Policies and procedures

The European Medicines Agency's policies and procedures ensure that the Agency's long-term vision and goals are translated into concrete steps. They set the boundaries for all major decisions and actions taken by the Agency.

Procedures

Procedures are the specific methods employed to express policies in action in day-to-day operations of the organisation. They include standard operating procedures (SOPs) and work instructions (WINs).

SOPs contain detailed, written instructions to achieve uniformity of the performance of a specific process. The instructions usually cover more than one task or area within the Agency, unit or sector.

WINs contain detailed descriptions of how to perform and record tasks. They may be, for example, detailed written descriptions, flow charts, checklists, pictures, or combinations thereof.

SOPs and WINs are available in the following areas:

• General
• Inspection activities
• Meeting management
• Pharmacovigilance
• Product authorisation lifecycle
• Product development
• Product information
• Referrals

Policies

A policy is any statement by the management at any level that is designed to constrain the actions and decisions of those it affects.

Policies are therefore essential in ensuring the effective planning of processes because they lay down the rules to be followed to ensure that actions and decisions taken in the design and operation of processes serve the business objectives and the needs and expectations of stakeholders.