Market Access Europe

For pharmaceutical and biotechnology manufacturers, faster patient access to therapies is a major challenge. In the following section, we will discuss in detail:

BIOMEDICINE

Most drug approval processes in the EU are similar to those of the FDA, such as obtaining pre-approval for the use of drugs in clinical trials. Upon completion of clinical trials, FDA drug approvals follow a centralized pathway, while European approval can follow 3 different pathways, depending on the nature of the drug, timing, and manufacturer preference.

Mutual Recognition Procedure

In this procedure, drugs, approved in one European country and seek further marketing authorizations from other EU countries, which, instead of conducting their own review, agree to recognize the decision of the first country.

Decentralised Procedure

Sponsors may apply for marketing authorization in more than one EU state for products simultaneously, which have not yet been authorized in any EU state and do not fall under the mandatory centralized process.

Centralised Procedure

A single marketing authorization allows the sponsor to market the drug and make it available to patients and healthcare professionals throughout Europe under the "centralized procedure" and is granted by the European Commission after scientific evaluation of the application by the European Medicines Agency.

MEDICAL DEVICE

A medical device can only be sold in Europe with a CE mark. By placing the CE mark on a product, the manufacturer declares that their product complies with all applicable European Medical Device Directives.

Medical Device Classification

Medical Devices are divided into 4 classes according to the increasing level of risk: class I, IIa, IIb, III.

An “in vitro diagnostic medical device” is a “device” allowing a practitioner or a person to make a medical diagnosis, from a sample of bodily fluid taken from the body and studied outside the body.

The regulations governing medical devices are constantly changing, and today we are witnessing more demanding laws that promote better quality and safety of products.

Medical devices with a valid certificate under one of the previously applicable directives (93/42/EC or 90/385/EEC) on May 26, 2021, can continue to be placed on the market during the validity of this certificate, at the latest until May 26, 2024 under certain conditions.

Dietary supplements

In the European Union, dietary supplements are regulated as foods. Specific harmonized legislation regulates vitamins, minerals and source substances.

For ingredients other than vitamins and minerals, the European Commission has established harmonized rules to protect consumers from any potential health risks and maintains a list of substances known or suspected to have harmful effects on health.

The European Food Safety Authority (EFSA) is one of the main agencies of the European Union responsible for risk assessment in the field of foodstuffs.

Registration of dietary supplements in France

The Directorate General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) contributes to the design and implementation of economic policy, ensuring the proper functioning of markets, for the benefit of consumers and businesses.

The decree n°2006-352 of March 20, 2006 requires to declare to the DGCCRF the marketing of dietary supplements. This declaration has a double objective:

– To better know the market in order to facilitate controls,
– To update the positive lists of plants and substances.

All declarations must include legible labelling as well as information allowing the admissibility of the application to be judged with regard to the requirements of Articles 15 and 16.

This declaration is made through a dedicated teleservice: TeleIcare, which allows to directly transmit the declaration of marketing of food supplements to the DGCCRF.