APIs – global business developments. Gian Mario Baccalini EFCG Board Member, Chairman of EFCG Pharma Business Committee President & CEO, Euticals S.p.A., Italy EFCG Press Conference, 22° October 2013, CPhI Frankfurt. Features of the European API manufacturers.
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Gian Mario Baccalini
EFCG Board Member, Chairman of EFCG Pharma Business Committee
President & CEO, Euticals S.p.A., Italy
EFCG Press Conference, 22° October 2013, CPhI Frankfurt
As we are in a global market, we need to establish a global strategy
Activities of European manufacturing:
Falsified Medicines Directive (FMD),2011/62/EU
Came in to force on 2nd July, 2013
Generic Drug User Fee Act (GDUFA)
Came into force on 1st October, 2012
flexibility exists as it is a Directive not a Regulation (like REACH)
Top benefits rated by API producers
EFCG, APIC & SOCMA filed a proposal with both the EU and US government negotiators on MRAs for GMP Inspections
EFCG, APIC & SOCMA presented their case in Washington DC along with all other pharma trade bodies
Outcome: Agreement that all EU & US pharma trade bodies wanted the same thing – MRAs for GMP Inspections
EU Pharma trade bodies briefed DG Trade on their needs from TTIP ahead of 1st round of negotations in Washinton DC
2nd round of negotiations cancelled due to US Shut Down.
Letter to DG Sanco, EMA, DG Trade, 31° July, 2013
Subject: Call for the Pursuit of a Mutual Recognition Agreement on Good Manufacturing Practices (GMP) Inspections in the Context of an Ambitious and Comprehensive EU-US TTIP Negotiation
“…..we wish to highlightone important recommendation that has been proposed by all of our organisations, namely completing a Mutual Recognition Agreement (MRA) on GMP Inspections.
An MRA on GMP Inspections between the EU and US will have an immediate positive impact on the resources of the regulatory agencies, the European Medicines Agency (EMA), National Competent Authorities (NCAs) of the EU, the Food and Drug Administration (FDA), and on the industry.
The resource savings for regulators should allow for the agencies to work together to identify high-risk sites in need of inspection, including in third countries, and to ensure resources are committed to addressing this need.”
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.
Good progress toward agreed 5 year objective.
3. EU-US TIPP
Progress is slower than expected but objective of MRAs for GMP Inspections remains our high priority.