Module 1 2021

25/06/2021

Influencing regulatory guidance development (EU example) – Output/Feedback

Industry Position/comments

Company position

Comments published

Comments published and why (not) considered

The Organisation for Professionals in Regulatory Affairs

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From Consultation to Legislation The EU Pharmaceutical Strategy Example

Legislation Adoption

Legislation Evaluation ongoing

EC Adoption of Legal Proposal

Impact Assessment (IA)

Inception Impact Assessment (IIA) & consultation

Capacity to influence

Roadmap consultation Studies

Company corporate and government affairs, Trade organisation working groups, horizon scanning, general external engagement

Remarks: ● IA provides a first description of the problem and possible policy options along with an overview of the different planned stages in the development of the initiative, including foreseen impact assessment work and consultation of stakeholders. ● IA must set out the logical reasoning that links the problem, its underlying causes, the objectives and a range of policy options to tackle the problem. They must present the likely impacts of the options, who will be affected by them and how.

The Organisation for Professionals in Regulatory Affairs

20

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