The European Federation of Pharmaceutical Industry Associations (EFPIA) issued the call earlier today telling in-Pharmatechnologist.com that while drugmakers have taken the new laws into account in their supply chain planning in some cases few options are available.
"Companies envisaged different mitigation measures depending on their supply chain scheme to ensure a continuous supply of safe medicines. However, a change of API supplier poses practical challenges and there might be no alternative solution in case of situation of monosourcing."
The organisation explained that: "Although the deadline of July 2 is fast approaching, there is still a high level of unpredictability regarding the availability of the implementing measures foreseen under the Falsified medicines Directive for the importation of active pharmaceutical ingredients in the EU territory."
EPIA's comments echo those of the European Fine Chemicals Group (EFCG) and regulators such as the MHRA, both of which have recently voiced concerns that the lack of clarity about how the new laws will operate could result in drug shortages.
Solutions
The EFCG acknowledged the EC's decision to set up a list of 'third counties' that are exempt from the new rules - including the requirement they provide a 'written confirmation' of the quality of each API batch shipped to the EU - but suggested that the process could be streamlined.
"EFPIA recommends that third countries such as the USA or Japan that are known by the Commission to have adequate and mature systems should be subject to a simplified procedure for inclusion in the “listing” and potentially be qualified for immediate “listing”.
The US asked to be listed in January this year just a few months after Japan, but as yet neither country has been granted such status.
To date only Switzerland has been added to the list of third countries, while Israel - another exporter of APIs to the European Union (EU) - has been declined.
EFPIA also urged the EC to redouble its efforts to ensure that regulators in China and India - where 70 to 80 per cent of the APIs used in Europe are made - conduct proper oversight of the industry.
"EFPIA strongly encourages the European Commission to intensify the international dialogue with China and India to understand mechanisms for issuing “written confirmations”, surface any blockers or issues."