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International Drug Regulatory Affairs

The International Drug Regulatory Affairs (IDRA) Group is responsible for planning, coordinating and performing all processes associated with the licensing of Octapharma’s biopharmaceutical products in different countries. The obtained registration certificates are the legal prerequisites for marketing of products in specific countries. The work includes:

 

  • Communicating with national health authorities worldwide within highly regulated procedures for medicinal product licensing

 

IDRA works with national authorities in Europe, the USA, Canada, South America, Africa, Russia, the Middle East, Asia, China, Australia, and New Zealand, as well as the European Medicines Agency (EMA) in London.

 

IDRA’s experience covers many types of submissions: Centralised Plasma Master File (PMF) in the EU, Mutual Recognition Procedures and Decentralised Procedures in the EU, Scientific Advice at EMA, Orphan Drug applications in Europe and the USA, IND and BLA in the USA, and worldwide national registration procedures. IDRA continuously follows up new regulatory guidelines and their implication for the regulatory work at Octapharma.

 

IDRA is the first contact point when national authorities address questions to Octapharma during the registration procedures and later on during procedures related to the product lifecycle. IDRA forwards these questions to the relevant experts within the company in order to compile adequate responses in continuous teamwork within the requested timeframe.

 

  • Communicating with all groups and units at Octapharma that provide documents for regulatory submissions

 

This includes Pre-Clinical R&D, Clinical R&D, production departments at all sites, Quality Assurance, Quality Control, International Business Units, Drug Safety, and the legal department.

 

Octapharma’s structure enables direct, fast, straightforward and flexible interaction with all authors contributing documents for regulatory submissions. Formatted templates have been established by IDRA in close collaboration with other departments so that authors compile documents that are fully compliant with the electronic Technical Document (eCTD) standard for electronic submissions.

 

  • Writing documents for the regulatory dossier

 

IDRA compiles electronic and paper submissions with specific software. Dossiers are compiled centrally either at the Regulatory department in Vienna or in Langenfeld, Germany. Dossiers are then submitted either directly to the national health authorities or via local affiliates or external consultants.

 

  • Maintaining Octapharma’s internal Regulatory Database

 

This contains the detailed regulatory status and product information for each submitted product for all countries. Specific product-related queries enable all Octapharma employees to retrieve information from the database.