EU Product Registration Ep.1

What are the most significant challenges when entering the European market to distribute pharmaceutical products for the first time?

The pharmaceutical industry has undergone significant development in recent years regarding regulations. Several new regulations have been issued, making it increasingly complex to stay compliant. This poses a significant burden for many companies, as they may not be fully aware of all the regulations in place.

What is the role of the European Medicines Agency (EMA), and how can they influence decisions regarding the approval of products and the assessment of their benefit ratios?

The European Medicines Agency (EMA) is a decentralized agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of all medicines across Europe. The EMA plays a crucial role in providing guidance and advice during the development and registration of medicines. However, when it comes to marketing authorization applications, the EMA is not responsible for the initial evaluation of the majority of drugs. Instead, this task falls under the jurisdiction of the local competent authorities of each European member state. The EMA is primarily in charge of evaluating specific categories of drugs, including those intended to treat rare diseases, biotechnological process medicines, advanced therapies, and medications used for the treatment or prevention of specific diseases such as diabetes, oncology drugs, and viral diseases.