EN

cart
Menu
Client area
Log out
Client area
Log in
Search
Search

There was an error performing your search

We could not find any results for your search

Menu

Your shopping cart

Amount

Total (VAT incl.)

VAT (21%)
Total
You have not added any reports to the cart yet.
Request reports

Events and news

Blog
Home > Blog > Regulatory Affairs

Accessing the EU Market: Becoming a suitable CMO for Europe (III)

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:

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.

 

Bibliography

  1. Pharmaceutical industry EU trade partners– Statista

  2. Contract Manufacturing Organisations poised for great opportunities

  3. Comercio internacional de mercancías- Eurostat Statistics

 

Back

Related posts

How to proceed with an active ingredient that can be effective...

Although numerous clinical trials are underway, there is currently no evidence from controlled clinical trials to recommend...

Read more

Accessing the European Pharma Market: becoming a MAH through...

Positioned as the second largest pharmaceutical market in the world and showing a steady and extensive growth pattern, Europe’s...

Read more

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience

Innovation

Leading innovation

Client oriented

100% client oriented

We are at your complete disposal for any inquiry

Thank you for getting in touch! We will contact you as soon as possible to help you out
There has been an error while submitting your form, please try again, or call us at 912 77 10 76
Schedule appointment

Schedule a video call with our field experts

schedule
We use "cookies" to improve your experience on our site. Cookies enable us to tailor messages and display ads to your interests. They also help us understand how our site is being used. By continuing to use our site you consent to use our cookies.