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EMA To Accept Non-EU…

EMA To Accept Non-EU Or Non-EEA Reference Medicinal Product RMP For Biosimilar MAAs.

European Biosimilars developers will be glad to hear that the reference product of  the Originators biologic, can be purchased outside the EU for comparative pivotal studies. The decision was made public by the EMA recently and the new policy should be implemented next year 2013 in the updated overarching „similar medicinal products“ guideline CHMP/437/04. With regard to the acceptance of US-sourced RMPs, a close collaboration with the FDA is foreseen to ensure harmonisation of requirements. This will be welcomed by US driven companies. Through our extensive network of approved supply partners we are be able to offer comparators from outside the EU at high quality and competitve prices.

New EU GDP Guidelines

We are all anxiously waiting for the final version of the new EU GDP Guidelines that are expected for release early 2013. We attended a seminar end of November in Munich to hear the latest news from the Head of our responsible inspection authorities. It looks like there will be several adaptions vs. the initial draft. We have already started to prepare ourselves for the more stringent rules on transport and temperature monitoring during transport by working on new SOP´s.

Shortages continue

The shortages for several oncological injectable products continue in Europe, US and several other countries. We do have close cooperation with several reputable Generic Manufacturers and deliver products with full documentation at reasonable prices. Last year we supplied bigger batches of Irinotecan, Paclitaxel, Docetaxel, Doxorubicin and Carboplatin to our customers and helped them to overcome product shortages or potential delays in clinical trials.

Extended Services in Russia

Medizone´s partner in Russia recently opened a state-of-the-art, GxP compliant depot for study medications and clinical trial material located near Moscow not far away from Domodedovo airport. Our partner has storage capabilities in all temperature conditions: ambient, chilled, frozen and LN2. The services cover all logistical aspects:

  • Local sourcing of comparator products and clinical trial material
  • Importation
  • Labeling / relabeling
  • Temperature controlled storage and distribution
  • Destruction
  • Exportation

We have performed successfully many local sourcing project for comparators. We can provide CoA´s and batch info prior to purchase.

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