GMP: EU GMP Non-Compliance Report might lead to FDA Import Stop in future

The new MRA Agreement between the EU and the USA on the mutual recognition of GMP inspections is being discussed in depth. One shouldn't conclude though that the inspection pressure would ...

RAPS: Generic Drugs From Four Indian and Chinese Companies Blocked From Entering US

The US Food and Drug Administration (FDA) on Wednesday added four Chinese and Indian companies to a list of generic drug facilities that are banned from shipping products to the US because they ...

GMP: New MHRA Q & A Document on the Import of Active Pharmaceutical Ingredients

In article 46 b of Directive 2011/62/EU it lays down strict rules for the import of active ingredients in the EU. Each import from countries outside of the EU must be accompanied by a written ...

GMP: EU Commission publishes Version 2.0 of the Question and Answer Document on API Importation

The European Commission has published a Version 2.0 of the Q&A document \"Importation of Active Substances for Medicinal Products for human use\" on 26 October. Version 1.0 was published on 10 ...

GMP: New Rules for the Importation of APIs - a European Commission Leaflet provides Information

The rules for importing active substances for medicinal products for human use from third countries into the EU have been reformed. The European Commission has already published a document setting ...