APIs – global business
developments
Gian Mario Baccalini
EFCG Board Member, Chairman of EFCG Pharma Business Committee
President, B&P Development Srl, Italy
EFCG Press Conference, 9° October 2012, CPhI Madrid
New Legislation affecting APIs
Global Business Developments
Europe:
Falsified Medicines Directive (FMD), 2011/62/EU
1st July, 2011
USA:
Generic Drug User Fee Act (GDUFA)
1st October, 2012
The Falsified Medicines Directive (FMD)
2011/62/EU
• All EU countries are working on the transposition
into national rules of the FMD within 18/24 months
from its publication in the Official Journal (1st July,
2011)
• Some countries judge the Directive too strict and
others too lenient ( a health risk for EU citizens!)
Features of the European API
manufacturers
• Characterized by a high level of competence in fine chemistry:
– Chemical synthesis, fermentation, purification and separation
– Development in new technologies (enzymatic reactions, chiral
chemistry, green chemistry, continuous flow chemistry)
– Many reaction steps
– Flexible multi-purpose plants and top-level dedicated equipment
– High technology plants with reference to process and
engineering, and EHSQ systems
– Expertise in custom manufacturing activities with multi-national
pharmaceutical companies (NCE, APIs, advanced
intermediates), as a result of consolidated image of quality and
reliability.
Features of the European API
manufacturers
Employ a range of skilled, qualified & experienced staff for:
 Early assessment of market opportunities
 All technical (incl. ESHQ) management requirements
 Handling Intellectual Property Rights (e.g., patent issues)
 Production compliance with Good Manufacturing Practices
on the basis of inspections performed by Regulatory
Authorities
Where do the European
manufacturers stand?
 APIs market is more and more a worldwide business, integrated
in the supply chain
 Manufacturers of APIs give more value to their production
towards the dosage form
 Companies increase their size
 Manufacturers in new countries put more pressure on the
market, for instance: Turkey, Eastern Europe, Middle East
 Opportunities and challenges of selling APIs to BRICs countries
As we are in a global market, we need to establish a global
strategy
Some figures
APIs:
 Word market APIs: 32.0 billion US $
 European APIs production: 12.0 billion US $
 Italian market share APIs worldwide: 11%
Activities of European manufacturing:
 50% custom manufacturing
 50% generic medicines
Present legislative situation
 The current Directive covering human medicines does
NOT ensure that the APIs used in EU comply with
European GMP wherever they are made
 Mandatory inspections of EU API sites are performed by
EU Regulatory Authorities but there are no mandatory
inspections of non-EU API sites
 Over 70% of all APIs sold in EU now come from non-EU
sites
Future API legislative situation
 Evidence of illegal activities amongst APIs manufacturers in
non-EU countries, especially China and India
BUT...
 The FMD Directive, designed to stop illegal activities does
NOT require EU Regulatory Authorities to perform
mandatory inspections of non-EU APIs production sites for
compliance with EU standards
 Instead, it relies on the EU Market Authorisation Holder to
very this
 Imported preparations/medicines entering the EU
containing APIs from non-EU sources are to be even more
leniently regulated
EFCG Proposals
• EFCG proposes global harmonization of the rules
affecting the global market:
 Mandatory inspections
 Mutual Recognition Agreements (MRAs)
It is important that the on-going pilot inspection
programs between Regulatory Authorities result in
MRAs.
EFCG Position Paper
• EFCG latest position paper awaits Board approval
on 11° October, entitled:
“To
harmonize the rules in order to guarantee the
safety of pharmaceutical products and the citizen’s
health. Why are mandatory inspections needed?”
Its purpose is to inform all API stakeholders of EFCG’s
case for mandatory inspections via an MRA approach
performed by Regulatory Authorities.
FMD = EU Product Shortages?
 Asian API manufacturers supply ~70% of the EU market
since their low prices forced EU API manufacturers to stop
making lower cost APIs
 Some fear the FMD could result in product shortages until
Asian suppliers meet EU GMP manufacturing standards
 An alternative supply could be made available from EU
manufacturers, especially those who used to make these
APIs, provided the Regulatory Authorities fast-track the
necesssary approvals.
Conclusion
The implementation of mandatory inspections, via an MRA
approach, is a relatively small price to pay to guarantee the
quality of API meets the EU standard, irrespective of its
global source, for the benefit of the health of the EU
citizen and of the EU API manufacturing industry.
Thank you