Our regulatory monitoring

Sunnikan offers regulatory assistance and monitoring tools that enable clients to keep up to speed with the latest legislation and regulations as well as recommendations from France, Europe and the United States. This ensures clinical research processes remain compliant with the regulations in force and allow subscribers to plan ahead and understand the implications for their quality assurance systems.

Sunnikan publishes a monthly  'Research With Human Subjects' regulatory monitoring newsletter:

• Assessing the framework documents involved: French, European (excluding national regulations) and American legislation, regulations and recommendations, such as the French public health code, ICH recommendations, the Federal Register, FDA, etc.
• Monitoring frameworks that are indirectly linked to clinical research: personal data protection, DMOS law, good practices in experimental medication manufacturing, the French National Medical Council, etc.
• Products involved: medication, medical equipment (excluding FDA).

The scope of Sunnikan's 'Genetically-Modified Organism' (GMO) regulatory monitoring includes specific regulations pertaining to basic research, pre-clinical research (GMO handling, transgenic animals, administering GMOs to animals) and clinical research surrounding GMOs.

• Products involved: innovative therapeutic medication that contains or is based on a GMO
• Research reference frameworks: legislation, French, EU and international regulations and recommendations (ICH, the Convention On Biodiversity and the Nagoya Protocol)
• Indirectly related frameworks such as GMO deliberate release and contained use

The scope of application is essentially restricted to French and EU regulations (EMA, European Commission).

Sunnikan contributes to the pharmacovigilance regulatory monitoring research conducted by PV Focus: www.safetyobserver.com

The monthly newsletter includes a summary of texts and direct links to all new regulations and initiatives that fall within the scope of pharmacovigilance. This includes regulatory texts, draft bills, product notifications, etc.