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. Artemisinin combined medicines, Kampala, February 2009 2 |2 |SynopsisSynopsis  Dossier requirements  Pre-authorisation assessment process  Timelines (example)  Post-authorisation assessments

3. Artemisinin combined medicines, Kampala, February 2009 3 |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. Artemisinin combined medicines, Kampala, February 2009 4 |4 | Dossier requirements (II)

5. Artemisinin combined medicines, Kampala, February 2009 5 |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. Artemisinin combined medicines, Kampala, February 2009 6 |6 | Pre-authorisation Assessment (II)  Steps (II) applicant‘s response assessment approval list of outstanding issues with/without commitments assessment of clarifications refusal approval with/without commitments clock-stop

7. Artemisinin combined medicines, Kampala, February 2009 7 |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. Artemisinin combined medicines, Kampala, February 2009 8 |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/chmp templates/artemplates.htm

9. Artemisinin combined medicines, Kampala, February 2009 9 |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. Artemisinin combined medicines, Kampala, February 2009 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 )