Many of the details of the legislation, the Falsified Medicines Directive (FMD), have yet to be worked out. The EU legislative body, which consists of the European Parliament and the Council of Ministers, represents the governments of the union's 27 member states. The legislature has decided to delegate the task of finishing the job to the European Commission, the EU's executive body. After that task is complete, any additional details will still have to be approved by the two legislative arms before finalization and implementation can occur.
"We're pleased with what we have got but we've got reservations about the details because there are a lot of unanswered questions about how the legislation will be implemented," says Tony Scott, adviser to the European Fine Chemicals Group (EFCG), which represents European-based API producers.During the next 18 months and before the FMD's implementation, EU states will have to incorporate the directive into their national statutes. Some experts believe that the Commission could take much longer than this allotted timeframe to fill in the gaps, particularly with regard to the new rules regarding APIs and packaging.
Most APIs used in Europe are imported, mainly from India and China. The European fine-chemical manufacturers failed to persuade the legislators to agree to a mandatory system of official inspections to ensure that API plants comply with GMPs. European API producers have long complained about unfair competition from substandard Asian imports.
Instead, the legislation makes auditing of API plants by drug manufacturers obligatory. It also requires countries exporting APIs into Europe to have plant-inspection systems and GMP standards equivalent to those in the EU.
The Commission will have to decide what is "equivalent" and establish a process for verification of equivalence. The legislation appears to be flexible on this matter. It does not lay down, for example, that GMP standards for active ingredients will be the same as those in existing EU regulations.
"The Commission will certainly need to consider a transition period for implementation of this provision (on equivalence in standards of API exporting countries)," says Julie Marechal-Jamil, senior manager for quality and regulatory affairs at the European Generic Medicines Association (EGA).
FMD also makes GMP for excipients obligatory. But it has left to the Commission the decision about what GMP standards must be applied. Excipient producers seem confident that the existing GMPs for food production will be permitted.