api Outlook & policy

Compliance, competitiveness and sustainability have to remain the key drivers for the European API business with no compromise on quality

Clients are demanding more quality and more reliability from their API sources to avoid public health risks

The trend towards outsourcing by big pharmaceutical multinationals is expected to continue growing, which will result in an increased demand for quality APIs;

Companies are increasing their size to face global competition. Mergers and acquisitions are taking place in order to pursue global projects;

There is a growing investment in R&D for API production processes, as well in quality, environment and safety, resulting in better, safer and cleaner technologies and substantial increase of pharmaceutical technology know-how and intellectual property;

Sustainability and compliance have to remain the key drivers for the APIs business with no compromise on quality;

Companies should increase their size to face global competition. Mergers and acquisitions are taking place in order to pursue globalisation projects;

API manufacturers ask for global harmonised regulations with an increasingly strong relationship between the EU and the USA.

An effective Industrial Policy for the Active Pharmaceutical Ingredients should improve the competitiveness of the EU API industry as well as facilitate its better access to other geographical areas.

EFCG therefore advocates for:

Strong regulatory measures to promote the use of quality APIs within Europe as an absolute necessity to protect public health and patients in Europe. One such measure would be to implement mandatory inspections of non-EU production sites whose APIs are sold within the European territory.

EU authorities to encourage the removal of barriers such as regulatory or tariff-based hurdles in order to promote the entry of European products in higher growth non-EU markets by encouraging EU Authorities to enhance the relationship with the US FDA in order to work towards a joint regulatory system and a mutually recognised inspection system for manufacturing sites. This would facilitate the entry of European manufactured APIs into the US pharmaceutical system, which is the biggest and fastest growing pharmaceutical market in the world.

EU member states to strengthen their cooperation, in order to build a common regulatory harmonised system.