New drugs or changes to medicinal products or their manufacturing process must be registered, after extensive research, before they are allowed to enter the market. In Europe these procedures are coordinated by the European Medicines Agency (EMEA); licenses are issued by the European Committee (EC) or national Competent Authorities.
These procedures are being coordinated by Johnson&Johnson Global Regulatory Affairs , Some departments of GRA, responsible for new products and new indications, as well as for safety related matters and the registration of new manufacturing processes are based in Leiden.
Global Regulatory Affairs Leiden
Regulatory Affairs in Leiden consists of the following sub-groups:
In the TA, the main focus of work is on new products and indications, on safety related matters, as well as on issues related to our Product Information, and resulting in changes to Printed Components. RSS includes several supporting functions: Regulatory Compliance (which covers adherence to legislations, SOPs etc.), Regulatory Operations (Electronic Document Management and Dossier preparation), Labeling Operations (coordination of preparation of packaging materials) and the CTA group (responsible for the approval process of clinical trials)
Global Chemistry Manufacturing & Control (CMC) is responsible for manufacturing information related to development products in clinical research (pre-approval) and as well as for changes to the manufacturing process for products which are already on the market (post-approval).
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