Global Business Development 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)
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?
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.
Global Business Developments in APIs
•The new regulations on SCC will considerably impact on fine
chemical manufacturers since ECHA is walking away from
internationally agreed regulations and procedures to handle
chemical compounds. The new regulation puts European
manufacturers in a decisive disadvantage towards non European
•SCC may even force the shutdown of entire production lines
and plants in Europe. API manufacturers also often make
intermediates, it is a concern to the entire industry.
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
•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).
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.
Global Business Developments in APIs
•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!”
Thank you – Grazie – Merci
beaucoup – Dankeschoen – Gracias
Roger Laforce
GM F.I.S. Fabbrica Italiana Sintetici S.p.A.
Montecchio Maggiore/Italy
[email protected]
+39 0444 708 008
+39 348 902 9262

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