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For non-EU small and medium-sized pharmaceutical enterprises, establishing a foothold in the European market is essential. Leveraging the European Medicines Agency’s (EMA) Small and Medium-Sized Enterprise (SME) status can offer significant regulatory and financial benefits. However, non-EU companies must navigate the process through an EU-registered third party, ideally a seasoned SME regulatory consultancy. Advantages of […]

The process of meeting Chemistry, Manufacturing, and Control (CMC) requirements poses significant challenges for drug developers, particularly in the rare disease sector. Non-EU sponsors aiming to conduct clinical trials in Europe encounter additional complexities, as the regulatory expectations of the European Medicines Agency (EMA) often differ from those of other regulatory agencies, such as the

To successfully transition clinical trials to the EU Clinical Trials Information System (CTIS) from those previously approved under the EU Clinical Trials Directive, sponsors must undertake several essential preparatory measures. These preparatory steps can be extensive and often misunderstood, underscoring the necessity for thorough preparation. Initial Preparations Begin by ensuring that you have a statement

The implementation of the Clinical Trials Regulation (CTR) has introduced additional complexities for non-EU sponsors, particularly concerning the obligations of the legal representative. Non-EU sponsors are mandated to appoint an EU-based legal representative to ensure compliance with CTR standards. While the requirement for a legal representative is not new, the CTR explicitly tasks them with

The European Medicines Agency (EMA) offers a pivotal advantage to Small and Medium-Sized Enterprises (SMEs) engaged in the development of medicinal products for both human and veterinary applications. The designation of SME Status serves as a strategic initiative designed to foster innovation and encourage the creation of novel therapies. Instituted through the SME Regulation of

Within the context of the Clinical Trial Regulation, there is an essential emphasis on transparency. It is imperative that sponsors recognize their obligations concerning data transparency for trials executed in the EU, specifically those concluding under the Clinical Trial Directive (CTD). Sponsors are obligated to ensure that results from such studies are submitted to the