Spring Intro 2023

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03/03/2023

Commission Decision Phase

Recall from earlier slide that EMA has no legal decision making powers

– that’s why the EMA form an opinion, and the EU Commission make a final legally binding decision.

Day 210: Adoption of CHMP Opinion

Day 215: Send in product information and Annex A in all EU languages

Day 229: Member states send linguistic comments on the product information

Day 235: Send in final translations

Day 237: Receive the Opinion and Annexes in all EU languages, send to the EU Commission

Day 239-261: Draft Commission Decision (standing committee written procedure)

Day 277: Final Commission decision notification (+67 days maximum)

Access

Submission and validation of MAA

Research and development (several years before MAA)

Pre submission (~18 months before MAA)

EU Commission decision

Evaluation of MAA (~ 1 year)

EMA opinion

Continuous Safety Monitoring

EMA link: Marketing authorisation guidance documents

The Organisation for Professionals in Regulatory Affairs

Post Authorisation Phase

• After approval, an EPAR (European Public Assessment Report) is published on the EMA website – great source of learning about competitor products, EMA position re certain risks, efficacy requirements for certain diseases, etc. • After medicines are granted marketing authorisation by the European Commission, pricing and access discussions start at a National level. • Time to start submitting post-approval commitments as well as other variations for new formulations, new indications, paediatric results, and safety updates, etc • EMA are continuously monitoring safety/side effects through events reported by patients and healthcare professionals, scientific review papers

• Requirement to submit Periodic Safety Update Reports (PSURs)