The EMA reacts on the fact that the manufacturing of APIs is moving to areas outside the EU, especially to Asia (mainly China and India). In its Road Map the EMA states: "Another field of growing concern relates to the increasing manufacture of active pharmaceutical ingredients (APIs) outside the EU, and in particular the potential for substandard material to enter the supply chain." and continues "The impact of the increasing globalisation of clinical research and manufacturing and its movement to developing countries (which may be confronted with limited experience and resources, and a less developed regulatory framework) needs careful consideration. In order to address this challenge, the Agency will undertake a number of initiatives.
Among the initiatives, the EMA states:"In the field of the manufacture of APIs and of finished products, the Agency will develop with the Member States the necessary framework for implementing the new antifalsification legislation. The Agency will also build on existing collaboration with its international regulatory partners. This will not only include exchange of information (on inspection planning and outcomes) and pooling of resources to increase inspection coverage, but will also ensure, through existing platforms where possible, a coordinated approach to improving interactions with developing regulatory authorities and capacity-building to facilitate better implementation of good manufacturing practice (GMP) and supervision for manufacturers, with respect to both medicines for human and veterinary use."
Source: EMA Roadmap 2015