Market Access with AEMPS: Your Guide to Spain’s Pharmaceutical Regulatory Authority

Core Functions of AEMPS

•     Authorization of Medicinal Products: Evaluating and granting marketing authorizations for new medicines to ensure they meet rigorous standards of quality, safety, and efficacy. administracion.gob.es
•     Pharmacovigilance: Monitoring the safety of medicines post-marketing to promptly identify and manage adverse reactions.
•     Regulation of Clinical Trials: Overseeing the authorization and conduct of clinical trials to ensure compliance with ethical and scientific standards. aemps.gob.es
•     Control of Medical Devices and Cosmetics: Ensuring that medical devices and cosmetic products meet safety and performance requirements before they reach the market.

Leadership and Key Contacts

Contact Details for AEMPS

Challenges in Working with AEMPS

•     Understanding Regulatory Procedures: Familiarity with AEMPS’ authorization processes and requirements is crucial for successful market access.
•     Timely and Accurate Submissions: Ensuring that all necessary documentation is complete and submitted promptly to facilitate evaluation processes.
•     Compliance with National and EU Regulations: Navigating the complex regulatory environment that includes both Spanish and European Union directives.

Opportunities / Solutions with Justin Stindt Consultants

•     Expert Consultant AEMPS Submissions: Creating high-quality submissions for marketing authorizations and clinical trial applications.
•     Market Access AEMPS Strategies: Developing strategies that align with AEMPS’ regulatory framework to optimize market access.
•     Specialist AEMPS Processes: Providing insights into AEMPS’ procedures to enhance compliance and expedite approvals.