take a decision shortly on whether to add more medicines to the list of banned drugs in the wake of the EM...

The European drug regulator has said that drugs from the Ranbaxy’s Toansa unit are fine. The regulator also said that the corrective measur...

"At present, there is no evidence that any of the products in the Australian market manufactured by Ranbaxy are of an unacceptable quality".

The UK drug regulator is reviewing Ranbaxy regulatory issues in the light of recent revelations to see whether the situation warrants any a...

DCGI is readying a plan to check if domestic bulk drug facilities that export to the European Union comply with WHO-prescribed norms.

India is preparing its case on the repeated seizures at European ports of its consignments containing off-patent drugs meant for other deve...

If the European Union does not allow Indian drugs to transit through its customs even after bilateral negotiations, India will drag Brussel...