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EUDRA GMDP DATABASE

GMDP Database showing Certificates, Licenses and Non-Compliance. EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators. General public access via Internet is available since 2009. Information can be found about: MIA – Manufacturing and import authorizations GMP – Good Manufacturing Practice (GMP) certificates. GMP – Statements of non-compliance with GMP EudraGMDP – D is the new part regarding DISTRIBUTION – is the new name for the Union database since 2013. In addition the following new information are available: WDA – Wholesale Distribution Authorizations GDP – Good Distribution Certificates GDP – Statements of non-compliance with GDP API – Registration of manufacturers, importers and distributors of active substances for human use located in the EEA All GMP and GDP certificatesare listed in a database by the European Medicine Agency and all GMP and GDP authorities in Europe should enter the GMP and GDP certificates via an interface into this EMA database. It’s not complete yet, but it’s growing: Nearly 700 GDP certificates have been recently added in the EudraGMDP, and also two GDP-non-compliance-reports have been published yet – on 19.02.2014 + 27.03.2014 , both by the Czech authority. There the important information wghile using that database may not be forgotten: The absence of a GDP/GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GDP/GMP. e.g.: Germany has not entered any data yet – not one single German WDA or GDP certificate can be found. Anyhow Medizone is full compliant to GDP (http://medizone.com/wp-content/uploads/2013/09/Medizone_GDP_Certificate_17062013_gc.pdf ) and of course holding a valid WDA (http://medizone.com/wp-content/uploads/2013/01/Medizone_Gro%C3%9Fhandelslizenz.pdf) The database can be accessed via http://eudragmdp.ema.europa.eu Also a list of the National Competent Authorities (NCA) of the EEA can be found: http://eudragmdp.ema.europa.eu/inspections/viewCompetentAuthorityAddresses.do

EC published QUESTIONS AND ANSWERS to the GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS FOR HUMAN USE

The EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and Medicinal products – quality, safety and efficacy Has published additional information to the GDP 2013/C 343/01 GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS

FOR HUMAN USE QUESTIONS AND ANSWERS VERSION 1.0 The documents sets out frequently-asked ‘questions and answers’ regarding the new guidelines on Good Distribution Practice of medicinal products for human applicable as of 8 September 2013, and their revision of November 2013. It can be found http://ec.europa.eu/health/files/gdp/2014-04_qas_.pdf

Medizone and PassionBio agree on closer cooperation

PassionBio’s provides drug development, regulatory and commercial solutions for biologics, biosimilar/-better or mAb programs. Our aim is to foster cross-frontier development of your biosimilar portfolio. We support you with (pre-)clinical trial design and with your interactions with EU regulatory authorities. We help you select the right CRO and negotiate competitive budgets with CROs and other contractors in Europe. For more information please refer to our corporate site on PassionBio LinkedIn or

visit www.passionbio.at

New EU GDP Guidelines – Part II

The “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” have been published 07.03.2013. But only a few months later the GDP had to be renewed. The new version 2013/C 343/01 “corrects factual mistakes identified in subchapters 5.5 and 6.3 of the revised guidelines. It also gives more explanations on the rationale for the revision as well as a date of coming into operation.” (1) Medizone happily acknowledged, that many of the additional translations errors were corrected by establishing the German translation of 2013/C 343/01. Unfortunately there again are some new translation mistakes in the German GDP of 05.11.2013, but less than before. This might be subject to another news coming up soon. Medizone is up2date and full compliant also to the newest version of the Guidelines. These are some more of the action items we performed and the results, we achieved:

  • 100% of transportation with qualified and audited logistics partners
  • Stringent rules on transport and temperature monitoring during transport work well, proven by self-inspection in February 2014.
  • Risk-Based self-inspection-plan has been implemented.
  • Risk-Based process on temperature control has been established and shows success while testing it in real life.
  • All SOP’s have been again reviewed to ensure full compliance to newest Version of the Guidelines of November 2013.
  • Description of the computerised systems of Medizone Germany GmbH as requested by GDP 2013/C 343/01 of 05.11.2013 has been finalized.

To be continued… (1) Introduction Section 3 With our procedures we try to get even better day by day to provide better service to our clients.

MabThera SC now approved in EU for patients with non-Hodgkin lymphoma

Roche announced today that the EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve MabThera (rituximab) 1400mg solution for subcutaneous (SC) injection for the treatment of patients with common forms of non-Hodgkin lymphoma (NHL). “We are excited the MabThera SC data confirm the efficacy and safety of a significantly shortened treatment time,“ said Sandra Horning, M.D., Chief Medical Officer and Head, Global Product Development. “We are confident that reducing treatment to approximately five minutes with MabThera SC will be an improvement for patients and healthcare professionals alike.” Currently, MabThera is delivered by an intravenous infusion which takes approximately 2.5 hours. The new MabThera SC formulation can be delivered over approximately five minutes and comes as a ready-to-use, fixed dose, which reduces pharmacy preparation time and overall impact on hospital resources. The CHMP opinion is based primarily on data from the phase III SABRINA study. Roche expects a final decision from the European Commission in the coming months. Source: Roche press release

Medizone supports “Wings for Life” Foundation

The driving forces behind Wings for Life are the two-time motocross world champion Heinz Kinigadner and the founder of Red Bull, Dietrich Mateschitz. In 2003, Kinigadner’s son Hannes had a tragic accident at the age of 19 which left him tetraplegic.

Moved by the dreadful injury, Kinigadner and Mateschitz invited leading scientists from across the world to come to Salzburg. It soon became clear that, contrary to common opinion, there is legitimate reason to hope that traumatic spinal cord injury can be cured. Ground-breaking discoveries made by Prof. Dr. Sam David in 1981 and by Prof. Dr. Martin Schwab in the early 1990s showed that injured nerve cells in the spinal cord are capable of regeneration after specific types of treatment.

Kinigadner and Mateschitz soon realised that research into spinal cord injury was underfunded. Paralysis is not considered a widespread condition and therefore investing millions in research to help a relatively small number of people was generally considered an unprofitable endeavour.

This realisation prompted Kinigadner and Mateschitz to set up the Wings for Life research foundation – with the goal of finding ways to cure all people affected.

100% of donations are used to fund basic research as well as preclicincal and clinical studies of promising new therapies and drugs. The administration costs are borne entirely by Red Bull.

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“My grandfather spent more than half of his life in a wheel chair after an accident. A friend of my son is paralyzed since years after a ski accident. It can happen to anyone of us. The question is not whether effective treatments and cures will be found, but when they will be found!
We are proud to support Wings for Life!”

Gerhard Hoerl
Managing Director – Medizone Germany

Biocon-Mylan’s Biosimilar of Herceptin approved in India

Biocon, India’s largest listed biotechnology company, informed it had received marketing authorisation from the Drugs Controller General of India (DCGI) for its trastuzumab biosimilar, being developed jointly with US’ Mylan, for the treatment of HER2+ metastatic breast cancer. The product will be launched during the last quarter of this financial year. This is the first approval for a biosimilar product developed by Biocon and Mylan, which joined the project in 2009. The product is a biosimilar to Swiss pharma giant Roche’s Herceptin, used for the treatment of this type of breast cancer. Biocon and Mylan will sell products under CANMAb and Hertraz brand, respectively. Biosimilars are independently developed follow-on versions of medicines after their patent has expired.

Apotex Canada received its first Biosimilar registration in Europe of Amgen’s blockbuster cancer treatment filgrastim!

Apotex’s version of filgrastim received regulatory approval from the European Commission. Out-of-patent filgrastim, a biologic drug branded as Neupogen by Amgen and as Grastofil by Apotex, is used to boost production of infection-fighting white blood cells in certain cancer patients receiving chemotherapy. The product will be marketed by Stada in nearly all European Union countries. Stada plans to start sales next year, hoping to win a slice of the 1 billion euro ($1.4 billion) European filgrastim market. Stada has been among the first European generics makers to invest in biosimilars, winning European approval for a version of aneamia treatment epo as early as 2007, but the business has so far failed to make meaningful contributions to group sales.

New EU GDP Guidelines of 07.03.2013 – Update 08.09.2013

The “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” have been published 07.03.2013 and will apply across the European Union as of 8 September 2013. With the project “GDP-Readiness” Medizone checked all SOP’s and procedures to ensure full compliance to the new Version of the Guidelines. These are only some of the action items we performed in the last six months:

  • All of our established and proven transport partners were re-qualified and Quality Agreements have been established, where they did not exist in the past.
  • The preparation for more stringent rules on transport and temperature monitoring during transport has been finalized and implemented.
  • The Cold-Chain-Procedures have been expanded to cover Controlled-Room-Temperature, too. SOP “Cold Chain” got “Thermo-Sensitive Pharmaceuticals”
  • All SOP’s have been reviewed to ensure full compliance to the new Version of the Guidelines.
  • CAPA-procedures – as we still did in the past – have been described in the new SOP “CAPA (Corrective And Preventive Action)”
  • Master Data Procedures – that we still handled according to the four-eye-principle in the past – have been described in the new SOP “Master Data”.

To be continued… With our procedures we try to get even better day by day to

provide better service to our clients.

Celltrion files for approval of trastuzumab (Herceptin) biosimilar (CT-P6) in Korea

On June 4th Celltrion officially announced that it has filed for Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration) approval of CT-P6 with same indications of the original product for breast cancer and metastatic gastric cancer. Upon receiving MFDS approval for CT-P6, Celltrion plans to launch its second mAb biosimilar product into the Korean pharmaceutical market. Celltrion previously filed for approval of their first biosimilar product Remsima in February 2012 and received approval in July of the same year. The original product of CT-P6, which is trastuzumab, has generated sales over USD 6.3 billion globally in 2012. CT-P6 is the first trastuzumab biosimilar to enter the regulatory approval procedure. Celltrion received approval for its first biosimilar product Remsima (biosimilar version of Remicade-infliximab) in July 2012 from the MFDS. In addition, currently, Remsima has been approved by various countries abroad and sales of Remsima have commenced in these foreign markets.

Source: Celltrion press release

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