Throughout the drug development process, from early discovery through launch of a product, regulatory affairs provides input and strategies to ensure that the data and documentation developed are tailored to suit the final registration by the various health authorities worldwide. Our regulatory affairs department analyse and compile documentation from the clinical and non-clinical studies, quality data and the manufacturing process.
This documentation is electronically submitted to the regulatory authorities for assessment after which - if the data are found sufficient to prove the drug's quality, efficacy and safety - we are granted marketing authorisations.
The major part of regulatory activities is after launch of the new product; Changes in the manufacturing process require approval from the regulatory authorities, new indications, new pharmaceutical formulations or additional safety information requires changes in the labelling, and new markets and requirements from regulatory authorities require updates.
Throughout the life-cycle of LEO Pharma products, we continuously provide up-to-date information regarding benefits and risks of our products, based on information from many sources such as preclinical and clinical trials, case reports from healthcare providers, consumers, literature and quality complaints.
International and national legislation regulate the field strictly. LEO Pharma is in compliance with the requirements and we maintain a constant and focused safety surveillance of our products in all markets. Regulatory authorities are continuously kept informed about our evaluations and activities to sustain their confidence in LEO Pharma products.