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Global Business Developments in APIs

Global Business Developments in APIs. 2011 – A BUSY YEAR ! The Falsified Medicines Directive GDUFA – Generic Drug User Fee Act REACH, Intermediates and Strictly Contained Conditions (SCC)

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Global Business Developments in APIs

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  1. Global Business Developments in APIs 2011 – A BUSY YEAR ! • The Falsified Medicines Directive • GDUFA – Generic Drug User Fee Act • REACH, Intermediates and Strictly Contained Conditions (SCC) • Global regulatory changes impacting APIs: SFDA, “near GMP” conditions for starting material manufacturers, Emerging Markets … as markets; • Trade barriers; • Where do European API manufacturers stand?

  2. Global Business Developments in APIs • The Falsified Medicines Directive FMD • approved on 16th February 2011 by the European Parliament, published on July 1st, 2011. • “Overall, we consider it to be a major step forward in the fight against falsified APIs and excipients in European medicines. However, as we do have some reservations about how it will work out exactly, we will be closely following the implementation by the Member States” says Dr Chris Oldenhof, APIC President and EFCG Board Member, as the two Sector Groups of CEFIC, APIC and EFCG have welcomed this approval. • The implementation of the Directive will take time and more efforts on European and national levels. EFCG and APIC will continue to follow this process which integrates itself in a number of international initiatives and efforts. • Important aspects of the FMD are: Import of APIs into the European market of APIs already included in medicinal products, cooperation on API inspections between EMA and EU member states, API inspection programmes, list of equivalent third countries, countries refusing to comply with FMD requirements, the EUDRA GMP Database.

  3. Global Business Developments in APIs • REACH , Intermediates and STRICTLY CONTAINED CONDITIONS (SCC) • The newregulations on SCC willconsiderably impact on fine chemicalmanufacturerssince ECHA iswalkingawayfrominternationallyagreedregulations and procedurestohandlechemicalcompounds. The newregulationputsEuropeanmanufacturers in a decisive disadvantagetowards non Europeanmanufacturers. • SCC mayevenforcethe shutdownofentire production lines and plants in Europe. API manufacturersalsooftenmakeintermediates, itis a concernto the entireindustry.

  4. Global Business Developments in APIs • Global regulatory changes that impact APIs • The Generic Drug User Fee Act to be voted in the US Congress in January 2012 would substantially benefit the compliant manufacturers worldwide and are the right and bold step towards a global level playing field for APIs. • Pharma supply chain management more and more asks for “near” GMP manufacturing conditions of non GMP starting materials and intermediates. • The Chinese FDA (SFDA) has announced that it will increase the level of compliance for Chinese manufacturers in the next two years; to be clarified what happens to Chinese manufacturers exporting and not working for the domestic market; • Some national regulations in Europe tend to overregulate thus creating competitive disadvantages for API manufacturers in such countries (Italy for example).

  5. Global Business Developments in APIs • Trade barriers • Some important countries still have higher trade barriers for non local suppliers with respect to local manufacturers (example: China). • EFCG is working on finding ways to raise the awareness of these conditions.

  6. Global Business Developments in APIs • WHERE DO EUROPEAN MANUFACTURERS STAND? • With the US market still the most important one for both originator (contract manufacturing) and generic APIs; • Multinational companies initiated a shift of focus towards emerging markets (BRICS: Brasil, Russia, India, China, South Africa); • European API manufacturers have reached highest levels of compliance from a regulatory and HSE standpoint; patients in emerging markets need the same quality standards like those in the so-called “developed countries”; • Overall, the market trends are positive, and most of our members see a positive development in their businesses. • “Chemistry in Europe is very much alive!”

  7. Thankyou– Grazie – Merci beaucoup – Dankeschoen – Gracias Roger Laforce GM F.I.S. Fabbrica Italiana Sintetici S.p.A. Montecchio Maggiore/Italy Roger.laforce@fisvi.com +39 0444 708 008 +39 348 902 9262

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