Spring Intro 2023

03/03/2023

Pre-submission Phase

Eligibility request – Submit 18 to 7 months before submission of MAA

• Confirms eligibility for centralised procedure, must submit even if you fall under mandatory scope. Timetabled on EMA website (discussed/adopted at next CHMP meeting post-submission deadline)

Request appointment of Rapporteurs – ~7 months before submission of MAA

• The Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC) appoints (co-)rapporteurs to lead the scientific assessment. • They are appointed according to objective criteria to make use of all the available expertise in EU • For advanced therapy medicinal products, (co-)rapporteurs are also appointed from members of the Committee for Advanced Therapies (CAT), who will lead the assessment.

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 (updated Feb 2020): EMA pre-authorisation procedural advice for users of the CP

The Organisation for Professionals in Regulatory Affairs

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Pre-submission Phase

Pre-submission Interaction/Pre-submission meeting – 6 to 7 months before submission of MAA

• Opportunity for applicants to obtain procedural and regulatory advice from the Agency • Discussion around use of accelerated pathway/Conditional Marketing Authorisaion/Exceptional Circumstances

• Facilitates subsequent validation and assessment

Additional Considerations: • Orphan Maintenance • Orphan Similarity

• Familiarises assessment team with dossier & builds relationship with EMA

Name review group – at least 4-6 months before the submission of MAA

• The Name Review Group (NRG) consider whether the proposed invented name could create a public-health concern or potential safety risks. Might take several rounds!

Submit PIP compliance check – 2-4 months before submission of MAA

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: EMA pre-authorisation procedural advice for users of the CP

The Organisation for Professionals in Regulatory Affairs

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