Pharmaceutical companies are faced with the need to outsource the manufacturing processes of their products for a variety of reasons and are directing their resources towards marketing, rather than production and drug discovery.
In recent years, the volume of generic drug sales has been increasing rapidly in Europe, whereas the outsourcing of branded pharmaceuticals has been growing at a slower rate. Many branded pharmaceuticals have moved towards maturity and late growth stages in the product life cycle. Hence, utilisation levels of these plants are likely to grow to unsustainable levels. This makes outsourcing a viable option and at the same time Europe pharma market attractive to investors.
Being a suitable CMO for Europe is ideal for Non-EU Manufacturing Companies that aren’t interested in obtaining MAH status but are looking to maximise the use of their facilities and drive up sales, not only in Europe but also worldwide. Through doing this, companies strengthen their image, and are able to significantly increase exports, as they become recognised as an international company in terms of quality.
In the highly competitive contract manufacturing outsourcing (CMO) market, the Asian CMO market is on the rise, is one of the fastest growing segments in the pharma industry. Becoming a suitable CMO for Europe is one of the different strategies to be considered to accessing the EU Market.
In order to become a CMO for European products, companies must request and undergo a voluntary EU authority inspection in order to obtain the EU GMP Certificate. It is essential to be well advised and supported by experts to ensure a cost-effectiveness strategy.
Following completion of the process, the GMP certificate obtained is valid across Europe and the company is able to be included as manufacturer in an European dossier.
The strategy described is one of the main possible strategies for accessing the European pharmaceutical market, although different strategies may be implemented depending on the company needs. If interested, you could read more about the European pharma market and other strategies to access this market in the following posts:
- Pharmaceutical Market in EU
- Accessing the European Pharma Market: becoming a MAH through dossier acquisition.
- Accessing the European Pharma Market: becoming a MAH through dossier adaptation (II)
At Azierta, science and health consultancy firm, we provide global support to access the European Pharma Market to Non-European companies. We are experts in Regulatory Affairs, Compliance and Requirement Related Services.
For further information, please visit our website European Market Access Support Services, do not hesitate to contact us in case of any doubt.