The assessment process in “stringent” authorities

1. The assessment process in “stringent” authorities Regine Lehnert Training workshop: Regulatory requirements for registration of Artemisinin based combined medicines and assessment of data which are submitted to regulatory authorities, February 2009

2. Synopsis • Dossier requirements • Pre-authorisation assessment process • Timelines (example) • Post-authorisation assessments

3. Dossier requirements (I) • Common Technical Document (CTD) ICH (2001) Specification for application dossier for the registration of medicinal products. 5 Modules : • Administrative and prescribing information • Overview and summary of modules 3 to 5 • Quality (pharmaceutical documentation) • Safety (toxicology studies) • Efficacy (clinical studies)

4. Dossier requirements (II)

5. Pre-authorisation Assessment (I) • Steps (I) First assessment of the submitted data quality nonclinical clinical (pk/S+E/PhV) letter of deficiency (list of questions) clock-stop

6. Pre-authorisation Assessment (II) • Steps (II) applicant‘s response assessment approval list of outstanding issues with/without commitmentsassessment of clarifications refusal approval with/without commitments clock-stop

7. Pre-authorisation Assessment (III) • Timelines: European „centralised“ licensure • First assessment: ≈ 80 days • Response assessment: ≈ 30 days • Assessment of clarifications: ≈ 30 days Of note: European system – involvement of other member states with possibility to comment on each assessment report. → altogether max. 210 days [ → + Commission decision (≤ 90 days)]

8. Pre-authorisation Assessment (IV) • Assessment templates and guidance • for each discipline • for each phase • available on EMEA website: http://www.emea.europa.eu/htms/human/chmptemplates/artemplates.htm

9. Post authorisation assessments (I) • Follow-up measures(according to timelines specified in a company‘s letter of undertaking at the time of licensure) • Variations(upon application) • pharmaceutical - major/minor • nonclinical/clinical - major/minor • Renewal(once, 5 years after licensure)

10. Post authorisation assessments (II) • Periodic Safety Update Reports • 6-monthly for the first 2 years • yearly for the next 2 years • after 5 years (time of renewal) • 5-yearly thereafter • Other pharmacovigilance issues(event-driven), e.g. • urgent safety restriction • DHCPL • class reviews)