Website: Regulatory and procedural guidance

The European Medicines Agency (EMEA), in August 2008, created a new section of its website to provide convenient access to the main regulatory and procedural guidance documents relevant to the operation of the centralised authorisation procedure, its preceding steps, and referral procedures. It includes key legislative texts, regulatory guidelines, procedural advice, templates and standard operating procedures, which are available to applicants to guide them through the various regulatory stages involved in developing a medicinal product for human use. The section will be updated regularly to include new or updated guidance documents.