Information & News
Background of this Conference
According to the European Medicines Agency (EMEA) and the World Health
Organisation (WHO) counterfeit medicines are manufactured wilfully outside
the scope of any established standards of safety, quality and efficacy and
their corresponding control mechanism. They are deliberately and
fraudulently mislabelled with respect to identity and/or source.
Counterfeiting can apply to both branded and generic products and
counterfeit medicines may include products with the correct ingredients but
fake packaging, with the wrong ingredients or with insufficient active
ingredients.
Industry and regulators are equally concerned about the rise in counterfeit
drugs which are increasingly present even in better controlled markets.
At the end of 2008 the European Commission made a legal proposal to combat
counterfeits: there is an alarming increase in the EU of falsified, illegal
medicinal products, which pose a major threat to European industry and
European patients. There is a clear need for the Commission to act now!
In January 2009 the FDA (CDER and ORA) announced a voluntary Secure Supply
Chain Pilot Program for finished drug products and APIs. This program will
assist FDA in its efforts to prevent the importation of adulterated,
misbranded, or unapproved drugs. In addition FDA issued two Draft Guidances
for Industry in 2009:
- Standards for Securing the Drug Supply Chain – Standardized
Numerical Identification for Prescription Drug Packages (January
2009)
- Incorporation of Physical-Chemical Identifiers into Solid Dosage
Form Drug Products for Anticounterfeiting (July 2009)
It is the aim of this conference to inform participants about the latest
regulatory requirements (WHO, EU, EMEA, FDA, Brazil, etc. ) and the measures
the pharmaceutical industry has to take to combat counterfeit medicines.
Anti-Counterfeit Initiatives / Activities / Documents
EDQM
FDA
WHO
Europe
Legal Proposal
Other Anti-Counterfeit Initiatives
