Q. The European Commission (EC) has published The Falsified Medicines Directive (Directive 2011/62/EU). What elements are covered by this directive and how does it affect the pharmaceutical industry?
Q. Is it sufficient to assure that the API was manufactured to GMPs (e.g., in accordance with 21 CFR Parts 210 and 211)?A. Unfortunately, no. The new prerequisite is that the API must have been manufactured in accordance with GMP that is equivalent to that of the European Union. Such proof requires either a GMP certificate from an EU National Competent Authority (NCA), a "conformity of equivalence" statement from the authority of the non-EU country, or a positive assessment (white-listing) by the EC that the non-EU country's regulatory framework provides equivalent assurance of compliance.
Q. The EU already has mutual recognition agreements in place and is a member of the Pharmaceutical Inspection Co-Operation Scheme (PIC/S). Will these countries be automatically on the white list?
A. No. Non-EU countries must actively apply for an assessment by the EC before they can be added to the white list. Alternatively, these countries could issue a certificate of equivalence. The issue with such a certificate is, however, that its acceptability by the European authorities is uncertain.
The vast majority of APIs imported into the EU originate in China, India, USA, Japan, and Switzerland. So far, only Switzerland is on the white list; Japan is considering applying for white-listing; India considers issuing certificates; China's activities are as yet unclear; and the US FDA has not started considering their options.